Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT01612767
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2012-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
BIOHELIX-I Bare Metal Stent Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amy.culley@biotronik.com', 'phone': '503-451-8034', 'title': 'Amy Culley, Director of Vascular Intervention', 'organization': 'BIOTRONIK'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '36 Months', 'eventGroups': [{'id': 'EG000', 'title': 'Pro-Kinetic Energy Stent', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant', 'otherNumAtRisk': 329, 'deathsNumAtRisk': 311, 'otherNumAffected': 118, 'seriousNumAtRisk': 329, 'deathsNumAffected': 27, 'seriousNumAffected': 202}], 'otherEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 77, 'numAffected': 59}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 35, 'numAffected': 31}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 55, 'numAffected': 44}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 30, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 35, 'numAffected': 30}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muskuloskeletal injury/fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 29, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 30, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Arrhyrhmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Atrial arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unspecified arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiopulmonary arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 42, 'numAffected': 33}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestive/worsening heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diaphragmatic stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elective pacemaker/ICD implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated cardiac enzymes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left ventricle penetration observed on LV gram', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peri-procedural myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Planned PCI procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Planned routine angiography', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stenosis/occlusion of target lesion within non-study stented segment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stenosis/restenosis of non-target lesion in target vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stenosis/restenosis of non-target vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 36, 'numAffected': 27}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Valvular heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Actinic keratosis/cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cicatricial changes to the left lower eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contact dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-healing wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia and/or hypomagnaesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left adrenal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thyroid nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute gangrenous cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anastomotic disruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atypical chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Candida esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elective bariatric surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epigastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epiploic appendagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal ilius', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea and/or vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tubulovillous adenoma of ascending colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute onset chronic renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contrast induced increased creatinine/acute renal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostatic bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding requiring treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coumadin toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma - TAVI access site bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Supratherapeutic INR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HSV pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MRSA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical site dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Calcar fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genu varus deformity of right knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal injury/fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening/degenerative osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Brain cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hiatal hernie', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Percutaneous endoscopic gastrostomy complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 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'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic Fibrotic Lung Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral vascular disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-surgical bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Saphenous vein insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction to contrast media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction with angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased hearing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Possible PCI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pacemaker manfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Target Vessel Failure Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-Kinetic Energy Stent', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'classes': [{'title': 'Overall Target Vessel Failure Rate', 'categories': [{'measurements': [{'value': '9.06', 'groupId': 'OG000', 'lowerLimit': '6.15', 'upperLimit': '12.76'}]}]}, {'title': 'Cardiac death', 'categories': [{'measurements': [{'value': '0.95', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '2.74'}]}]}, {'title': 'Myocardial infarction', 'categories': [{'measurements': [{'value': '1.58', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '3.65'}]}]}, {'title': 'Ischemia-driven target vessel revascularization', 'categories': [{'measurements': [{'value': '7.26', 'groupId': 'OG000', 'lowerLimit': '4.65', 'upperLimit': '10.69'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months post-index procedure', 'description': 'The primary endpoint for the Pro-Kinetic Energy Stent is the target vessel failure rate at 9-months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction and ischemia-driven target vessel revascularization.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Target Vessel Failure Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-Kinetic Energy Stent', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'classes': [{'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.22', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.76', 'groupId': 'OG000'}]}]}, {'title': '24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.26', 'groupId': 'OG000'}]}]}, {'title': '36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.61', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 12, 24 and 36 months post-index procedure', 'description': 'Evaluate the target vessel failure rate at 1, 12, 24, and 36 months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.'}, {'type': 'SECONDARY', 'title': 'Target Vessel Failure Rate - Contribution of Individual Event Types', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}, {'value': '301', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-Kinetic Energy Stent - 1 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG001', 'title': 'PRO-Kinetic Energy Stent - 12 Months', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG002', 'title': 'PRO-Kinetic Energy Stent - 24 Months', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG003', 'title': 'PRO-Kinetic Energy Stent - 36 Months', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'classes': [{'title': 'Cardiac death', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.96', 'groupId': 'OG001'}, {'value': '2.30', 'groupId': 'OG002'}, {'value': '4.07', 'groupId': 'OG003'}]}]}, {'title': 'Myocardial infarction', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}, {'value': '1.61', 'groupId': 'OG001'}, {'value': '2.00', 'groupId': 'OG002'}, {'value': '3.50', 'groupId': 'OG003'}]}]}, {'title': 'Ischemia-driven target vessel revascularization', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}, {'value': '8.97', 'groupId': 'OG001'}, {'value': '10.23', 'groupId': 'OG002'}, {'value': '12.46', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 12, 24 and 36 months post-index procedure', 'description': 'Contribution of each event type (cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization) to composite rate of target vessel failure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.'}, {'type': 'SECONDARY', 'title': 'Overall Target Vessel Revascularization Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '312', 'groupId': 'OG002'}, {'value': '303', 'groupId': 'OG003'}, {'value': '289', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-Kinetic Energy Stent - 1 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG001', 'title': 'PRO-Kinetic Energy Stent - 9 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG002', 'title': 'PRO-Kinetic Energy Stent - 12 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG003', 'title': 'PRO-Kinetic Energy Stent - 24 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG004', 'title': 'PRO-Kinetic Energy Stent - 36 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'classes': [{'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}, {'value': '7.86', 'groupId': 'OG001'}, {'value': '9.62', 'groupId': 'OG002'}, {'value': '11.55', 'groupId': 'OG003'}, {'value': '13.84', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 9, 12, 24 and 36 months post-index procedure', 'description': 'Evaluate the overall target vessel revascularization rate of the PRO-Kinetic Energy stent. The rate includes both ischemia-driven revascularization procedures of the target vessel, as well as revascularization procedures of the target vessel without prior clinical symptoms.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.'