Clinical Trial: Feasibility Study for GORE® TAG® Thoracic Branch Endoprosthesis to Treat Proximal Descending Thoracic Aortic Aneurysms

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis in the Treatment of Proximal Descending Thoracic Aortic Aneurysms

Brief Summary: The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta (DTA)

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

Current Primary Outcome:

  • Successful access Study Device [ Time Frame: During treatment procedure (day 0) ]
  • Successful deployment of Study Device [ Time Frame: During treatment procedure (day 0) ]
  • Primary Procedural Side branch patency as assessed by angiography [ Time Frame: At conclusion of the treatment procedure (day 0) ]


Original Primary Outcome:

Current Secondary Outcome:

  • 1 month side branch primary patency assessed by an independent Core Lab [ Time Frame: 1 month post procedure ]
  • 1 month device related endoleaks assessed by an independent Core Lab [ Time Frame: 1 month post procedure ]


Original Secondary Outcome:

Information By: W.L.Gore & Associates

Dates:
Date Received: December 13, 2013
Date Started: December 2013
Date Completion: June 2021
Last Updated: May 8, 2017
Last Verified: May 2017