A MULTICENTER, OPEN LABEL, PROSPECTIVE, NON-RANDOMIZED STUDY OF INCRAFT™ IN SUBJECTS WITH ABDOMINAL AORTIC ANEURYSMS (INNOVATION) (INNOVATION)
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|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|
|Actual Primary Completion Date :||August 2011|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|