Status:
NOT_YET_RECRUITING
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Aortic Arch Dissection
Aortic Arch Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 clin...
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 thereaft...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2036
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT07166133
Start Date
March 1 2026
End Date
March 1 2036
Last Update
September 17 2025
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