Type A aortic dissection
Conditions
Interventions
experimental group:Vascular stent system
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) 18 years old =80 years old, gender is not limited; 2) Diagnosed with Stanford type A aortic dissection; 3) Be able to understand the purpose of the experiment, voluntarily participate and sign the informed consent, and be willing to conduct interviews.
Exclusion criteria
Exclusion criteria: 1) Preoperative aortic dissection with severe malperfusion syndrome, such as coma due to ischemia or Paraplegia, progressive liver function damage, gastrointestinal necrosis, limb necrosis, etc. 2) Patients are on dialysis or have renal function impairment (creatinine greater than 200µmol/L); 3) Severe hepatic insufficiency (TBIL greater than 205µmol/L); 4) Patients with a history of myocardial infarction 3 months before surgery; 5) Uncontrolled severe infection and related sepsis, shock or multiple organ failure; 6) Can not tolerate anesthesia and cardiopulmonary bypass; 7) Patients who have undergone major surgical operations within 3 months; 8) Have a history of active bleeding or refuse blood transfusion; 9) Patients with clear coagulation dysfunction and severe coagulation system diseases; 10) Patients with clear contraindications in the use of anticoagulants; 11) Pregnant or lactating women; 12) People who are known to be allergic to contrast agents, polyester, Nitinol or bovine products; 13) Life expectancy is less than 12 months; 14) Participants who had participated in other drug or medical device clinical studies before inclusion but had not completed the primary endpoint; 15) The researchers believe that it is not suitable to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of intraoperative instrument implantation;All-cause mortality at 30 days after surgery;Significant adverse events were avoided 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device implantation success rate;All-cause mortality;The incidence of complete thrombus in the area covered by the coated stent;Incidence of stroke;Incidence of paraplegia;Unexpected incidence of aortic related secondary surgery;Incidence of pseudoaneurysm in anastomotic area;Stop cycle time;Cardiopulmonary bypass time; | — |
Countries
China
Contacts
Public ContactLizhong Sun
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed