RecruitingNot ApplicableNCT02201589

Feasibility of Endovascular Repair Of Ascending Aortic Pathologies

Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair Of Ascending Aortic Pathologies


Sponsor

Rodney A. White, MD

Enrollment

20 participants

Start Date

Nov 1, 2013

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to investigate the outcome of patients with pathologies of the ascending thoracic aorta (diseases in the great blood vessel or artery that leads away from the heart) including type A aortic dissection, retrograde type A aortic dissection, intramural hematoma, penetrating ulcer or pseudoaneurysm who are suitable for endovascular (within the vessel) repair with the Medtronic Valiant PS-IDE (Physician Sponsored-Investigational Device Exemption) Stent Graft. Type A aortic dissection is a condition where blood passes through the inner lining or between the layers of the blood vessel from a tear in the aortic wall (dissection) in the ascending aorta; a retrograde Type A aortic dissection is a condition where the dissection or tear in the ascending aorta starts from the descending aorta; an intramural hematoma is a collection of clotted blood within the aortic wall; a penetrating ulcer has a plaque or clot within the wall and a pseudoaneurysm is a false aneurysm . If left untreated in any of these conditions, the aorta can enlarge and rupture causing injury or death. The plan for these patients is to repair the ascending thoracic aorta using the Medtronic Valiant PS-IDE Stent Graft with the Captivia Delivery System. The Valiant Captivia has been evaluated worldwide and used extensively in patients with type B (descending) thoracic aortic dissection. Since the dissections in the ascending aortas mirror that of the descending aorta, it is expected that this stent graft will deliver similar performance and endurance in patients with type A aortic dissection. The investigators expect to reroute the blood to the true lumen (the inner space within the blood vessel) by covering the proximal (nearest to the heart) tear with the stent graft. The stent graft is a stent frame made from Nitinol wire and covered with an expandable material made of a polyester material. This new study will determine how well the device works to treat dissections, intramural hematomas, penetrating ulcers and pseudoaneurysms in the ascending thoracic aorta.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether endovascular repair (a minimally invasive catheter-based approach, rather than open surgery) is a feasible treatment for complex problems affecting the ascending aorta — the major artery exiting the heart. It focuses on patients who are considered too high-risk for traditional open-heart surgery. You may be eligible if: - You have a Type A aortic dissection, intramural hematoma, penetrating ulcer, or pseudoaneurysm in the ascending thoracic aorta - The affected area does not involve the aortic valve - You have at least 1 cm of healthy aorta above and below the problem area (suitable landing zones) - You are considered a high surgical risk (ASA Class IV) - You are 18 years of age or older You may NOT be eligible if: - You are pregnant or under 21 years old - You have an infection that could infect the stent graft or aortic valve - You are allergic to the stent graft material - You or your legal representative cannot or will not sign informed consent - Your expected survival is less than one year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEEndovascular repair with Valiant PS-IDE Stent Graft

Endovascular stent graft repair of lesions in the ascending thoracic aorta using the Medtronic Valiant PS-IDE (Physician Sponsored-Investigational Device Exemption) Stent Graft System with the Captivia Delivery System


Locations(3)

Long Beach Memorial Medical Center

Long Beach, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

LAC Harbor-UCLA Medical Center

Torrance, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT02201589


Related Trials