A MULTICENTER, OPEN LABEL, PROSPECTIVE, NON-RANDOMIZED STUDY OF INCRAFT™ IN SUBJECTS WITH ABDOMINAL AORTIC ANEURYSMS (INNOVATION) (INNOVATION)
|ClinicalTrials.gov Identifier: NCT01106391|
Recruitment Status : Completed
First Posted : April 19, 2010
Results First Posted : November 26, 2013
Last Update Posted : January 4, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysms||Device: Cordis AAA stent graft system "INCRAFT TM"||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms|
|Study Start Date :||March 2010|
|Primary Completion Date :||August 2011|
|Study Completion Date :||October 2016|
Experimental: AAA stent graft system
Abdominal aortic aneurysm stent graft system
|Device: Cordis AAA stent graft system "INCRAFT TM"|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106391
|Universitat Leipzig Herzzentrum|
|Principal Investigator:||Dierk Scheinert, PhD, MD.||Universität Leipzig - Herzzentrum|