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

What is the Purpose of this Study?

We are doing this study to learn more about the GORE TAG Thoracic Branch Endoprosthesis (TBE Device), and to find out if it is safe and effective in treating aortic diseases and injuries.

What is the Condition Being Studied?

Diseases of the Aorta

Who Can Participate in the Study?

Adults with aortic disease or injury

Age Group
Adults

What is Involved?

If you agree to be in this study you will:
-Have your aorta repaired using the Gore TAG TBE Device (study device)
-Have 7 CT scans of your chest and abdomen
-Have blood pressure taken on your arms and legs 8 times
-Have neurological assessments
-Have study visits for 5 years after your aortic repair surgery

Some people enrolled in this study will also have the following depending on the location of the aortic repair.
-1 CT scan of your head and neck

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
Protocol Number
IRB: PRO00073810
NCT: NCT02777528
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698