Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT00893620
Status:
TERMINATED
Last Update Posted:
2017-02-14
First Post:
2009-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zenith(R) Connection Endovascular Covered Stent Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017543', 'term': 'Iliac Aneurysm'}], 'ancestors': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Due to less than expected enrollment rates, Cook has reevaluated the need for this clinical study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-13', 'studyFirstSubmitDate': '2009-04-27', 'studyFirstSubmitQcDate': '2009-05-04', 'lastUpdatePostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Deployment and procedural outcome', 'timeFrame': '30 days'}]}, 'conditionsModule': {'keywords': ['iliac aneurysm', 'endovascular repair'], 'conditions': ['Aorto-iliac Aneurysms', 'Iliac Aneurysms']}, 'descriptionModule': {'briefSummary': 'The Zenith(R) Connection Endovascular Covered Stent Clinical Study is a clinical investigation to study the safety and performance of the Zenith(R) Connection Endovascular Covered Stent in conjunction with the Zenith(R) Branch Endovascular Graft-Iliac Bifurcation in the treatment of aorto-iliac and iliac aneurysms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An aortoiliac or iliac aneurysm of appropriate size\n* Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Inability or refusal to give informed consent\n* Disease considerations that would compromise patient safety or study outcomes\n* Unsuitable arterial anatomy'}, 'identificationModule': {'nctId': 'NCT00893620', 'briefTitle': 'Zenith(R) Connection Endovascular Covered Stent Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'orgStudyIdInfo': {'id': '08-007'}, 'secondaryIdInfos': [{'id': '370020, BVCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Treatment', 'interventionNames': ['Device: Zenith(R) Connection Endovascular Covered Stent with the Zenith® Branch Endovascular Graft-Iliac Bifurcation and Zenith Flex(R) AAA Endovascular Graft']}], 'interventions': [{'name': 'Zenith(R) Connection Endovascular Covered Stent with the Zenith® Branch Endovascular Graft-Iliac Bifurcation and Zenith Flex(R) AAA Endovascular Graft', 'type': 'DEVICE', 'otherNames': ['Zenith(R) Connection Endovascular Covered Stent'], 'description': 'These devices will be used in patients with an unsuitable distal sealing site for the standard Zenith(R) iliac leg component proximal to the common iliac bifurcation to maintain internal iliac artery patency with endovascular aneurysm repair.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49808', 'city': 'Lingen', 'country': 'Germany', 'facility': 'St. Bonifatius Hospital GmbH', 'geoPoint': {'lat': 52.52143, 'lon': 7.31845}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'St. Franziskus Hospital', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Infirmary', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Anthony Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christine E. Lynn Heart and Vascular Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}