}, {'type': 'SECONDARY', 'title': 'Overall Target Lesion Failure Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}, {'value': '308', 'groupId': 'OG003'}, {'value': '300', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-Kinetic Energy Stent - 1 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG001', 'title': 'PRO-Kinetic Energy Stent - 9 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG002', 'title': 'PRO-Kinetic Energy Stent - 12 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG003', 'title': 'PRO-Kinetic Energy Stent - 24 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG004', 'title': 'PRO-Kinetic Energy Stent - 36 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'groupId': 'OG000'}, {'value': '8.41', 'groupId': 'OG001'}, {'value': '9.84', 'groupId': 'OG002'}, {'value': '11.68', 'groupId': 'OG003'}, {'value': '15.33', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 9, 12, 24 and 36 months post-index procedure', 'description': 'Evaluate the target lesion failure rate of the PRO-Kinetic Energy stent. Target lesion failure includes cardiac death, MI, and ischemia-driven target lesion revascularization.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.'}, {'type': 'SECONDARY', 'title': 'Target Lesion Failure Rate - Contribution of Individual Event Types', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}, {'value': '308', 'groupId': 'OG003'}, {'value': '300', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-Kinetic Energy Stent - 1 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG001', 'title': 'PRO-Kinetic Energy Stent - 9 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG002', 'title': 'Pro-Kinetic Energy Stent - 12 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG003', 'title': 'Pro-Kinetic Energy Stent - 24 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG004', 'title': 'Pro-Kinetic Energy Stent - 36 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'classes': [{'title': 'Cardiac death', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.95', 'groupId': 'OG001'}, {'value': '0.96', 'groupId': 'OG002'}, {'value': '2.30', 'groupId': 'OG003'}, {'value': '4.07', 'groupId': 'OG004'}]}]}, {'title': 'Myocardial infarction', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}, {'value': '1.58', 'groupId': 'OG001'}, {'value': '1.61', 'groupId': 'OG002'}, {'value': '2.00', 'groupId': 'OG003'}, {'value': '3.50', 'groupId': 'OG004'}]}]}, {'title': 'Ischemia-driven target vessel revascularization', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}, {'value': '6.60', 'groupId': 'OG001'}, {'value': '8.04', 'groupId': 'OG002'}, {'value': '8.61', 'groupId': 'OG003'}, {'value': '10.07', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 9, 12, 24, and 36 months post-index procedure', 'description': 'The contribution of each individual event of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization to the overall rate of target lesion failure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.'}, {'type': 'SECONDARY', 'title': 'Overall Target Lesion Revascularization Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '312', 'groupId': 'OG002'}, {'value': '303', 'groupId': 'OG003'}, {'value': '289', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-Kinetic Energy Stent - 1 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG001', 'title': 'PRO-Kinetic Energy Stent - 9 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG002', 'title': 'PRO-Kinetic Energy Stent - 12 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG003', 'title': 'PRO-Kinetic Energy Stent -24 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG004', 'title': 'PRO-Kinetic Energy Stent - 36 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'classes': [{'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}, {'value': '7.23', 'groupId': 'OG001'}, {'value': '8.65', 'groupId': 'OG002'}, {'value': '9.24', 'groupId': 'OG003'}, {'value': '10.37', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 9, 12, 24 and 36 months post-index procedure', 'description': 'Evaluate the overall target lesion revascularization rate associated with the PRO-Kinetic Energy stent. The overall target lesion revascularization rate includes both ischemia-driven revascularization procedures of the target lesion, as well as revascularization procedures of the target lesion without prior clinical symptoms.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.'}, {'type': 'SECONDARY', 'title': 'Composite of All-cause Mortality and All-cause MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '317', 'groupId': 'OG002'}, {'value': '314', 'groupId': 'OG003'}, {'value': '311', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-Kinetic Energy Stent - 1 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG001', 'title': 'PRO-Kinetic Energy Stent - 9 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG002', 'title': 'PRO-Kinetic Energy Stent - 12 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG003', 'title': 'PRO-Kinetic Energy Stent - 24 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG004', 'title': 'PRO-Kinetic Energy Stent - 36 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'classes': [{'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}, {'value': '3.12', 'groupId': 'OG001'}, {'value': '3.79', 'groupId': 'OG002'}, {'value': '7.32', 'groupId': 'OG003'}, {'value': '11.25', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 9, 12, 24, and 36 months post-index procedure', 'description': 'Characterize the overall safety of the PRO-Kinetic Energy stent by evaluating the composite rate of all-cause mortality and all-cause myocardial infarction.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.'