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A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION) — INNOVATION  

Abdominal Aortic Aneurysms Clinical Trial

Official title:
A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms

Clinical Trial 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.

Clinical Trial Description

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 at 7 sites in Germany and Italy. All treated subjects will be evaluated at 1 month, 3 months (if applicable), 6 and 12 months, and annually for a total of 5 years post-procedure. An interim analysis will be conducted after the 25th enrolled subject reaches the 30-day follow up visit ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01106391
Study type Interventional
Source Cordis Corporation
Contact
Status Completed
Phase N/A
Start date March 2010
Completion date October 2016
View Details
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