Gore TAMBE PAS - Clinical Trial

What is the Purpose of this Study?

In this study, people will have a device called the Gore TAMBE placed in their body. After the device is placed, doctors will check on them at about one month, six months, and then once each year for ten years. At these visits, people will have a physical exam, blood tests, CT scans, and tests to check how their brain and nerves are working.

What is the Condition Being Studied?

Thoracic Aortic Disease

Who Can Participate in the Study?

Adults with aortic disease in need of endovascular repair

Age Group
Adults

What is Involved?

This study is being done to collect information about a medical device called the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis, also known as the TAMBE Device. This device is already approved for use by the FDA. It is used to help doctors fix large weak areas in the main blood vessel, called aneurysms, near or involving the kidneys and other major organs. The study will help doctors learn more about how the device works in patients.

Study Details

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