Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-26 @ 9:02 PM
Study NCT ID:
NCT00196092
Status:
COMPLETED
Last Update Posted:
2015-03-12
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zenith® AAA Endovascular Graft Clinical Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D057176', 'term': 'Compassionate Use Trials'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D035703', 'term': 'Therapies, Investigational'}, {'id': 'D017277', 'term': 'Drug Approval'}, {'id': 'D000076722', 'term': 'Drug Development'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 819}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-11', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2015-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Abdominal Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac aneurysms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with an aortic or aortoiliac aneurysm with diameter greater than or equal to 4 cm.\n2. Patients with an iliac aneurysm with diameter greater than or equal to 3.5 cm.\n3. Patients with an aortic, aortoiliac, or iliac aneurysm with a history of growth greater than or equal to 0.5 cm per year.\n\nExclusion Criteria:\n\n1. Patients less than 18 years of age.\n2. Patient with a life expectancy less than 2 years.\n3. Patients who are pregnant.\n4. Patients unwilling to comply with the follow-up schedule.\n5. Patient inability or refusal to give informed consent.'}, 'identificationModule': {'nctId': 'NCT00196092', 'briefTitle': 'Zenith® AAA Endovascular Graft Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'Zenith® AAA Endovascular Graft Clinical Study', 'orgStudyIdInfo': {'id': '99-514'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Roll-in', 'interventionNames': ['Device: Roll-in']}, {'type': 'OTHER', 'label': '2', 'description': 'Surgical', 'interventionNames': ['Device: Surgical']}, {'type': 'OTHER', 'label': '3', 'description': 'Standard Risk', 'interventionNames': ['Device: Standard Risk']}, {'type': 'OTHER', 'label': '4', 'description': 'High Risk', 'interventionNames': ['Device: High Risk']}, {'type': 'OTHER', 'label': '5', 'description': 'Compassionate Use', 'interventionNames': ['Device: Compassionate Use']}, {'type': 'OTHER', 'label': '6', 'description': 'Treatment for females.', 'interventionNames': ['Device: Treatment for females']}, {'type': 'OTHER', 'label': '7', 'description': 'Standard Risk Continued Access', 'interventionNames': ['Device: Standard Risk Continued Access']}, {'type': 'OTHER', 'label': '8', 'description': 'High Risk Continued Access', 'interventionNames': ['Device: High Risk Continued Access']}], 'interventions': [{'name': 'Roll-in', 'type': 'DEVICE', 'description': 'Proctored entry.', 'armGroupLabels': ['1']}, {'name': 'Surgical', 'type': 'DEVICE', 'description': 'Surgery', 'armGroupLabels': ['2']}, {'name': 'Standard Risk', 'type': 'DEVICE', 'description': 'Standard Endovascular repair', 'armGroupLabels': ['3']}, {'name': 'High Risk', 'type': 'DEVICE', 'description': 'High Risk Endovascular repair.', 'armGroupLabels': ['4']}, {'name': 'Compassionate Use', 'type': 'DEVICE', 'description': 'Endovascular repair for compassionate use patients.', 'armGroupLabels': ['5']}, {'name': 'Treatment for females', 'type': 'DEVICE', 'description': 'Endovascular repair in female patients', 'armGroupLabels': ['6']}, {'name': 'Standard Risk Continued Access', 'type': 'DEVICE', 'description': 'Continued Access Endovascular repair for standard risk patients.', 'armGroupLabels': ['7']}, {'name': 'High Risk Continued Access', 'type': 'DEVICE', 'description': 'Continued Access Endovascular Repair for High Risk Patients.', 'armGroupLabels': ['8']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Roy Greenberg, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}}}}