Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)
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).
Abdominal Aortic Aneurysm
Device: Cordis AAA Bilateral Device
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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.
|Study Start Date:||December 1999|
|Estimated Study Completion Date:||February 2006|