RecruitingNot ApplicableNCT07166133

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

Sponsor

W.L.Gore & Associates

Enrollment

125 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

Aortic Arch Aneurysm Aortic Arch Dissection

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria2

Patient who is, at the time of consent, unlikely to be available for defined follow-up visits.
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.

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