Endovascular repair for ascending aortic pathologies

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 early feasibility study aims to evaluate the outcomes of patients with ascending thoracic aortic pathologies, specifically type A aortic dissection, who are eligible for endovascular repair using the Medtronic Valiant PS-IDE Stent Graft System. The study will focus on patients with dissections affecting the aorta between the Sinus of Valsalva and the innominate artery orifice, ensuring no involvement of the aortic valve. The intervention involves repairing the ascending aorta by covering the proximal tear and rerouting blood to the true lumen. A total of 20 high-risk surgical patients will be enrolled in this study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* In order to qualify for this physician-sponsored Investigational Device Exemption, the patients would have to meet the entire entry criteria listed below, sign a consent approved by the FDA and IRB, and agrees to follow-up according to the study protocol.

  * Patient must have a type A thoracic aortic dissection, retrograde type A thoracic aortic dissection 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 a candidate for endovascular repair;

    * The proximal and distal landing zones for placement of graft should be at least 1 cm.
    * The proximal landing zone will allow placement of the stent graft as to not inhibit valvular function, occlude a coronary ostium or proximal bypass graft; The aortic root may be dissected, but the proximal tear site must be at least 1cm from the STJ (and within the above listed size criteria).
    * Distal landing zone must allow for continued perfusion of critical cerebral vessels;
    * The aorta as measured adventitial wall to adventitial wall must be greater than 28 mm and no more than 44 mm maximum diameter at both the proximal and distal landing zone.
    * The patient must be high-risk surgical candidate according to the following established criteria: ASA score of 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 representative (LAR) who do not sign the informed consent;
* Patients with expected survival less than one year due to a condition other than the ascending aortic

Where it's running

• Baylor Scott & White The Heart Hospital
  Plano, Texas, United States Recruiting

Study contacts

• Principal investigator: William Brinkman, MD — Cardiac Surgery Specialists
• Study coordinator: Megan C White, BA
• Email: megan.white1@bswhealth.org
• Phone: 469-814-4720

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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.