Viewing Study NCT02513303

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Ignite Creation Date: 2025-12-24 @ 7:36 PM
Ignite Modification Date: 2025-12-29 @ 7:27 PM
Study NCT ID: NCT02513303
Status: COMPLETED
Last Update Posted: 2025-10-09
First Post: 2015-07-29
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D001164', 'term': 'Arteriovenous Fistula'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rakesh@vasculartx.com', 'phone': '9176204369', 'title': 'Rakesh Raghubanshi', 'organization': 'Vascular Therapies, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.', 'eventGroups': [{'id': 'EG000', 'title': 'Sirogen', 'description': 'Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 115, 'seriousNumAtRisk': 127, 'deathsNumAffected': 8, 'seriousNumAffected': 56}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants underwent AV fistula surgery without an implant', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 101, 'seriousNumAtRisk': 116, 'deathsNumAffected': 4, 'seriousNumAffected': 55}, {'id': 'EG002', 'title': 'Run-in', 'description': 'Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery. The first subject enrolled by a participating surgeon was a run-in subject; run-in subjects were part of the randomized set; all run-in subjects receive Sirogen.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 24, 'seriousNumAtRisk': 26, 'deathsNumAffected': 2, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arteriovenous fistula occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arteriovenous fistula site complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arteriovenous fistula thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemodialysis complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemodialysis-induced symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary ostial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nodal rhythm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Biliary tract disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 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encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Uraemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 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'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Orthopnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Refusal of treatment by patient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial septal defect repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Steal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fistula Suitability for Dialysis at 6 Months (FSD6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirogen', 'description': 'Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants underwent AV fistula surgery without an implant'}, {'id': 'OG002', 'title': 'Run-in', 'description': 'Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery. The first subject enrolled by a participating surgeon was a run-in subject; run-in subjects were part of the randomized set; all run-in subjects receive Sirogen.'}], 'classes': [{'categories': [{'title': 'Met FSD6 criteria', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}, {'title': 'Did not meet FSD6 criteria', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Indeterminant FSD6', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2942', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'For subjects who are on hemodialysis by day 150, suitability for dialysis will be determined by the ability to use the fistula for dialysis using 2-needles with a mean dialysis machine blood pump speed of ≥300 mL/min for two-thirds of the dialysis sessions during a 30 day suitability ascertainment period that begins 150 days after fistula creation.\n\nFor subjects who are not on hemodialysis on day of enrollment and who do not initiate hemodialysis by day 150, suitability for dialysis will be determined by a vascular ultrasound performed at the 6 month follow up visit. Suitability for dialysis will be defined as a fistula with an access vein diameter (AVD) of ≥6 mm (internal diameter) and an access blood flow of ≥500 mL/min.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sirogen', 'description': 'Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery'}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants underwent AV fistula surgery without an implant'}, {'id': 'FG002', 'title': 'Run-in', 'description': 'Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery. The first subject enrolled by a participating surgeon was a run-in subject; run-in subjects were part of the randomized set; all run-in subjects receive Sirogen.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '101'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '269', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sirogen', 'description': 'Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery'}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants underwent AV fistula surgery without an implant'}, {'id': 'BG002', 'title': 'Run-in', 'description': 'Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery. The first subject enrolled by a participating surgeon was a run-in subject; run-in subjects were part of the randomized set; all run-in subjects receive Sirogen.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '169', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'spread': '14.9', 'groupId': 'BG000'}, {'value': '57.7', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '17.3', 'groupId': 'BG002'}, {'value': '59.0', 'spread': '14.