Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)
|ClinicalTrials.gov Identifier: NCT00235118|
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : December 9, 2005
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysm||Device: Cordis AAA Bilateral Device||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 1999|
|Estimated Study Completion Date :||February 2006|
- 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.
- 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.
- · 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235118
|United States, New York|
|Mt. Sinai Hospital|
|New York, New York, United States, 10029|
|Principal Investigator:||Michael Marin, MD||Mt Sinai Hospital, Chicago|