GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
NCT07166133 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2026-05-14
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.
Conditions
- Aortic Arch Dissection
- Aortic Arch Aneurysm
Interventions
- DEVICE
-
GORE® TAG® Thoracic Branch Endoprosthesis
Lesions in aortic arch in Zone 0 or Zone 1
Sponsors & Collaborators
-
W.L.Gore & Associates
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-02
- Primary Completion
- 2028-07-31
- Completion
- 2036-03-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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