Stanford A aortic dissection
Conditions
Interventions
Experimental group:Branch-type intraoperative stent system with double branch structure
Control group:Stent Graft System In Surgical Operation
Single Group :A branched-type intraoperative stent system with a single branch structure
Learning Curve:Branch-type intraoperative stent system with double branch structure
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, male or female; 2. Stanford type A aortic dissection subjects with involvement of the descending arch aorta; 3. Subjects treated with stent pictorial procedures as judged appropriate by the investigator; 4. Subjects or their legal surrogates were able to understand the purpose of the study, had adequate compliance to the clinical study protocol, and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with aortic dissections confined to the ascending and / or arch; 2. Subjects with a left common carotid artery branch vessel diameter 16 mm (not applicable to subjects enrolled with a single branch structure); 3. Subjects with a left subclavian artery branch vessel diameter 16 mm; 4. Subjects with aortic dissection with severe malperfusion syndrome preoperatively (e.g., subjects presenting with coma, paraplegia, need for dialysis, gastrointestinal necrosis or limb necrosis due to ischemia, etc.); 5. Subjects with vertebral artery variants; 6. Subjects with infectious aortic dissections; 7. Subjects with acute systemic infection, severe infection and associated sepsis, shock or multiple organ failure; 8. Subjects unable to tolerate anaesthesia and cardiopulmonary bypass; 9. Subjects who had undergone open surgical procedures of the cardiocerebral vasculature within 90 days prior to surgery; 10. Subjects with history of active bleeding, coagulopathy or refusal of blood transfusion; 11. Subjects known to be allergic to materials such as contrast agents, nitinol alloys, coated artificial blood vessels; 12. Subjects with a life expectancy of less than 12 months (other than disease due to aortic dissection); 13. Subjects being enrolled in other clinical trials; 14. Pregnant and lactating women, and subjects with a recent pregnancy preparation; 15. Subjects with poor compliance other conditions that the investigator considers inappropriate for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year all-cause mortality after procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device implantation success rate;Operation sucess rate;30 day all-cause mortality after procedure;Sham cavity thrombosis occurred at 6 and 12 months after the procedure;Branch patency at 12 months after surgery;Secondary intervention rate of target lesions 12 months after surgery; | — |
Countries
China
Contacts
Public ContactWang Chunsheng
Zhongshan Hospital, Fudan University
Outcome results
None listed