}, {'type': 'SECONDARY', 'title': 'All-cause Mortality and All-cause MI - Contribution of Individual Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '317', 'groupId': 'OG002'}, {'value': '314', 'groupId': 'OG003'}, {'value': '311', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-Kinetic Energy Stent - 1 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG001', 'title': 'PRO-Kinetic Energy Stent - 9 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG002', 'title': 'PRO-Kinetic Energy Stent - 12 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG003', 'title': 'PRO-Kinetic Energy Stent - 24 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG004', 'title': 'PRO-Kinetic Energy Stent - 36 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'classes': [{'title': 'All-cause mortality', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '1.87', 'groupId': 'OG001'}, {'value': '2.52', 'groupId': 'OG002'}, {'value': '5.73', 'groupId': 'OG003'}, {'value': '8.68', 'groupId': 'OG004'}]}]}, {'title': 'Cardiac mortality', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.93', 'groupId': 'OG001'}, {'value': '0.95', 'groupId': 'OG002'}, {'value': '2.23', 'groupId': 'OG003'}, {'value': '3.86', 'groupId': 'OG004'}]}]}, {'title': 'Non-cardiac mortality', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.93', 'groupId': 'OG001'}, {'value': '1.58', 'groupId': 'OG002'}, {'value': '3.50', 'groupId': 'OG003'}, {'value': '4.82', 'groupId': 'OG004'}]}]}, {'title': 'All-cause MI', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}, {'value': '1.56', 'groupId': 'OG001'}, {'value': '1.58', 'groupId': 'OG002'}, {'value': '1.91', 'groupId': 'OG003'}, {'value': '3.22', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 9, 12, 24, and 36 months post-index procedure', 'description': 'Contribution of the individual rates of mortality and myocardial infarction to the overall composite safety rate.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.'}, {'type': 'SECONDARY', 'title': 'Stent Thrombosis Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}, {'value': '305', 'groupId': 'OG003'}, {'value': '293', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-Kinetic Energy Stent - 1 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG001', 'title': 'PRO-Kinetic Energy Stent - 9 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG002', 'title': 'PRO-Kinetic Energy Stent - 12 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG003', 'title': 'PRO-Kinetic Energy Stent - 24 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG004', 'title': 'PRO-Kinetic Energy Stent - 36 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'classes': [{'title': 'Definite stent thrombosis', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}, {'value': '1.0', 'groupId': 'OG003'}, {'value': '1.4', 'groupId': 'OG004'}]}]}, {'title': 'Probable stent thrombosis', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}, {'value': '0.3', 'groupId': 'OG003'}, {'value': '0.3', 'groupId': 'OG004'}]}]}, {'title': 'Total definite / probable stent thrombosis', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}, {'value': '1.3', 'groupId': 'OG003'}, {'value': '1.7', 'groupId': 'OG004'}]}]}, {'title': 'Possible stent thrombosis', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}, {'value': '1.6', 'groupId': 'OG003'}, {'value': '2.7', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 9, 12, 24 and 36 months post-index procedure', 'description': 'Evaluate the stent thrombosis rate associated with the PRO-Kinetic Energy stent. Stent thrombosis was classified according to both timing and evidence as outlined by the ARC definition of stent thrombosis. Participants were included in the evaluations at visit intervals if they had a visit at the specified interval or a thrombosis was reported at or before the visit.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.'}, {'type': 'SECONDARY', 'title': 'Index Procedure Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-Kinetic Energy Stent', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'classes': [{'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Index procedure', 'description': 'Evaluate the index procedure success associated with the implant of the PR-Kinetic Energy stent. procedure success is defined as the successful delivery and deployment of the investiational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of \\< 30% by operator visual estimate without the occurrence of cardiac death, any MI (target vessel or non-target vessel) or TLR prior to hospital discharge.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Device Success During the Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-Kinetic Energy Stent', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'classes': [{'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Index procedure', 'description': 'Evaluate the device success associated with the implant of the PRO-Kinetic Energy stent. Device success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with standard post-dilation (if applicable) to attain a final residual stenosis of \\< 30% by operator visual estimate.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lesion Success During the Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-Kinetic Energy Stent', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'classes': [{'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Index procedure', 'description': 'Evaluate the lesion success associated with the implant of the PRO-Kinetic Energy stent. Lesion success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of \\< 30% by operator visual estimate.