Clinical Trial: Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms

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

Official Title: A Clinical Study Evaluating the Use of the GORE EXCLUDER® AAA Endoprosthesis - 31mm In the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms

Brief Summary: The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER® AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms

Detailed Summary: The primary objective of this study was to estimate the safety of the 31 mm GORE EXCLUDER® AAA Endoprosthesis as compared to open surgical repair when used in the treatment of infrarenal abdominal aortic aneurysms. A secondary objective was to compare device performance of the original GORE EXCLUDER® AAA Endoprosthesis to the 31mm EXCLUDER when used in the treatment of infrarenal abdominal aortic aneurysms.
Sponsor: W.L.Gore & Associates

Current Primary Outcome: Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year [ Time Frame: Treatment through 1 year post-procedure (365 days) ]

Original Primary Outcome:

Current Secondary Outcome: Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications [ Time Frame: Treatment through 1 year window post-procedure (through end of 1 year window, 546 days) ]

Original Secondary Outcome:

Information By: W.L.Gore & Associates

Dates:
Date Received: December 20, 2007
Date Started: May 2006
Date Completion:
Last Updated: March 23, 2015
Last Verified: March 2015