Stanford type A aortic dissection
Conditions
Interventions
Experimental group:Type A aortic lesions total cavity reconstruction system
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 70 years and have been assessed as having a high risk of surgery by two or more cardiac team physicians; 2. Aged >=18 years and =60mm; Aortic diameter 24mm-42mm); 5. The location of the first break (aortic valve) is more than 10mm from the coronary artery or/and the location of the break is more than 5mm from the opening of the three branches of the arch; 6. Endoaortic therapy can be performed with appropriate vascular approach; 7. Be able to understand the purpose of the study, voluntarily participate in the study, the subjects themselves or their guardians sign the informed consent, and are willing to complete the follow-up according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients who cannot use contraception during pregnancy or lactation or during the trial; 2. Participating in other drug or device clinical trials and not meeting the primary endpoint; 3. Patients with previous aortic surgery at the same surgical site; 4. Patients who are known to be allergic to contrast agents, anesthetic drugs, stents and delivery materials; 5. Patients with contraindications to antiplatelet drugs and anticoagulants; 6. Patients with severe abnormal liver function before surgery (the upper limit of alanine aminotransferase or aspartate aminotransferase is more than 2.5 times of the normal upper limit); 7. Patients with severe renal dysfunction (serum creatinine more than 2 times the upper limit of normal) before surgery; 8. Patients with severe coagulation insufficiency or bleeding tendency (platelet count less than 40*10^9/L); 9. Diseases of the blood system, anemia, hemoglobin less than 90g/L; 10. Patients who are paraplegic or in a coma; 11. History of myocardial infarction, transient ischemic attack (TIA), cerebral infarction or cerebral hemorrhage within the last 3 months; 12. Dissection involves aortic valve and coronary artery opening; 13. The interlayer break is located in the aortic arch; 14. Life expectancy less than 12 months (e.g. advanced malignancy); 15. Acute systemic infection; 16. Patients with severe cardiopulmonary insufficiency (LVEF < 35%) or (blood oxygen saturation < 90%) or poor physical conditions that cannot tolerate interventional surgery; 17. Patients with a history of major surgical operations within the last 3 months; 18. Patients with a history of massive gastrointestinal bleeding in the last 3 months; 19. Additional conditions determined by the investigator to be unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of operation ; | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause mortality;Incidence of serious adverse events and device-related adverse events;Success rate of device implantation;Incidence of type I/III internal leakage; | — |
Countries
China
Contacts
Public ContactFan Ruixin
Guangdong Provincial People's Hospital
Outcome results
None listed