GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study

Recruiting now · Not applicable

Conditions studied: Aortic Arch Dissection, Aortic Arch Aneurysm

In brief

A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice.

Key facts

Study ID

NCT07166133

Run by

W.L.Gore & Associates

People needed

125

Starts

2026-03-02

Expected to finish

2036-03-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.
• Patient has been or is intended to be treated with the TBE Device in Zone 0 or Zone 1.
• Patient is age ≥ 18 years at time of informed consent signature.

You may not qualify if…

• Patient who is, at the time of consent, unlikely to be available for defined follow-up visits.
• Patient with exclusion criteria required by local law.
• Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or investigational device study within 12 months of study enrollment. Subjects cannot be enrolled in another Gore study.

Where it is running

• Keck Medical Center of USC — Los Angeles, California, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• University of Florida Health Heart & Vascular — Gainesville, Florida, United States (enrolling)
• Lakeland Regional Medical Center — Lakeland, Florida, United States (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• The Methodist Hospital-Houston — Houston, Texas, United States (enrolling)
• Baylor Scott & White Research Institute — Plano, Texas, United States (enrolling)
• Intermountain Medical Center — Murray, Utah, United States (enrolling)
• University of Washington Medical Center — Seattle, Washington, United States (enrolling)
• University of Wisconsin - Madison — Madison, Wisconsin, United States (enrolling)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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