Recruiting

Endovascular Repair

Sponsor:

Rodney A. White, MD

Code:

NCT02201589

Conditions

Aortic Dissection

Intramural Hematoma

Penetrating Ulcer

Pseudoaneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endovascular repair with Valiant PS-IDE Stent Graft

Study Details

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.

Conditions

Aortic Dissection

Intramural Hematoma

Penetrating Ulcer

Pseudoaneurysm

Study ID

NCT02201589

Start date

Nov, 2013

Status verified date

May, 2025

Completion date

Dec, 2033

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Endovascular repair of ascending aorta

Endovascular repair with Valiant PS-IDE Stent Graft

Interventions

Endovascular 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

Primary outcome measure

  • Composite of all cause mortality, re-interventions, surgical conversions, post-procedural strokes and ischemic or hemorrhagic events causing motoric, language or cognitive compromise [ Time Frame: Within 30 days of the index procedure ]

Central Contacts and Locations

Central contacts

Rodney A White, M.D.

310 222-2704rawhite@ucla.edu

Ali Khoynezhad, M. D., PhD

310 423-3851ali.khoynezhad@cshs.org

Locations

Long Beach Memorial Medical Center

Recruiting

Long Beach, California, United States, 90806

Contacts

Rodney A White, MD

310.963.5230rawhite@ucla.edu

Ali Khoynezhad, MD

310-498-2091akhoynezhad@memorialcare.org

Principal Investigator:

Rodney A. White, MD

LAC Harbor-UCLA Medical Center

Recruiting

Torrance, California, United States, 90502

Principal Investigator:

Rodney A White, MD

More Information

Sponsor

Rodney A. White, MD

Last update posted

May 6, 2025

Last verified

May, 2025

Keywords

  • Lesions in the ascending thoracic aorta

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rodney A. White, MD on 2025-05-06.