Clinical Trial: Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms

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

Official Title: A Clinical Evaluation of the GORE TAG Thoracic Endoprosthesis in the Primary Treatment of Descending Thoracic Aortic Aneurysms

Brief Summary: The purpose of this post-approval study is to evaluate the long-term performance of the GORE TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic aortic (DTA) aneurysms

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

Current Primary Outcome: Aneurysm Related Death [ Time Frame: 5 years ]

Freedom from aneurysm related mortality for TAG 05-02 subjects


Original Primary Outcome: Aneurysm Related Death [ Time Frame: 5 years ]

Current Secondary Outcome: A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair. [ Time Frame: 5 years ]

Proportion of subjects in TAG 05-02 with MAEs


Original Secondary Outcome: A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair. [ Time Frame: 5 years ]

Information By: W.L.Gore & Associates

Dates:
Date Received: December 20, 2007
Date Started: August 2005
Date Completion:
Last Updated: August 6, 2014
Last Verified: August 2014