Clinical Trial: GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta

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

Official Title: Evaluation of the GORE TAG® Thoracic Endoprosthesis - 45 mm for the Primary Treatment of Aneurysms of the Descending Thoracic Aorta

Brief Summary: The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.

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

Current Primary Outcome: Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment [ Time Frame: one year ]

Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: W.L.Gore & Associates

Dates:
Date Received: December 20, 2007
Date Started: February 2007
Date Completion:
Last Updated: March 4, 2015
Last Verified: March 2015