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Gore TAG TBE Study for Narrowing of the Aorta - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the Gore Thoracic Branch Endoprosthesis device is safe and effective for the treatment of aortic lesions of the aortic arch and the descending thoracic aorta.

What is the Condition Being Studied?

Diseases of the Aorta (bulges, tears, blood clots, wounds or trauma in the aortic arch and descending thoracic aorta)

Who Can Participate in the Study?

Adults with Thoracic Aortic Lesions

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Have the GORE Tag Endoprosthesis device (also known as a stent) placed in your aorta through an incision into an artery in your groin
- Have study visits at before and after your procedure and at discharge, 30 days, 6 months and yearly up to 5 years.
- Have tests done including ankle and brachial pressures, blood tests, questionnaires and CT scans done with your normal routine visits at 1, 6, 12, 24, 36, 48 and 60 months after your procedure

Study Details

Full Title
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta
Principal Investigator
Heart Surgeon
Protocol Number
IRB:PRO00073810
NCT:NCT02777528
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698