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A clinical trial to evaluate the safety and effectiveness of endovascular stent-grafts with full-coverage architecture and hemodynamic remodeling for the treatment of Stanford A type of aortic dissection

A clinical trial to evaluate the safety and effectiveness of endovascular stent-grafts with full-coverage architecture and hemodynamic remodeling for the treatment of Stanford A type of aortic dissection

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106327
Enrollment
Unknown
Registered
2025-07-22
Start date
2024-11-27
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic dissection type A

Interventions

Experimental group:Aortic dissection type A

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patient is between 18~90 years old; 2. Patients judged by the clinical investigator to be at high risk of surgical procedures (EuroScore score >=6 points); or patients who are judged by the investigator to be unsuitable for surgical procedures; and at any time at risk of death due to poor perfusion of organs or rupture of the aorta; 3. For various reasons, the first surgical operation only performs aortic root replacement or ascending aortic replacement, but the remaining aortic arch and distal dissection are poorly perfused due to occlusion of the true lumen (almost) or involvement of branch vessels, and should be further treated at the same time or after surgery; 4. Patients are able to understand the purpose of the trial, voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with no suitable vascular approach; 2.The patient has a clear history of allergy to Nitinol materials; 3.The patient cannot attend the interview on time; 4.The aortic lesion has ruptured causing shock and coma; 5.Patients who had myocardial infarction or cerebrovascular accident within 30 days before implantation and did not recover; 6.Patients who have or are suspected to have connective tissue degenerative disease, or have a family history of it; 7.Medical contraindications to local or general anesthesia; 8.Patients who are known to contraindicate anticoagulants, antiplatelet agents, or contrast agents; 9.People who have or may be allergic to aspirin, clopidogrel, heparin and contrast agents; 10.Patients who are receiving or planning to receive chemotherapy; Life expectancy is not more than one year; 11.History of bleeding disorders or clotting disorders; 12.Aortic fluffiness syndrome; 13.Multiple aortitis; 14.Pregnant or lactating women; 15.The investigators judged that the patients had poor compliance and could not complete the study as required; Or patients deemed unsuitable for participation in this trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Incidence of new major complications related to aortic dissection at 30 days after surgery;

Secondary

MeasureTime frame
Technical success rate immediately after surgery;Treatment success rate;No aortic rupture 30 days after surgery;Pre-discharge aortic lumen remodeling results;Pre-discharge branch patency rate;Stent graft transfer before discharge (>=1cm);Transfer to the surgical group before discharge;

Countries

China

Contacts

Public ContactLiu Yongmin

Beijing Anzhen Hospital Affiliated to Capital Medical University

15901281629@205.com+86 10 64412423

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026