Clinical Trial: GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Clinical Evaluation of the GORE EXCLUDER® Bifurcated Endoprosthesis - Low Permeability in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms

Brief Summary: The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.

Detailed Summary:
Sponsor: W.L.Gore & Associates

Current Primary Outcome: Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure [ Time Frame: 2 years ]

Original Primary Outcome: Incidence of aneurysm volume increase greater than 10% as compared to the 1-month baseline from to the original GORE EXCLUDER® through 2 years post-procedure [ Time Frame: 2 years ]

Current Secondary Outcome: Device Efficacy Events [ Time Frame: 2 years ]

Original Secondary Outcome: Same as current

Information By: W.L.Gore & Associates

Dates:
Date Received: December 20, 2007
Date Started: June 2005
Date Completion:
Last Updated: July 13, 2010
Last Verified: July 2010