Trials / Active Not Recruiting
Active Not RecruitingNCT03728985
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- W.L.Gore & Associates · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, non-randomized, , multicenter study with two independent arms: * Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. * Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only * Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis. Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis | Endovascular Aortic Stent-Graft |
Timeline
- Start date
- 2019-06-17
- Primary completion
- 2023-01-04
- Completion
- 2030-01-01
- First posted
- 2018-11-02
- Last updated
- 2026-02-27
- Results posted
- 2024-08-05
Locations
44 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03728985. Inclusion in this directory is not an endorsement.