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Feasibility of Endovascular Repair for Ascending Aortic Pathologies

This study is looking at the Medtronic Valiant PS-IDE Stent Graft (a device used to repair blood vessels) for people with certain conditions affecting the ascending aorta (the large blood vessel leaving your heart). These conditions include aortic dissection (a tear in the aortic wall), intramural hematoma, penetrating ulcer, or pseudoaneurysm. The study aims to see how well this endovascular repair (repair from inside the blood vessel) works. Researchers will measure outcomes like death, needing more procedures, strokes, or other serious events within 30 days of the procedure. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 20 participants. It is a prospective study, meaning participants will be followed forward in time.
What's involved
You would have a CT scan and echocardiogram 30 days after the device is implanted. You would then have CT scans at 6 and 12 months, and yearly from 2 to 5 years after the implant.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years after the stent graft is implanted.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02201589

Feasibility of Endovascular Repair Of Ascending Aortic Pathologies

Recruiting
NAAges 18+InterventionalTreatment
Rodney A. White, MD
~20 participants
Updated 2025-05-06 on ClinicalTrials.gov
What's tested:Endovascular repair with Valiant PS-IDE Stent Graft

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite of all cause mortality, re-interventions, surgical conversions, post-procedural strokes and ischemic or hemorrhagic events causing motoric, language or cognitive compromise
Measured over Within 30 days of the index procedure

Conditions

Aortic Dissection
Intramural Hematoma
Penetrating Ulcer
Pseudoaneurysm

Explore related trials

Aortic DissectionIntramural hematomaPenetrating ulcerPseudoaneurysm

Where it's being run

3 sites across 1 states
California3

Study leadership

  • Rodney A White, M.D. · PRINCIPAL_INVESTIGATOR · LA BioMedical Research Institute at Harbor-UCLA Medical Center
  • Ali Khoynezhad, M.D. PhD. · PRINCIPAL_INVESTIGATOR · LA BioMedical Research Institute at Harbor-UCLA Medical Center

Who to contact

Rodney A White, M.D.
[email protected]
310 222-2704
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Composite of all cause mortality, re-interventions, surgical conversions, post-procedural strokes and ischemic or hemorrhagic events causing motoric, language or cognitive compromiseWithin 30 days of the index procedure

    Mortality, re-interventions, surgical conversions and post-procedure adverse events