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '212', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '269', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Kidney Disease Status at Enrollment', 'classes': [{'categories': [{'title': 'Chronic kidney disease', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}, {'title': 'End stage renal disease', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '199', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-22', 'size': 958408, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-18T14:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 269}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2021-07-11', 'completionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2015-07-29', 'dispFirstSubmitQcDate': '2021-07-15', 'resultsFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2015-07-29', 'dispFirstPostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-22', 'studyFirstPostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fistula Suitability for Dialysis at 6 Months (FSD6)', 'timeFrame': '6 months', 'description': 'For subjects who are on hemodialysis by day 150, suitability for dialysis will be determined by the ability to use the fistula for dialysis using 2-needles with a mean dialysis machine blood pump speed of ≥300 mL/min for two-thirds of the dialysis sessions during a 30 day suitability ascertainment period that begins 150 days after fistula creation.\n\nFor subjects who are not on hemodialysis on day of enrollment and who do not initiate hemodialysis by day 150, suitability for dialysis will be determined by a vascular ultrasound performed at the 6 month follow up visit. Suitability for dialysis will be defined as a fistula with an access vein diameter (AVD) of ≥6 mm (internal diameter) and an access blood flow of ≥500 mL/min.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dialysis', 'End Stage Renal Disease', 'End Stage Kidney Disease', 'ESRD', 'Chronic Kidney Failure', 'Chronic Renal Failure', 'Chronic Kidney Disease', 'Hemodialysis', 'Vascular Access', 'Arteriovenous Fistula', 'AV Fistula', 'AVF', 'Nephrology', 'Vascular Surgery', 'Dialysis Access'], 'conditions': ['Complication of Renal Dialysis', 'End Stage Renal Disease', 'End Stage Kidney Disease', 'ESRD', 'Chronic Kidney Failure', 'Complication of Hemodialysis', 'Vascular Access Complication', 'Arteriovenous Fistula']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure).', 'detailedDescription': 'The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure). Following successful creation of the AV fistula, the cohort randomized to the treatment group will receive the SeCI; the control group will not receive an implant. The primary hypothesis is that the proportion of subjects that meet requirements for fistula suitability for dialysis six months following the index procedure will be higher in the treatment group in comparison to the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently on hemodialysis for ≤12 months or expected to initiate hemodialysis within approximately 6 months of the creation of the AV fistula.\n* Vascular anatomy suitable for creation of the AV fistula, determined by pre procedure duplex ultrasound\n* Successful creation of a single stage radiocephalic or brachiocephalic end to side fistula\n\nExclusion Criteria:\n\n* Prior AV access created on the limb where the fistula surgery is planned\n* ST-elevation MI or cerebrovascular accident within 30 days of the index procedure\n* Known hypersensitivity to the following: sirolimus, beef or bovine collagen\n* Hypotension with systolic blood pressures \\<100 mm Hg at the time of screening\n* Known or suspected active infection at the time of the AV fistula surgery\n* Known to be HIV positive\n* Prisoner, mentally incompetent, and/or alcohol or drug abuser'}, 'identificationModule': {'nctId': 'NCT02513303', 'acronym': 'ACCESS', 'briefTitle': 'Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vascular Therapies, Inc.'}, 'officialTitle': 'A Phase 3, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus-Eluting Collagen Implant', 'orgStudyIdInfo': {'id': 'VT-304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'AV fistula surgery Single administration of sirolimus-eluting Collagen implant', 'interventionNames': ['Drug: Sirolimus', 'Procedure: AV Fistula Surgery', 'Device: Sirolimus-eluting Collagen Implant (SeCI)']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'AV fistula surgery', 'interventionNames': ['Procedure: AV Fistula Surgery']}], 'interventions': [{'name': 'Sirolimus', 'type': 'DRUG', 'otherNames': ['Rapamycin'], 'description': 'A single dose of sirolimus delivered locally', 'armGroupLabels': ['Treatment Group']}, {'name': 'AV Fistula Surgery', 'type': 'PROCEDURE', 'description': 'AV Fistula Surgery', 'armGroupLabels': ['Control Group', 'Treatment Group']}, {'name': 'Sirolimus-eluting Collagen Implant (SeCI)', 'type': 'DEVICE', 'otherNames': ['Rapamycin'], 'description': 'SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Nephrology Consultants, LLC', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'AKDHC Medical Research Service', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Institute of Medical Research', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '18017', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Northeast Clinical Research Center', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}], 'overallOfficials': [{'name': 'Sriram Iyer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vascular Therapies, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vascular Therapies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}