Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT00235118
Status:
COMPLETED
Last Update Posted:
2005-12-09
First Post:
2005-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)
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': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-12'}, 'statusVerifiedDate': '2005-10', 'completionDateStruct': {'date': '2006-02'}, 'lastUpdateSubmitDate': '2005-12-08', 'studyFirstSubmitDate': '2005-10-06', 'studyFirstSubmitQcDate': '2005-10-06', 'lastUpdatePostDateStruct': {'date': '2005-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary success is defined as freedom from all of the following: rupture of aneurysm, enlargement of aneurysm > 0.5 cm on CT scan, with or without endoleak, as compared to any previous measurement, symptomatic aneurysm requiring treatment.'}, {'measure': 'The absence of major complications at thirty days defined as arterial thrombosis, respiratory impairment, renal failure, myocardial infarction (M.I.) and stroke in combination with the absence of major complications at one year.'}], 'secondaryOutcomes': [{'measure': '· Technical success defined as the successful access and deployment of the device at the appropriate anatomic location with aneurysmal exclusion determined by angiography at the time of deployment.'}]}, 'conditionsModule': {'conditions': ['Abdominal Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the safety and effectiveness of the Cordis Bilateral AAA device and its Delivery System compared to open surgical repair for the treatment of Abdominal Aortic Aneurysm (AAA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Anatomic (stent-graft)\n\nAortic Aneurysm Diameter\n\n* \\> 4.5 cm\n* Those aortic aneurysms \\< 4.5 cm that are at least 1.5 times the diameter of the aorta with a size increase of 5 mm or greater over a six month period will also be included for possible treatment.\n* Aorto-iliac aneurysms in which the aortic aneurysm is \\< 4.5 cm but the iliac artery aneurysms are \\> 3.0 cm in diameter or there is evidence of recent expansion (5 mm or greater over a six month period) in iliac aneurysms \\< 3.0 cm.\n* Saccular aortic aneurysms \\> 3.0 cm.\n\nAortic Neck\n\n* Diameter \\> 17 mm and \\< 28 mm (Phase I)\n* Diameter \\> 14 mm and \\< 28 mm (Phase II)\n\nAngulation Neck Length \\< 45° \\> 15 mm \\<60° \\> 25 mm\n\nIliac Arteries\n\n* Diameter \\> 8 mm and \\< 18 mm (Phase I and Phase II)\n* At least one common iliac artery with a cuff \\> 15 mm.\n\nDiameter Aortic Neck Common Iliac 26-28 mm 13-18 mm 23-25.9 mm 10-17 mm 20-22.9 mm 9-15 mm 17-19.9 mm 8-13 mm 14-16.9 mm 8-11mm\n\n\\*NOTE: An aortic diameter cannot be treated if the iliac diameter is not in the same range (e.g. 26-28 mm aortic necks must be in conjunction with 13-18 mm common iliacs).\n\nAnatomic (surgical controls)\n\n· Surgical controls will be required to meet only the aortic or aorto-iliac aneurysm size requirements for anatomic inclusion criteria.\n\nAortic Aneurysm Diameter\n\n* \\> 4.5 cm\n* Those aortic aneurysms \\<4.5 cm that are at least 1.5 times the diameter of the aorta with a size increase of 5 mm or greater over a six month period will also be included for possible treatment.\n* Aorto-iliac aneurysm in which the aortic aneurysm is \\<4.5 cm but the iliac artery aneurysm are \\>3.0 cm in diameter or there is evidence of recent expansion (5 mm or greater over a six month period) in iliac aneurysms \\<3.0 cm.\n* Saccular aortic aneurysms \\> 3.0 cm.\n* Clinical (stent-graft)\n* Males and non-pregnant females \\> 40 years of age.\n* Clinical (surgical controls)\n\nSurgical control patients will be required to meet all of the above-stated stent-graft clinical inclusion criteria.\n\nExclusion Criteria:\n\nAnatomic (stent-graft)\n\nAortic Aneurysm Diameter\n\n· \\< 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a size increase of 5 mm or greater within a six month period.\n\nAorto-iliac Aneurysms\n\n* \\< 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six month period).\n* The iliac portion of the aneurysm extending to the bifurcation bilaterally which would necessitate covering both internal iliac arteries with the device.\n\nAortic Neck\n\n* Diameter \\< 17 mm and \\> 28 mm (Phase I)\n* Diameter \\< 14 and \\>28 (Phase II)\n* Thrombus lined\n* Highly calcified\n\n * NOTE: See inclusion criteria for length below the renals and degree of angulation.\n\nIliac Arteries\n\n* \\< 8 mm and \\> 18 mm (native) (Phase I and Phase II)\n* Highly calcified (common)\n* Neither common iliac artery with a cuff \\> 15 mm.\n\n * NOTE: See inclusion criteria for aortic neck and iliac artery diameters.\n\nAnatomic (surgical controls)\n\n· Surgical controls will be excluded based only on the aortic or aorto-iliac aneurysm size requirements for anatomic exclusion criteria.\n\nAortic Aneurysm Diameter\n\n· \\< 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a size increase of 5 mm or greater within a six month period.\n\nAorto-Iliac Aneurysms\n\n* \\< 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six month period).\n* The iliac portion of the aneurysm extending to the bifurcation bilaterally which would necessitate surgically covering both internal iliac arteries.\n\nClinical (stent-graft)\n\n1. Ruptured abdominal aortic aneurysm.\n2. Renal insufficiency - creatinine level \\> 2.5 mg/dl.'}, 'identificationModule': {'nctId': 'NCT00235118', 'briefTitle': 'Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cordis US Corp.'}, 'officialTitle': 'An Evaluation of the Safety and Effectiveness of the Cordis Bilateral AAA Device Compared to Open Surgical Repair for the Treatment of Abdominal Aortic Aneurysm', 'orgStudyIdInfo': {'id': 'P98-4601'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cordis AAA Bilateral Device', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Michael Marin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOUNT SINAI HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cordis US Corp.', 'class': 'INDUSTRY'}}}}