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Feasibility of Endovascular Repair Of Ascending Aortic Pathologies

RecruitingNAAges 18 Years - anyAllRodney A. White, MD
NCT02201589 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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;

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📋 Eligibility rules (as published)
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.
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What it tests

  • Endovascular repair with Valiant PS-IDE Stent Graft
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Where

3 sites
Long Beach Memorial Medical Center
Long Beach, United States
Cedars Sinai Medical Center
Los Angeles, United States
LAC Harbor-UCLA Medical Center
Torrance, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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