Stanford type A aortic dissection
Conditions
Interventions
???:Xuper Open Surgery Stent Graft System for the surgery
???:Intergard artificial blood vessel for the surgical of type A aortic dissection therapy
Sponsors
Changhai Hospital of Second Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Patient aged 18 to 65 years old; 2) The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial; 3) The patient is diagnosed with Stanford type A aortic dissection; 4) The anatomical morphology of aortic arch meets the basic requirement of implantation device; 5) Patient without surgical contraindications which include severe function insufficiency of liver, kidney, heart or lung, or a history of cerebral coma.
Exclusion criteria
Exclusion criteria: 1) Female patients in pregnancy or lactation; 2) Patients with thrombocytopenia or are undergoing anticoagulant therapy; 3) Patients who are currently receiving dialysis treatment or the renal function are impaired(Serum Creatinine>200umol/L); 4) The patient has had surgical repair of thoracoabdominal aortic aneurysm; 5) The branches of aortic arch vascular variation; Aberrant right/left subclavian artery, innominate artery and left common carotid artery from a common stem; Vertebral artery directly originated from the aortic arch and so on; 6) The Patient had sufferred myocardial infarction within 3 months before screening; 7) Pulmonary dysfunction: Forced expiratory volume at 1st second50mmHg; 8) The patient with severe heart disease at present (Such as congestive heart-failure,untreated or deterioration of cardiac arrhythmias,ventricular arrhythmias); 9) Patients with known allergy to contrast agent and the anesthetic; 10) Patients with active systemic infection; 11) Patients has been involved in other drugs or medical devices clinical trials; 12) No matter before or after the treatment, Patient who the investigator judged may have problems of medical, social or psychological that unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The duration of circulatory arres; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of major adverse events(death, paraplegia, Brain complications);Stent implantation successful (stent in place and successfully release);Operation time, cardiopulmonary bypass time, Arterial anastomosis time, aortic occlusion time, intraoperative blood loss and blood transfusion volume;Treatment success (12 months after operation); | — |
Countries
China
Contacts
Public ContactZhiyun Xu
Changhai Hospital of Second Military Medical University
Outcome results
None listed