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A Randomized Controlled Trial for Evaluation of the Safety and Efficiency of Post-TEVAR/Sun's Aortic Dissection diatal TL Remodelling using Endoluminal Stent

A Randomized Controlled Trial for Evaluation of the Safety and Efficiency of Post-TEVAR/Sun's Aortic Dissection diatal TL Remodelling using Endoluminal Stent

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023638
Enrollment
Unknown
Registered
2019-06-05
Start date
2018-07-01
Completion date
Unknown
Last updated
2019-06-11

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:TEVAR-Stentgraft+Endoluminal Stent
controll Team:stentgraft

Sponsors

1st Affiliated Hospital of PLA Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 and 80 years old; 2. Patients with a distal rupture requiring a diagnosis of aortic dissection within 0 to 90 days and undergoing conventional stent-graft intervention/30 days after Sun's surgery; 3. The expected life expectancy is greater than 12 months; 4. ASA = 3 (American Society of Anesthesiologists (ASA) is less than or equal to 3); 5. At least one branch artery is involved in the aortic lesion; 6. The proximal or distal attachment zone of the stent is healthy, healthy branches and peripheral vascular veins, and the vascular anatomy of the arterial lesion is sufficient to support stent implantation; 7. The patient can understand the purpose of the trial and voluntarily participate in and sign the informed consent form; 8. Patients are willing to follow-up evaluation according to the requirements of the clinical trial protocol; 9. 0-10 weeks after endovascular repair / 30 days to 10 weeks after Sun surgery, there is still active blood flow in the L2+L3 segment.

Exclusion criteria

Exclusion criteria: 1. Patients without proper vascular access; 2. Patients with chronic aortic dissection; 3. The investigator judged that the patient's compliance was poor and could not complete the study as required; 4. The patient has a clear history of allergy to the alloy material; 5. Patients with renal insufficiency, who have or may have severe reactions to contrast agents; 6. Patients cannot follow up on time; 7. The life expectancy of the patient is less than one year; 8. The aortic lesion is about to rupture or has broken, and the main rupture has failed clinical repair; 9. Aortic lesions involve bilateral lower extremity arteries; 10. Aortic root tumor; 11. Pleural effusion; 12. Surgery was performed within 30 days, excluding surgery for instrument implantation or preparation for anchoring the stent within 30 days of planning; 13. A myocardial infarction or cerebrovascular accident occurred within 6 weeks before implantation; 14. Has or suspected of having a hoof tissue degenerative disease; 15. Medical contraindications for local or general anesthesia; 16. Known allergies or banned anticoagulants, antiplatelet agents or contrast agents; 17. Patients undergoing chemotherapy or planning to receive chemotherapy; 18. History of bleeding disorders or coagulopathy; 19. Aortic fluffy syndrome; 20. Multiple arteritis; 21. Exist or suspected infection (such as aortic mycosis); 22. Aortic fistula; 23. Women during pregnancy or lactation; 24. Those who are participating in other clinical trials; 25. The investigator believes that it is not suitable for patients participating in this trial.

Design outcomes

Primary

MeasureTime frame
Total thrombosis rate in pseudolumen;

Countries

China

Contacts

Public ContactProf. Yu Shiqiang

the 1st Affiliated Hospital of the 4th Military Medical University

yushiq@fmmu.edu.cn+86 029 84775507

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026