IRB Study Number 18-061
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
(RELAY BRANCH) A Prospective, Multicenter, Non-Blinded, Non-Randomized Early Feasibility Study of the Relay Branch Thoracic Stent-Graft System in Subjects with Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery
Inclusion Criteria
Age ≥18 years
Aneurysm (=/>5.5) of the ascending aorta, aortic arch, or proximal descending aorta
Chronic, uncomplicated type B aortic dissection or IMH with time from symptom onset to diagnosis ≥ 60 days
(Not inclusive)
Exclusion Criteria
Prior endovascular repair in the ascending/descending thoracic aorta or aortic arch.
Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed less than 6 months prior to the planned stent implant procedure
Prior aortic valve replacement (mechanical valve)
Significant stenosis, calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device
(Not inclusive)
