Endovascular stent repair for retrograde ascending aortic dissection

A Single-arm, Open-label, Multicenter Clinical Study Evaluating the Safety and Efficacy of Endovascular Treatment for Retrograde Dissections Involving the Ascending Aorta That Are Not Suitable for Open Surgery. （RADIAL)

This trial will try an endovascular stent procedure to repair retrograde ascending aortic dissection in people aged 65 or older who are not suitable for open surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 149 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07405242 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people aged 65 or older with imaging-confirmed retrograde dissection originating in the arch or descending aorta, with the most distal tear at least 2 cm from the coronary ostia, who have been deemed unsuitable for open surgery and have suitable arterial access.

Not a fit: Patients whose tears are too close to the coronary ostia, who have severe organ ischemia or organ failure, or who lack safe arterial access are unlikely to benefit from this endovascular approach.

Why it matters

Potential benefit: If successful, this could provide a less-invasive option to seal the dissection and reduce life-threatening complications for patients who cannot undergo open surgery.

How similar studies have performed: Endovascular repair of ascending aortic dissection is relatively novel: small case series and registry reports show promising results but it is not yet validated in large randomized trials.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Junyi Yan, M.D.

Conditions: Ascending Aortic Dissection