Thoracoabdominal Aneurysm Clinical Trial
Official title:
Evaluation of the GORE® EXCLUDER® Thoracoabdominal BranchTreatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)
Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03295682 -
Registry in Patients With Thoracoabdominal Aneurysms
|
||
| Not yet recruiting |
NCT05531084 -
Safety and Effectiveness of Surgeon-Modified Stent Grafts forTreatment of Complex Aortic Aneurysms
|
N/A | |
| Completed |
NCT03342755 -
Evaluation of STaged Endovascular Aneurysm Repair in the Management of Thoracoabdominal Pathology by Means of Branched and Fenestrated Devices.(STEAR)
|
||
| Completed |
NCT04689139 -
Biomarkers in Thoracic Aorta Surgery
|
N/A | |
| Recruiting |
NCT03074487 -
Evaluating Monitoring Techniques for Postoperative Spinal Cord Ischemia
|
||
| Completed |
NCT00583050 -
Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts
|
N/A | |
| Recruiting |
NCT03111459 -
Repair of Thoracoabdominal Aortic Aneurysms
|
N/A |