Endovascular repair for ascending aortic conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the outcomes of patients with various pathologies of the ascending thoracic aorta, including type A aortic dissection and pseudoaneurysms, who are suitable for endovascular repair using the Medtronic Valiant PS-IDE Stent Graft. A total of 20 patients will be enrolled and followed for five years post-surgery. Participants will undergo a series of imaging tests, including CT scans and echocardiograms, to monitor their condition and the effectiveness of the stent graft over time.

Why it matters

Who can join: the full rules

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.

Where it's running

• Long Beach Memorial Medical Center
  Long Beach, California, United States Recruiting
• LAC Harbor-UCLA Medical Center
  Torrance, California, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Terminated

Study contacts

• Principal investigator: Rodney A White, M.D. — LA BioMedical Research Institute at Harbor-UCLA Medical Center
• Study coordinator: Rodney A White, M.D.
• Email: rawhite@ucla.edu
• Phone: 310 222-2704

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ketorolac to improve outcomes and prognosis in Stanford Type A aortic dissection

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• WeFlow-EndoPatch for Distal Aortic Tear Repair in Chronic Dissection

  This study tests whether the WeFlow-EndoPatch Aortic Endovascular Patch can safely and effectively seal distal tears in chronic aortic dissection compared with standard treatment.

  Recruiting Hangzhou Endonom Medtech Co., Ltd. · Beijing, Beijing Municipality · NCT06945809

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.