Trials / Approved For Marketing
Approved For MarketingNCT05442489
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)
Evaluation of the GORE® EXCLUDER® Thoracoabdominal BranchTreatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- W.L.Gore & Associates · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- —
Summary
Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms.
Detailed description
Gore will permit the use of the TAMBE Device in a manner consistent with the approved CIP provided that its use is needed to treat a serious, but non-life-threatening condition. In the requesting physician's opinion, there must be no acceptable alternative treatment option. Patients are to be consented with an Emergency / Compassionate Use ICF template provided by Gore upon request for this type of device use. Sites will be required to fill out a packet justifying the rationale of use as well as their plan to conduct follow-up surveillance on the non-study subject. Upon performance of the case, the site will immediately notify Gore and provide supporting documentation to facilitate timely, compliant regulatory reporting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GORE Excluder Thoracoabdominal Branch Endoprosthesis | TEVAR |
Timeline
- First posted
- 2022-07-05
- Last updated
- 2026-02-18
Locations
41 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05442489. Inclusion in this directory is not an endorsement.