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Clinical Trial Summary

Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05442489
Study type Expanded Access
Source W.L.Gore & Associates
Contact Sarah Rosbach
Phone 800-437-8181
Email AAA1701@wlgore.com
Status Available
Phase

See also
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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