Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-02-11 @ 12:36 PM
Study NCT ID:
NCT00530504
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2007-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephanie.a.cihlar@medtronic.com', 'phone': '763-398-7932', 'title': 'Stephanie Cihlar', 'organization': 'Medtronic'}, 'certainAgreement': {'otherDetails': "There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results without permission of the sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 Days', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.', 'otherNumAtRisk': 1500, 'otherNumAffected': 258, 'seriousNumAtRisk': 1500, 'seriousNumAffected': 553}], 'otherEvents': [{'term': 'Blood And Lymphatic System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Ear And Labyrinth Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Eye Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Gastrointestinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 27, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'General Disorders And Administrative Site Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 41, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Hepatobiliary Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Immune System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Infections And Infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 47, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Injury, Poisoning And Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Metabolism And Nutrition Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Musculoskeletal And Connective Tissue Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 35, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Nervous System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 46, 'numAffected': 44}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Psychiatric Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Renal And Urinary Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Reproductive System And Breast Disoders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Respiratory, Thoracic And Mediastinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 27, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Skin And Subcutaneous Tissue Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Surgical And Medical Procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vascular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'seriousEvents': [{'term': 'Blood And Lymphatic System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 34, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 117, 'numAffected': 98}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Ear And Labyrinth Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 42, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'General Disorders And Administrative Site Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 76, 'numAffected': 71}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Hepatobiliary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Immune System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Infections And Infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 51, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Injury, Poisoning And Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Metabolism And Nutrition Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Musculoskeletal And Connective Tissue Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Nervous System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 150, 'numAffected': 142}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Psychiatric Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Renal And Urinary Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Respiratory, Thoracic And Mediastinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 33, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Skin And Subcutaneous Tissue Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Surgical And Medical Procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vascular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1500, 'numEvents': 284, 'numAffected': 268}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1500', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stent and Protection Device', 'description': 'PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1500'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1348'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'Exited study due to other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1500', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'spread': '9.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '577', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '923', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2007-09-14', 'resultsFirstSubmitDate': '2015-07-28', 'studyFirstSubmitQcDate': '2007-09-14', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-08-14', 'studyFirstPostDateStruct': {'date': '2007-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.', 'timeFrame': '30 Days', 'description': 'Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Carotid Artery Disease', 'Embolic Protection'], 'conditions': ['Carotid Artery Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ev3.net', 'label': 'Click here for information on ev3 Endovascular Inc.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are:\n\n1. To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device.\n2. To evaluate rare and unanticipated adverse events.\n3. To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and above\n* Informed consent\n* Intent to use the PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX and SpiderFX™ to treat carotid artery disease per Instructions for Use\n* Meet Instruction for Use (IFU)/ Centers for Medicare \\& Medicaid Services (CMS)defined anatomical or clinical high risk criteria\n\nExclusion Criteria:\n\n* Subjects with contraindications as outlined in the Instructions for Use'}, 'identificationModule': {'nctId': 'NCT00530504', 'acronym': 'CREATE PAS', 'briefTitle': 'Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Endovascular'}, 'officialTitle': 'Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study', 'orgStudyIdInfo': {'id': 'P-2611'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device', 'description': 'Device', 'interventionNames': ['Device: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device']}], 'interventions': [{'name': 'PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device', 'type': 'DEVICE', 'description': 'Carotid artery stenting with distal embolic protection.', 'armGroupLabels': ['Device']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Hospital', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Wellmont Medical Center', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}], 'overallOfficials': [{'name': 'Gary Ansel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MidWest Cardiology Research Foundation'}, {'name': 'Robert Safian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Endovascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}