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NCT07166133NARecruiting

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

W.L.Gore & Associates

Start Date

3/2/2026

Completion Date

3/1/2036

Summary

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.

Detailed Description

Minimum of 125 total subjects with a TBE Device implantation procedure initiated in up to 50 Sites in the United States. Subjects will have follow-up at 1 Month, 6 Month, 1 Year, and annually thereafter for a minimum of 5-years and up to a maximum of 10 years.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

GORE® TAG® Thoracic Branch Endoprosthesis

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Conditions

Aortic Arch DissectionAortic Arch Aneurysm

Locations

Keck Medical Center of USC

Los Angeles, California 90033

United States

Hartford Hospital

Hartford, Connecticut 06102

United States

University of Florida Health Heart & Vascular

Gainesville, Florida 32608

United States

Lakeland Regional Medical Center

Lakeland, Florida 33805

United States

University of South Florida

Tampa, Florida 33606

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

The Methodist Hospital-Houston

Houston, Texas 77030

United States

Baylor Scott & White Research Institute

Plano, Texas 75093

United States

Intermountain Medical Center

Murray, Utah 84107

United States

University of Washington Medical Center

Seattle, Washington 98195

United States

University of Wisconsin - Madison

Madison, Wisconsin 53792

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States