Relay Branch (Thoracic Aortic Disease) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the study device, the RelayBranch System, and to find out if it is safe and effective in the treatment of thoracic aortic disease.

What is the Condition Being Studied?

Thoracic Aortic Disease

Who Can Participate in the Study?

Adults with at least one of the following:
-Thoracic aortic aneurysm (a weakening of bulging of the aorta)
-Thoracic penetrating atherosclerotic ulcer (a thickening of the aortic wall)
-Thoracic aortic dissection (a tear in the aortic wall)
-Thoracic intramural hematoma (collection of blood due to a tear in the aortic wall)

Age Group

What is Involved?

If you agree to be in this study, you will:
- Have your aorta repaired using the RelayBranch system (study device)
- Have up to 8 CT scans
- Have up to 7 chest x-rays
- Have an MRI
- Have study visits and phone calls for 5 years after your aortic repair surgery

Study Details

Full Title
A Prospective, Multicenter, Non-Blinded, Non-Randomized Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System in Subjects with Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery
Principal Investigator
Protocol Number
IRB: PRO00103090
NCT: NCT03214601
Phase N/A
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center