A Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms (INNOVATION)
This study is a multi-center prospective, open label, non-randomized investigation of INCRAFT™ in subjects with abdominal aortic aneurysms.
The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy.
Abdominal Aortic Aneurysms
Device: Cordis AAA stent graft system "INCRAFT TM"
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms|
- Technical success will be defined by the successful deployment of the stent-graft to the desired location in the absence of Types I, III or IV endoleaks at the conclusion of the procedure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Safety will be defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events (death, MI, stroke and renal failure) within 1 month post-procedure. [ Time Frame: 1 month follow-up ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||June 2016|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: AAA stent graft system
AAA stent graft system
|Device: Cordis AAA stent graft system "INCRAFT TM"|