Clinical Trial: A MULTICENTER, OPEN LABEL, PROSPECTIVE, NON-RANDOMIZED STUDY OF INCRAFT™ IN SUBJECTS WITH ABDOMINAL AORTIC ANEURYSMS (INNOVATION)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms
Brief Summary:
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.
Detailed Summary:
Sponsor: Cordis Corporation
Current Primary Outcome:
- Rate of Technical Success Through the One Month Follow up. [ Time Frame: From procedure to one month follow up ]Technical success is defined as 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 and through the one month follow up.
- Rate of Primary Safety Endpoint Within 1 Month Post-procedure. [ Time Frame: One month follow-up ]Primary safety is defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events within 1 month post-procedure. Major adverse events include death, MI, stroke and renal failure.
Original Primary Outcome:
- 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 ]
- Safety will be defined by the absence of device and/or procedural related Types I, III or IV endoleaks and major adverse events (death, MI, stroke and renal failure) within 1 month post-procedure. [ Time Frame: 1 month follow-up ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Cordis Corporation
Dates:
Date Received: April 16, 2010
Date Started: March 2010
Date Completion:
Last Updated: November 16, 2016
Last Verified: November 2016