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A clinical trial protocol to evaluate the efficacy and safety of endovascular stents for complete endovascular repair of aortic dissection

A clinical trial protocol to evaluate the efficacy and safety of endovascular stents for complete endovascular repair of aortic dissection

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055277
Enrollment
Unknown
Registered
2022-01-05
Start date
2022-01-06
Completion date
Unknown
Last updated
2023-01-23

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

Conditions

Aortic Dissection

Interventions

Experimental group:Implanted endovascular stent

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 80 years; 2. Patients with a definite diagnosis of type B aortic dissection and continuous involvement of at least one iliac artery requiring treatment; 3. The average life expectancy is greater than 24 months; 4. ASA <= 3 (American Society of Anesthesiologists (ASA) is less than or equal to 3); 5. The vessel wall at the proximal attachment area of the stent is normal; 6. The patient can understand the purpose of the trial, participate voluntarily and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients without suitable vascular access; 2. The patient has a clear history of allergy to nickel-titanium alloy materials; 3. Patients with liver and kidney insufficiency (creatinine is greater than 2.5 times the upper limit of normal; ALT and AST are greater than 2.5 times the upper limit of normal (ULN)); 4. Patients who cannot be followed up on time; 5. The aortic lesion has been ruptured; 6. Myocardial infarction or cerebrovascular accident occurred within 30 days before implantation; 7. Patients who have or are suspected of having connective tissue degenerative diseases, or have related family history; 8. Medical contraindications to local or general anesthesia; 9. Patients with known contraindications to anticoagulants, antiplatelet agents or contrast agents; those who have been or may be allergic to aspirin, clopidogrel, heparin, contrast agents, polylactic acid polymers and rapamycin; 10. Patients undergoing chemotherapy or planning to receive chemotherapy; 11. History of bleeding disorders or coagulation disorders; 12. Aortic fluffy syndrome; 13. Takayasu arteritis; 14. Existing or suspected infection; 15. Severe heart failure (NYHA class III and above); 16. Patients who are pregnant or breastfeeding; 17. Patients within the first 4 weeks or participating in other clinical trials; 18. The investigator judges that the patient has poor compliance and cannot complete the study as required, or the investigator believes that the patient is not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Complete thrombosis rate of false cavity 12 months after endovascular repair;

Countries

China

Contacts

Public ContactZhang Xiaoming

Peking University People's Hospital

chain00@vip.sina.com+86 10 88326666

Outcome results

None listed

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