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