Feasibility of Endovascular Repair Of Ascending Aortic Pathologies

Launched by RODNEY A. WHITE, MD · Jul 24, 2014

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for patients with serious conditions affecting the ascending aorta, which is the large artery that carries blood away from the heart. Specifically, the study focuses on patients with type A aortic dissection, intramural hematoma, penetrating ulcers, or pseudoaneurysms. These conditions can be life-threatening if not treated. The trial aims to see how well the Medtronic Valiant PS-IDE Stent Graft works to repair these issues within the blood vessel. This stent is designed to help reroute blood flow and strengthen the aorta, potentially preventing further complications.

To be eligible for the trial, patients need to be between the ages of 65 and 74 and have one of the specified conditions affecting a certain part of the ascending aorta, without involvement of the aortic valve. They must also be considered high-risk surgical candidates. Participants will receive the stent graft and be closely monitored to assess how effectively it treats their condition. This study is important because it could offer a new, less invasive way to manage serious aortic problems, which are usually treated with more extensive surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient must have a Type A thoracic aortic dissection, retrograde Type A thoracic aortic dissection, intramural hematoma, penetrating ulcer or pseudoaneurysm of the ascending thoracic aorta affecting the area between the Sinus of Valsalva and the innominate artery orifice (with no involvement of the aortic valve) and be considered candidates for endovascular repair;
• • Patient must also have at least one cm proximal and distal landing zones in the ascending aorta between 28-44 mm in diameter;
• • The patient must be deemed high-risk surgical candidate according to the following established criteria: ASA (American Society of Anesthesiologists) class IV.
• Exclusion Criteria:
• • Pregnant or pediatric patients (younger than 21 years of age);
• • Patients who have a condition that threatens to infect the stent graft/aortic valve prosthesis;
• • Patients with allergies to the stent graft material;
• • Patients or their legally authorized representatives who do not sign the informed consent;
• • Patients with expected survival less than one year.