GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Purpose
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.
Conditions
- Aortic Arch Dissection
- Aortic Arch Aneurysm
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- GORE® TAG® Thoracic Branch Endoprosthesis (TBE)
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) |
|
Recruiting Locations
Lakeland Regional Medical Center
Lakeland, Florida 33805
Lakeland, Florida 33805
University of Washington Medical Center
Seattle, Washington 98195
Seattle, Washington 98195
More Details
- Status
- Recruiting
- Sponsor
- W.L.Gore & Associates
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 thereafter for a minimum of 5-years and up to a maximum of 10 years.