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Angina Pectoris Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '326', 'groupId': 'OG002'}, {'value': '307', 'groupId': 'OG003'}, {'value': '303', 'groupId': 'OG004'}, {'value': '296', 'groupId': 'OG005'}, {'value': '283', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-Kinetic Energy Stent - Baseline', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG001', 'title': 'PRO-Kinetic Energy Stent - Discharge', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG002', 'title': 'PRO-Kinetic Energy Stent - 1 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG003', 'title': 'PRO-Kinetic Energy Stent - 9 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG004', 'title': 'PRO-Kinetic Energy Stent - 12 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG005', 'title': 'PRO-Kinetic Energy Stent - 24 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}, {'id': 'OG006', 'title': 'PRO-Kinetic Energy Stent - 36 Month', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'classes': [{'title': 'No Angina', 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000'}, {'value': '97.3', 'groupId': 'OG001'}, {'value': '93.9', 'groupId': 'OG002'}, {'value': '88.9', 'groupId': 'OG003'}, {'value': '94.7', 'groupId': 'OG004'}, {'value': '95.3', 'groupId': 'OG005'}, {'value': '94.3', 'groupId': 'OG006'}]}]}, {'title': 'Total Stable Angina', 'categories': [{'measurements': [{'value': '61.7', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}, {'value': '11.1', 'groupId': 'OG003'}, {'value': '5.0', 'groupId': 'OG004'}, {'value': '4.7', 'groupId': 'OG005'}, {'value': '4.9', 'groupId': 'OG006'}]}]}, {'title': 'Stable Angina - Class I', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '3.7', 'groupId': 'OG002'}, {'value': '6.2', 'groupId': 'OG003'}, {'value': '2.0', 'groupId': 'OG004'}, {'value': '2.4', 'groupId': 'OG005'}, {'value': '2.8', 'groupId': 'OG006'}]}]}, {'title': 'Stable Angina - Class II', 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}, {'value': '2.9', 'groupId': 'OG003'}, {'value': '1.7', 'groupId': 'OG004'}, {'value': '1.0', 'groupId': 'OG005'}, {'value': '1.4', 'groupId': 'OG006'}]}]}, {'title': 'Stable Angina - Class III', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}, {'value': '1.3', 'groupId': 'OG003'}, {'value': '1.3', 'groupId': 'OG004'}, {'value': '1.0', 'groupId': 'OG005'}, {'value': '0.4', 'groupId': 'OG006'}]}]}, {'title': 'Stable Angina - Class IV', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}, {'value': '0.7', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.3', 'groupId': 'OG005'}, {'value': '0.4', 'groupId': 'OG006'}]}]}, {'title': 'Total Unstable Angina', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.3', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.7', 'groupId': 'OG006'}]}]}, {'title': 'Unstable Angine Class IA', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Unstable Angine Class IB', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Unstable Angine Class IC', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Unstable Angine Class IIA', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Unstable Angine Class IIB', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.7', 'groupId': 'OG006'}]}]}, {'title': 'Unstable Angine Class IIC', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Unstable Angine Class IIIA', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.3', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Unstable Angine Class IIIB', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Unstable Angine Class IIIC', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Basline, Discharge, 1, 9, 12, 24 and 36 months post-index procedure', 'description': "Evaluate the angina pectoris classification at each study visit.\n\nStable angina pectoris was classified according to the Canadian Cardiovascular Society's System: Stable Angina - Class I: normal activity does not cause angina; Stable Angina - Class II: slight limitation of normal activity, moderate exertion may cause angina; Stable Angina - Class III: marked limitation of ordinary physical activity; Stable Angina - Class IV: discomfort with any physical activity and pain may be present at rest\n\nUnstable angina pectoris was classified according to the Braunwald System: Numeral I: newly onset severe or accelerated angina with no pain at rest; Numeral II: angina at rest within the preceding month but not the past 48 hours Numeral III: angina at rest within the preceding 48 hours; Letter A: develops in presence of conditions which intensify ischemia; Letter B: develops in the absence of extracardiac conditions; Letter C: develops within 2 weeks after an acute myocardial infarction", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pro-Kinetic Energy Stent', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '329'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '287'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pro-Kinetic Energy Stent', 'description': 'PRO-Kinetic Energy Stent: Coronary artery stent implant'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'spread': '9.