Actively Recruiting
GORE TAG Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Led by W.L.Gore & Associates · Updated on 2026-06-05
125
Participants Needed
5
Research Sites
400 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the GORE4 TAG4 Thoracic Branch Endoprosthesis (TBE Device) for treating lesions in the aortic arch in Zone 0 or Zone 1. This prospective multi-center post-market study aims to collect outcomes for patients treated with the TBE Device as part of routine clinical care. The study plans to enroll at least 125 subjects across up to 50 sites in the United States to understand long-term results over several years. Participants will receive the TBE Device implantation procedure, and their progress will be followed closely. Follow-up visits are scheduled at 1 month, 6 months, 1 year, and then annually for a minimum of 5 years and up to 10 years after the procedure. The study focuses on the device's technical success, safety, and any complications related to the procedure or device over this extended period. During the study, participants will have various assessments, including monitoring for stroke, paraplegia, renal failure, lesion rupture, endoleaks, and device-related complications. Researchers will also track mortality related to the treated area and any need for additional interventions. Regular evaluations will include clinical exams and safety checks for up to 10 years. This long-term observation helps to provide important information on device performance and patient health after the procedure.
CONDITIONS
Brief Title
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or legally authorized representative provides written consent per local rules.
- Patient has been or is planned to be treated with the TBE Device in Zone 0 or Zone 1.
- Patient is 18 years of age or older at the time of consent.
You will not qualify if you...
- Patient unlikely to be available for required follow-up visits.
- Patient with exclusion criteria mandated by local laws.
- Patient currently enrolled in or planning to enroll in another investigational drug or device study within 12 months.
- Patient enrolled in another Gore study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo the GORE® TAG® Thoracic Branch Endoprosthesis implantation procedure for lesions in the aortic arch in Zone 0 or Zone 1.
1 visit (in-person)
Duration - Minimum of 5 years and up to a maximum of 10 years
Participants are followed for up to 10 years after the device implantation to monitor device performance and health outcomes.
Visits at 1 month, 6 months, 1 year, and annually thereafter
Trial Site Locations
Total: 5 locations
1
Lakeland Regional Medical Center
Lakeland, Florida, United States, 33805
Actively Recruiting
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
3
The Methodist Hospital-Houston
Houston, Texas, United States, 77030
Actively Recruiting
4
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
5
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
D
DeAnne Hart
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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