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Recruiting
NCT07166133
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Conditions: Aortic Arch Dissection, Aortic Arch Aneurysm
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 125
Sponsor: W.L.Gore & Associates
Location: Keck Medical Center of USC Los Angeles California
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07166133). StuddyBuddy aggregates publicly available trial information.