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '226', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '306', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '305', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '215', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Medical History', 'classes': [{'title': 'Diabetes', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '276', 'groupId': 'BG000'}]}]}, {'title': 'Hyperlipidemia', 'categories': [{'measurements': [{'value': '240', 'groupId': 'BG000'}]}]}, {'title': 'Current smoker', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}, {'title': 'Smoked within last 5 years', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': 'Never smoked or not within last 5 years', 'categories': [{'measurements': [{'value': '238', 'groupId': 'BG000'}]}]}, {'title': 'History of myocardial infarction (MI)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}]}]}, {'title': 'Prior coronary artery bypass graft (CABG)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Prior percutaneous coronary revascularization', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}, {'title': 'Renal insufficiency', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant Medications', 'classes': [{'title': 'Dual Antiplatelet Therapy (DAPT)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}, {'title': 'Aspirin', 'categories': [{'measurements': [{'value': '260', 'groupId': 'BG000'}]}]}, {'title': 'Antiplatelet - Clopidogrel', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}]}]}, {'title': 'Antiplatelet - Prasugrel', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Antiplatelet - Ticagrelor', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Antiotensin-converting-enzyme (ACE) inhibitor', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}]}]}, {'title': 'Angiotensin II receptor blocker', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}, {'title': 'Beta blocker', 'categories': [{'measurements': [{'value': '203', 'groupId': 'BG000'}]}]}, {'title': 'Statins', 'categories': [{'measurements': [{'value': '213', 'groupId': 'BG000'}]}]}, {'title': 'Insulin', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': 'Anti-coagulant', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Lesion Location', 'classes': [{'title': 'Left Anterior Descending (LAD)', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}]}]}, {'title': 'Circumflex', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}, {'title': 'Right', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Lesion Length', 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '6.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Vessel Diameter', 'classes': [{'title': 'Pre-deployment target vessel MLD', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.4', 'groupId': 'BG000'}]}]}, {'title': 'Pre-deployment target vessel reference diameter', 'categories': [{'measurements': [{'value': '2.9', 'spread': '0.5', 'groupId': 'BG000'}]}]}, {'title': 'Post-deployment target vessel MLD', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'MLD = minimal luminal diameter', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lesion Calcification', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '245', 'groupId': 'BG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Thrombolysis in Myocardial Infarction (TIMI) Flow', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '298', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'TIMI Flow is a system developed during Thrombolysis in Myocardial Infarction (TIMI) trials for grading severity of stenosis and extent of blood flow through coronary arteries; TIMI grade 0 = no perfusion; grade 1 = penetration with minimal perfusion; grade 2 = partial perfusion; grade 3 = complete perfusion. Grade 0 represents no flow beyond an occlusion, while grade 3 represents normal flow.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 329}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-31', 'studyFirstSubmitDate': '2012-06-04', 'resultsFirstSubmitDate': '2016-12-27', 'studyFirstSubmitQcDate': '2012-06-05', 'lastUpdatePostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-17', 'studyFirstPostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Vessel Failure Rate', 'timeFrame': '9 months post-index procedure', 'description': 'The primary endpoint for the Pro-Kinetic Energy Stent is the target vessel failure rate at 9-months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction and ischemia-driven target vessel revascularization.'}], 'secondaryOutcomes': [{'measure': 'Target Vessel Failure Rate', 'timeFrame': '1, 12, 24 and 36 months post-index procedure', 'description': 'Evaluate the target vessel failure rate at 1, 12, 24, and 36 months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization.'}, {'measure': 'Target Vessel Failure Rate - Contribution of Individual Event Types', 'timeFrame': '1, 12, 24 and 36 months post-index procedure', 'description': 'Contribution of each event type (cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization) to composite rate of target vessel failure.'}, {'measure': 'Overall Target Vessel Revascularization Rate', 'timeFrame': '1, 9, 12, 24 and 36 months post-index procedure', 'description': 'Evaluate the overall target vessel revascularization rate of the PRO-Kinetic Energy stent. The rate includes both ischemia-driven revascularization procedures of the target vessel, as well as revascularization procedures of the target vessel without prior clinical symptoms.'}, {'measure': 'Overall Target Lesion Failure Rate', 'timeFrame': '1, 9, 12, 24 and 36 months post-index procedure', 'description': 'Evaluate the target lesion failure rate of the PRO-Kinetic Energy stent. Target lesion failure includes cardiac death, MI, and ischemia-driven target lesion revascularization.'}, {'measure': 'Target Lesion Failure Rate - Contribution of Individual Event Types', 'timeFrame': '1, 9, 12, 24, and 36 months post-index procedure', 'description': 'The contribution of each individual event of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization to the overall rate of target lesion failure.'