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
HonorHealth
Scottsdale, Arizona 85251
Scottsdale, Arizona 85251
Keck Medical Center of USC
Los Angeles, California 90033
Los Angeles, California 90033
Hartford Hospital
Hartford, Connecticut 06102
Hartford, Connecticut 06102
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
Washington D.C., District of Columbia 20010
University of Florida Health Heart & Vascular
Gainesville, Florida 32608
Gainesville, Florida 32608
Lakeland Regional Medical Center
Lakeland, Florida 33805
Lakeland, Florida 33805
University of South Florida
Tampa, Florida 33606
Tampa, Florida 33606
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Duke University Medical Center
Durham, North Carolina 27710
Durham, North Carolina 27710
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
The Methodist Hospital-Houston
Houston, Texas 77030
Houston, Texas 77030
Baylor Scott & White Research Institute
Plano, Texas 75093
Plano, Texas 75093
Intermountain Medical Center
Murray, Utah 84107
Murray, Utah 84107
University of Washington Medical Center
Seattle, Washington 98195
Seattle, Washington 98195
University of Wisconsin - Madison
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
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.