Stanford TypeA aortic dissection
Conditions
Interventions
Experimental Group:Implanted AERD
Sponsors
Beijing Anzhen Hospital, Captial Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-90 2. Participants judged by the clinical investigator to be at high risk of surgery (EuroScore?6); or patients are judged unsuitable for surgery; and at any time risk of death due to malperfusion of organs or rupture of the aorta. 3.Caused by any reasons the first surgical procedure is performed only by Bentall but the residual aortic arch and distal dissection (almost) occlusion of the true luen or involvement of branch vessels resulting in malperfusion needs concurrent or postoperative. 4.Participants can understand the purpose of the cilnical trial and volunteer signed the ICF.
Exclusion criteria
Exclusion criteria: 1.Participants without suitable vascular access 2.Participants has a clear history of allergy to nickel-titanium alloy materials 3.Cannot be followed up on time 4.The aortic lesion has been ruptured and shock 5.Myocardial infarction or cerebrovascular accident occurred with in 30 days before implantation 6.Confirmed or suspected Marfan or have related family history 7.Participants with known contraindications to anticoagulants, antiplatelet agents or contrast agents; 9.Use to been or may be allergic to aspirin, clopidogrel, heparin, contrast agents, polylactic acid polymers and rapamycin; 10.Participants undergoing chemotherapy or planning to receive chemotherapy.Life expectancy less than 1 year 11.History of bleeding disorders or coagulation disorders. 12.Aortic fluffy syndrome 13.Takayasu arteritis 14.Pregnant or breastfeeding 15.Investigator judges that the participants has poor compliance and cannot complete the study as required, or the investigator believes that the patient is not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of new major complications associated with aortic dissection after surgery 30days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical success rate after surgery;Treatment success rate;Rupture of the aorta after surgery 30 days;Aortic true lumen remodeling results before leave hospital;Branchary vascular patency before leave hospital;AERD displacement before leave hospital;Transferred to the surgical group before leave hospital.(Not include patients are known to need surgery before surgery and aortic valve related); | — |
Countries
China
Contacts
Public ContactZhang Hongjia/Liu Yongmin/Ma Xiaohai
Beijing Anzhen Hospital.Captial Medical University
Outcome results
None listed