}, {'measure': 'Overall Target Lesion Revascularization Rate', 'timeFrame': '1, 9, 12, 24 and 36 months post-index procedure', 'description': 'Evaluate the overall target lesion revascularization rate associated with the PRO-Kinetic Energy stent. The overall target lesion revascularization rate includes both ischemia-driven revascularization procedures of the target lesion, as well as revascularization procedures of the target lesion without prior clinical symptoms.'}, {'measure': 'Composite of All-cause Mortality and All-cause MI', 'timeFrame': '1, 9, 12, 24, and 36 months post-index procedure', 'description': 'Characterize the overall safety of the PRO-Kinetic Energy stent by evaluating the composite rate of all-cause mortality and all-cause myocardial infarction.'}, {'measure': 'All-cause Mortality and All-cause MI - Contribution of Individual Rates', 'timeFrame': '1, 9, 12, 24, and 36 months post-index procedure', 'description': 'Contribution of the individual rates of mortality and myocardial infarction to the overall composite safety rate.'}, {'measure': 'Stent Thrombosis Rate', 'timeFrame': '1, 9, 12, 24 and 36 months post-index procedure', 'description': 'Evaluate the stent thrombosis rate associated with the PRO-Kinetic Energy stent. Stent thrombosis was classified according to both timing and evidence as outlined by the ARC definition of stent thrombosis. Participants were included in the evaluations at visit intervals if they had a visit at the specified interval or a thrombosis was reported at or before the visit.'}, {'measure': 'Index Procedure Success', 'timeFrame': 'Index procedure', 'description': 'Evaluate the index procedure success associated with the implant of the PR-Kinetic Energy stent. procedure success is defined as the successful delivery and deployment of the investiational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of \\< 30% by operator visual estimate without the occurrence of cardiac death, any MI (target vessel or non-target vessel) or TLR prior to hospital discharge.'}, {'measure': 'Device Success During the Index Procedure', 'timeFrame': 'Index procedure', 'description': 'Evaluate the device success associated with the implant of the PRO-Kinetic Energy stent. Device success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with standard post-dilation (if applicable) to attain a final residual stenosis of \\< 30% by operator visual estimate.'}, {'measure': 'Lesion Success During the Index Procedure', 'timeFrame': 'Index procedure', 'description': 'Evaluate the lesion success associated with the implant of the PRO-Kinetic Energy stent. Lesion success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of \\< 30% by operator visual estimate.'}, {'measure': 'Angina Pectoris Classification', 'timeFrame': 'Basline, Discharge, 1, 9, 12, 24 and 36 months post-index procedure', 'description': "Evaluate the angina pectoris classification at each study visit.\n\nStable angina pectoris was classified according to the Canadian Cardiovascular Society's System: Stable Angina - Class I: normal activity does not cause angina; Stable Angina - Class II: slight limitation of normal activity, moderate exertion may cause angina; Stable Angina - Class III: marked limitation of ordinary physical activity; Stable Angina - Class IV: discomfort with any physical activity and pain may be present at rest\n\nUnstable angina pectoris was classified according to the Braunwald System: Numeral I: newly onset severe or accelerated angina with no pain at rest; Numeral II: angina at rest within the preceding month but not the past 48 hours Numeral III: angina at rest within the preceding 48 hours; Letter A: develops in presence of conditions which intensify ischemia; Letter B: develops in the absence of extracardiac conditions; Letter C: develops within 2 weeks after an acute myocardial infarction"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['de novo coronary lesions', 'restenotic coronary lesions', 'coronary arteries'], 'conditions': ['Coronary Arteries Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the safety and efficacy of the investigational BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor a subject to be enrolled in the study and considered for the index procedure, the following initial inclusion criteria must be met:\n\n* Age ≥ 18 years\n* Willingness to comply with study follow-up requirements\n* Candidate for a percutaneous coronary intervention (PCI) procedure\n* Candidate for coronary artery bypass graft surgery\n* Documented evidence of stable or unstable angina pectoris or positive functional ischemia study (e.g. exercise treadmill test, thallium stress test, SPECT, stress echocardiogram or cardiac CT) Stable angina pectoris is defined as a documented Canadian Cardiovascular Society Classification of I, II, III or IV Unstable angina pectoris is defined as a documented Braunwald Classification of B \\& C, I, II, III\n* Written informed consent\n\nFor a subject to receive an investigational stent, the following procedure-related criteria must be met:\n\n* De novo or restenotic lesion in a native coronary artery; restenotic lesions must have been previously treated with only standard percutaneous transluminal coronary angioplasty (PTCA) (treatment must be \\> 12 months prior to the index procedure)\n* Target lesion must be in a major coronary artery (target vessel). The target vessel includes the entire territory of the left anterior descending artery, left circumflex artery or right coronary artery and any major side branch of the artery.\n* A maximum of one target lesion and one non-target lesion may be treated per subject. The lesions must be located in separate coronary arteries, with treatment of the non-target lesion occurring first using commercially available therapy (with exception of brachytherapy).