TAMBE Pivotal Study (AAA 17-01) (Version 1.0)
Research type
Research Study
Full title
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
IRAS ID
260311
Contact name
Amanda Bridges
Contact email
Sponsor organisation
WL Gore and Associates Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 6 months, 0 days
Research summary
The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) device in the treatment of thoracoabdominal and pararenal aortic aneurysms
The study will be separated into two arms based on anatomic eligibility and the extent of the aneurysm. Patients with aneurysms covering most or all of the abdominal aorta, including the renal arteries and extending as far as 65mm proximal to the celiac artery (classified as Crawford Type IV aneurysms) will be enrolled in the primary study arm and will receive the TAMBE device. Patients with more extensive thoracoabdominal aneurysmal coverage (Crawford Types I-III) will be enrolled in the secondary study arm and will receive the TAMBE device and a proximal extension using the Conformable GORE® TAG® Thoracic Stent Graft(CTAG) Device.
The study will be conducted in up to 45 hospitals in the US and EU and in up to 202 patients in total (102 in the primary arm and 20-100 in the secondary arm). The study will be conducted in one hospital in the UK with approximately 10 patients recruited.
Adult patients will be enrolled into the study provided that all protocol inclusion/exclusion criteria are met. Participants will be evaluated through hospital discharge and at approximately 1 month, 3 months, 6 months and annually through 5 years after their procedure.
REC name
London - Stanmore Research Ethics Committee
REC reference
19/LO/0987
Date of REC Opinion
23 Aug 2019
REC opinion
Further Information Favourable Opinion