Endovascular stent repair for retrograde ascending aortic dissection

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 is a single-arm, open-label, multi-center study testing endovascular stent implantation to treat retrograde dissection that extends into the ascending aorta. Eligible patients have a tear in the aortic arch or descending aorta that extends retrogradely at least 2 cm from the coronary ostia and have been judged unsuitable for open surgical repair. The study will monitor short-term safety at 30 days and medium- to long-term outcomes at 6 and 12 months after the procedure. Procedures require adequate arterial access for delivery of the stent system and follow standardized imaging-confirmed endpoints.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntary participation in the clinical trial; The individual fully understands and is informed of this study and has signed the informed consent form; Willing to follow and be able to complete all trial procedures
* Age ≥ 65 years old, both male and female are eligible
* Confirmed by imaging to be retrograde tear aortic dissection, that is, the tear site is located at the aortic arch or descending aorta, and the retrograde tear involves the ascending aorta. The farthest segment of the dissection tear is ≥ 2 cm from the coronary artery outlet
* Evaluation by cardiac surgery indicates that open surgical treatment is not suitable, performing open surgery poses significant risks or the risks outweigh the benefits
* Arterial access conditions are permitted, without severe stenosis or distortion, and the stent delivery system can be smoothly introduced;

Exclusion Criteria:

* Severe organ ischemia or functional failure, which, after assessment, is considered to have an extremely poor prognosis and cannot benefit from endovascular treatment, such as extensive cerebral infarction or cerebral hemorrhage, resulting in irreversible severe neurological deficits, acute extensive ischemic necrosis of the mesenteric arteries, acute liver and kidney failure;
* Planned to undergo aortic valve repair/replacement or coronary artery interventional therapy within 30 days;
* Mechanical heart valve present at the aortic valve position;
* Aortic valve regurgitation degree ≥ 3+ or 4+;
* Known severe allergy to contrast agents or stent materials (such as nickel-titanium alloys, polyester, etc.);
* Severe systemic infection that may lead to infection after stent implantation;
* Severe coagulation dysfunction, which, after correction, still cannot meet the surgical requirements, or has bleeding tendencies;
* Complicated with other serious diseases or malignant tumors, with a predicted survival period of less than 12 months;
* Pregnant or lactating women;
* With mental illness or cognitive impairment, unable to understand and cooperate with the study;
* Already participating in other ongoing interventional clinical studies;
* Other situations judged by the investigator as not suitable for inclusion in the study;

Where it's running

• Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Junyi Yan, M.D.
• Email: yanjy0117@gmail.com
• Phone: +8613480161737

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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.