A Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms (INNOVATION)
This trial is active, not recruiting.
|Condition||abdominal aortic aneurysms|
|Treatment||cordis aaa stent graft system "incraft tm"|
|Start date||March 2010|
|End date||August 2011|
|Trial size||60 participants|
|Trial identifier||NCT01106391, EE09-01|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
AAA stent graft system
Rate of Technical Success Through the One Month Follow up.
time frame: From procedure to one month follow up
Rate of Primary Safety Endpoint Within 1 Month Post-procedure.
time frame: One month follow-up
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Subject understands study requirements and treatment procedures and agrees to sign an informed consent form prior to any study procedures. 2. Subject is considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm. The INCRAFT Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta having vascular morphology suitable for endovascular repair, including: 1. Adequate iliac/femoral access compatible with the required delivery systems 2. Non-aneurysmal proximal aortic neck, and 3. Non-aneurysmal distal iliac landing zone.
|Official title||A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms|
|Principal investigator||Dierk Scheinert, PhD, MD.|
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