NCT02201589 Feasibility of Endovascular Repair Of Ascending Aortic Pathologies
| NCT ID | NCT02201589 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rodney A. White, MD |
| Condition | Aortic Dissection |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2013-11 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2013-11 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Rodney A White, M.D.
PRINCIPAL INVESTIGATOR
LA BioMedical Research Institute at Harbor-UCLA Medical Center
Frequently Asked Questions
Who can join the NCT02201589 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Dissection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02201589 currently recruiting?
Yes, NCT02201589 is actively recruiting participants. Contact the research team at rawhite@ucla.edu for enrollment information.
Where is the NCT02201589 trial being conducted?
This trial is being conducted at Long Beach, United States, Los Angeles, United States, Torrance, United States.
Who is sponsoring the NCT02201589 clinical trial?
NCT02201589 is sponsored by Rodney A. White, MD. The principal investigator is Rodney A White, M.D. at LA BioMedical Research Institute at Harbor-UCLA Medical Center. The trial plans to enroll 20 participants.