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This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

Gore TAMBE PAS - Clinical Trial

What is the Purpose of this Study?

We are dong this study to collect information about the use of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device). The TAMBE Device was approved by the FDA in 2024 for use in endovascular repair as a treatment for patients with thoracoabdominal and pararenal aortic aneurysms. We want to get data about how well the device performs in the patients who choose to get this implant.

What is the Condition Being Studied?

Thoracic Aortic Disease

Who Can Participate in the Study?

Adults ages 18+ who:

  • Have aortic disease in need of endovascular repair
  • Plan to get the Gore TAMBE device for treatment

For more information, please contact the study team at hillary.hood@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, we will schedule you for follow-up visits following your procedure to implant the Gore TAMBE device. These visits will include physical exams, blood draws, CT scans, and neurological testing. The visits will happen according to the following schedule:

  • 1 month after your procedure
  • 6 months after your procedure
  • Once per year for 10 years after the second visit

Study Details

Full Title
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Post-Approval Study
Principal Investigator
Heart Surgeon
Protocol Number
IRB: PRO00116971
NCT: NCT06578741
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon