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