Study of Endovascular Repair Using Medtronic Valiant PS-IDE Stent Graft for Ascending Aortic Diseases

What this Trial Is About

This research aims to evaluate outcomes for patients with diseases of the ascending thoracic aorta, including type A aortic dissection, retrograde type A aortic dissection, intramural hematoma, penetrating ulcer, and pseudoaneurysm. These conditions involve damage or tears in the aortic wall that can lead to enlargement or rupture, potentially causing serious harm or death. The study focuses on patients suitable for endovascular repair using the Medtronic Valiant PS-IDE Stent Graft, which has been used extensively in similar conditions in other parts of the aorta. The trial involves repairing the ascending thoracic aorta by implanting the Medtronic Valiant PS-IDE Stent Graft with the Captivia Delivery System. This device is a stent frame made from Nitinol wire covered with polyester material and is intended to reroute blood flow by covering the tear in the aorta. The study plans to enroll 20 patients who will receive this endovascular repair procedure and be followed over time. Participants will be monitored for 5 years after the procedure, with scheduled assessments including CT scans with and without contrast and echocardiograms. These evaluations take place 30 days after implantation, then at 6 and 12 months, and annually from years 2 through 5. Researchers will measure outcomes such as mortality, strokes, surgical conversions, and other complications within 30 days post-procedure, as well as device delivery success and aortic remodeling based on imaging over time.

Feasibility of Endovascular Repair Of Ascending Aortic Pathologies