\n* Lesions may be one solid lesion or a series of multiple, smaller lesions to be treated as one lesion\n* Target lesion must be treatable with a single investigational stent; an additional stent may be used when treating a vessel dissection or another similar intra-procedure complication (use of investigational stent preferred)\n* Angiographic evidence of ≥ 50% and \\< 100% stenosis (by operator visual estimate) with a TIMI flow \\> 1\n* Target lesion length of ≤ 31 mm by operator visual estimate\n* Target vessel reference diameter of 2.25 mm to 4.0 mm by operator visual estimate\n\nExclusion Criteria:\n\nFor a subject to be enrolled in the study and considered for the index procedure, the following initial exclusion criteria must not be present:\n\n* Baseline LVEF of \\< 30%; LVEF may be measured and assessed by standard-of-care echocardiography procedures within 90 days of the index procedure or by a left ventriculogram prior to the index procedure (operator visual assessment).\n* PCI in any vessel 30 days prior to the index procedure or planned for within 30 days after the index procedure\n* Stroke or transient ischemic attack within the last 6 months prior to enrollment\n* Intolerance to contrast agents that cannot be medically managed and/or intolerance to antiplatelet, anticoagulant or thrombolytic medications\n* Refusal of blood transfusions\n* Any other medical condition, that in the opinion of the investigator, poses an unacceptable risk for implant of a stent according to the study indications\n* Pregnant, planning to become pregnant or nursing during the course of the study. Women of child-bearing potential must have a negative blood pregnancy (beta hCG) test. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.\n* Known allergy to L-605 CoCr alloy (cobalt, chromium, tungsten and nickel) or amorphous silicon carbide\n* Life expectancy of less than one year\n* Participation in any other clinical investigational device or drug study.\n* Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.\n\nFor a subject to receive an investigational stent the following procedure-related criteria must not be present:\n\n* Documented diagnosis of an acute MI within 72 hours of the index procedure and an elevation of Troponin or creatine kinase-MB (CKMB) above the URL (CKMB measurement is not required if CK is normal) at the time of the index procedure (99th percentile of the individual investigative site's normal reference population)\n\n * For subjects with stable angina and elevated Troponin, CKMB \\<99% URL is required\n* ECG changes consistent with an acute MI within 72 hours of the index procedure. ECG changes consistent with an acute MI include:\n\n\\> 1 mm ST segment elevation or depression in consecutive leads New left bundle branch block (LBBB) Development of pathological Q-waves in two contiguous leads of the electrocardiogram (ECG)\n\n* Acute coronary syndrome with baseline Troponin \\> 99% URL\n* INR ≥ 1.6\n* Concomitant renal failure with serum creatinine level \\> 2.5 mg/dL\n* Unresolved neutropenia (white blood cell count \\< 3,000 / µL), thrombocytopenia (platelet count \\< 100,000 / µL) or thrombocytosis (platelet count \\> 700,000 / µL)\n* Unprotected left main coronary artery disease (CAD) (\\> 50% diameter stenosis by operator visual estimate)\n* Target vessel has been treated with any PCI procedure (e.g. PTCA, stent, cutting balloon, atherectomy, etc.) within 12 months prior to the index procedure\n* Target lesion has been treated with a stent, cutting balloon or atherectomy any time prior to the index procedure or has been treated with PTCA within 12 months prior to the index procedure\n* Target vessel treated with brachytherapy anytime prior to index procedure\n* Planned PCI in the target vessel within 9 months after the index procedure\n* Target vessel has a non-target lesion with a \\> 50% stenosis that requires treatment during the index procedure\n* Lesions preventing distal perfusion (TIMI flow 0 and 1) prior to wire crossing\n* Target lesion is in the left main coronary artery or within 2 mm of the origin of the left anterior descending artery or left circumflex artery by operator visual estimate\n* Target lesion is located within a saphenous vein graft or arterial graft\n* Target lesion involves a bifurcation - lesion is located in a major coronary artery and involves a side branch with a diameter \\> 2 mm (by operator visual estimate)\n* Presence of a complication following pre-dilatation of target lesion\n* Presence of a complication following treatment of a non-target lesion (if applicable)\n* Presence of a target vessel/lesion that has excessive tortuousity/angulation or is severely calcified preventing complete inflation of an angioplasty balloon\n* Angiographic evidence of thrombus within the target lesion\n* Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion\n* Use of cutting balloons, atherectomy or ablative devices immediately prior to investigational stent placement"}, 'identificationModule': {'nctId': 'NCT01612767', 'acronym': 'BIOHELIX-I', 'briefTitle': 'BIOHELIX-I Bare Metal Stent Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik, Inc.'}, 'officialTitle': 'The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent', 'orgStudyIdInfo': {'id': 'G110147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pro-Kinetic Energy Stent', 'interventionNames': ['Device: PRO-Kinetic Energy Stent']}], 'interventions': [{'name': 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'responsibleParty': {'type': 'SPONSOR'}}}}