GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
W.L.Gore & Associates
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.
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 thereafter for a minimum of 5-years and up to a maximum of 10 years.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 an…
Interventions
- DeviceGORE® TAG® Thoracic Branch Endoprosthesis
Lesions in aortic arch in Zone 0 or Zone 1
Location
- Lakeland Regional Medical CenterLakeland, Florida