A MULTICENTER, OPEN LABEL, PROSPECTIVE, NON-RANDOMIZED 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|
- Rate of Technical Success Through the One Month Follow up. [ Time Frame: From procedure to one month follow up ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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.
|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
Abdominal aortic aneurysm stent graft system
|Device: Cordis AAA stent graft system "INCRAFT TM"|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106391
|Universitat Leipzig Herzzentrum|
|Principal Investigator:||Dierk Scheinert, PhD, MD.||Universität Leipzig - Herzzentrum|