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NCT07166133From ClinicalTrials.govRecruiting

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

  • Aortic Arch Dissection
  • Aortic Arch Aneurysm

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
W.L.Gore & Associates
Enrolment target
125
Started
2 March 2026
Main results due
July 2028
Study sites
19
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

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

Exclusion Criteria:

1. Patient who is, at the time of consent, unlikely to be available for defined follow-up visits.
2. Patient with exclusion criteria required by local law.
3. 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(19)

  • HonorHealth

    Scottsdale, Arizona, United States

    Recruiting

  • Keck Medical Center of USC

    Los Angeles, California, United States

    Recruiting

  • University of California Davis Health System

    Sacramento, California, United States

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, United States

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, United States

    Recruiting

  • University of Florida Health Heart & Vascular

    Gainesville, Florida, United States

    Recruiting

  • Lakeland Regional Medical Center

    Lakeland, Florida, United States

    Recruiting

  • University of South Florida

    Tampa, Florida, United States

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, United States

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, United States

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, United States

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, United States

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, United States

    Recruiting

  • The Methodist Hospital-Houston

    Houston, Texas, United States

    Recruiting

  • Baylor Scott & White Research Institute

    Plano, Texas, United States

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, United States

    Recruiting

  • University of Washington Medical Center

    Seattle, Washington, United States

    Recruiting

  • University of Wisconsin - Madison

    Madison, Wisconsin, United States

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, United States

    Recruiting

Showing 19 of 19 sites. 19 of the 19 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07166133. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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