Clinical Trial: Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 0/1)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta

Brief Summary: The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.

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

Current Primary Outcome: Composite of Initiation of Index Procedure, Device Technical Success and Adverse Events for Zone 0/1 Subjects (Aneurysm Cohort) [ Time Frame: 1 month ]

Composite of the following events through one month: initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure and absence of the following Core Lab and adverse events: aortic rupture, lesion related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: W.L.Gore & Associates

Dates:
Date Received: May 12, 2016
Date Started: August 2016
Date Completion: July 2024
Last Updated: May 3, 2017
Last Verified: May 2017