Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-01 @ 7:30 AM
Study NCT ID:
NCT02557659
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2018-03-12
First Post:
2015-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zenith® Low Profile AAA Endovascular Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D017543', 'term': 'Iliac Aneurysm'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'nPtrsToThisExpAccNctId': 1}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2018-03', 'lastUpdateSubmitDate': '2018-03-08', 'studyFirstSubmitDate': '2015-09-22', 'studyFirstSubmitQcDate': '2015-09-22', 'lastUpdatePostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Low Profile', 'Abdominal Aortic Aneurysms', 'Endovascular'], 'conditions': ['Abdominal Aortic Aneurysms', 'Iliac Aneurysms', 'Aorto-iliac Aneurysms']}, 'descriptionModule': {'briefSummary': 'This extended investigation is to provide continued physician access to the device and collect confirmatory safety and effectiveness data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n•Subject has at least one of the following\n\n* Aortic or aortoiliac aneurysm\n* Iliac aneurysm\n* Aneurysm with a history of growth\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Inability or refusal to give informed consent\n* Life expectancy less than 2 years\n* Pregnant of breastfeeding or planning on becoming pregnant with 60 months\n* Unwilling to comply with the follow-up schedule'}, 'identificationModule': {'nctId': 'NCT02557659', 'briefTitle': 'Zenith® Low Profile AAA Endovascular Graft', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'Clinical Investigation Plan for the Zenith® Low Profile AAA Endovascular Graft', 'orgStudyIdInfo': {'id': '08-013 CA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Zenith Low Profile AAA Endovascular Graft', 'type': 'DEVICE', 'description': 'Treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143-001', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco-VA', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical School', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetss General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes-Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07960-6095', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Memorial Hospital', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University - Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital - Cornell', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065-4870', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian - Columbia', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Health Research Institute', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington-Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Aurora Saint Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Ronald Fairman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}