Type A Aortic Dissection
Conditions
Interventions
experimental group:Surgery of Stanford type A aortic dissection using multi-branched stent graft prosthesis (sutureless integrated stented graft prosthesis)
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 18 and 80 years old; (2) Identified Stanford type A aortic dissection patients; (3) Patients who are able to understand the purpose of the study and participate voluntarily and sign informed consent in conjunction with clinical follow-up.
Exclusion criteria
Exclusion criteria: (1) Patients with severe malperfusion syndrome, e.g. coma, paraplegia, progressive liver dysfunction, Gastrointestinal necrosis, extremity necrosis, etc.; (2) Patients undergoing continuous renal replacement therapy or presenting with renal dysfunction (serum cretenine > 200µmol/L); (3) Patients with severe liver dysfunction (total bilirubin > 205µmol/L); (4) Patients with severe myocradial injury (Troponin I being 100 times larger than upper limit of normal value); (5) Patients with myocardial infarction within 3 months; (6) Patients with severe infections that cannot be controlled and induce sepsis, shock or multi-organ failure; (7) Patients who are intolerant to anaesthesia or cardiopulmonary bypass; (8) Patients who underwent surgery within 3 months; (9) Patients who underwent thoracic aortic surgery or abdominal aortic surgery previously; (10) Patients with active bleeding previously or refusing to receive blood products transfusion; (11) Pregnant or lactating patients; (12) Patients allergic to contrast agent; (13) Patients with a life expectancy of less than 1 years; (14) Patients who participated in any on-going clinical trial of drug of medical device before being recruited; (15) Patients who are not suitable for this study after evaluation by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative 1-year rate of being free from Major Adverse Event (MAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of successful medical device implantation;Postoperative all-cause mortality;Postoperative rate of complete flase luman thrombosis in the stented segment of thoracic aorta;Postoperative rate of stroke;Postoperative rate of spinal cord injury;Postoperative rate of unexpected aortic reoperation;Postoperative rate of pseudoaneurysm in anastomosis segment;Circulatory arrest time;Cardiopulmonary bypass time; | — |
Countries
China
Contacts
Public ContactCuntao Yu
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed