Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT01424267
Status:
TERMINATED
Last Update Posted:
2012-10-11
First Post:
2011-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zenith® LP Abdominal Aortic Aneurysm (AAA) Post-Market Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], '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': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'whyStopped': 'The registry was discontinued due to significant resources required.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-10', 'studyFirstSubmitDate': '2011-08-23', 'studyFirstSubmitQcDate': '2011-08-25', 'lastUpdatePostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'graft patency and aneurysm exclusion', 'timeFrame': 'during (day 1) and after implantation through 12 months'}]}, 'conditionsModule': {'keywords': ['low profile', 'endovascular graft', 'endovascular procedure', 'aortic aneurysm, abdominal aortic aneurysm'], 'conditions': ['Abdominal Aortic Aneurysm', 'Aorto-iliac Aneurysm']}, 'descriptionModule': {'briefSummary': 'A registry to collect additional prospective intra-operative and follow-up information on physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft under routine clinical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients implanted with a CE-Marked Zenith® Low Profile AAA Endovascular Graft', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is implanted with Zenith® Low Profile AAA Endovascular Graft\n\nExclusion Criteria:\n\n* Patients for whom this device would not normally be considered standard of care.'}, 'identificationModule': {'nctId': 'NCT01424267', 'briefTitle': 'Zenith® LP Abdominal Aortic Aneurysm (AAA) Post-Market Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'Zenith® LP AAA Endovascular Graft Post-Market Registry', 'orgStudyIdInfo': {'id': '10-006'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'interventionNames': ['Device: Zenith® Low Profile AAA Endovascular Graft']}], 'interventions': [{'name': 'Zenith® Low Profile AAA Endovascular Graft', 'type': 'DEVICE', 'description': 'Treatment of an abdominal aortic or aorto-iliac aneurysm with the CE-marked Zenith(R) Low Profile AAA Endovascular Graft.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH (General Hospital Vienna)', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'UHZ Hamburg GmbH (Eppendorf University Hospital)', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar (RDI Munich)', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Klinikum Nürnberg Süd', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'city': 'Belfast', 'country': 'Ireland', 'facility': 'Royal Victoria Hospital'}, {'city': 'Modena', 'country': 'Italy', 'facility': "Nuovo Ospendale Civile Sant' Agostino Estense di Baggiovara", 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Azoemda ospedaliera San Camillo Forlanini', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'St. Olav University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St. Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St. Mary's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Informary', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'city': 'Wales', 'country': 'United Kingdom', 'facility': 'Royal Gwent Hospital', 'geoPoint': {'lat': 53.34061, 'lon': -1.28162}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}