Aortic Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient's aged >=18 years old, male or non pregnant female; 2. Patients diagnosed as aortic dissection and suitable for the use of Castor branched aortic stent graft system; 3. The proximal rupture was between 15 mm distal of left common carotid artery and 20 mm distal of left subclavian artery (LSA), or the dissection was reversed to LSA; 4. Patients can understand the purpose of the study, voluntarily participate in and sign the informed consent; 5. Patients are willing to follow up and evaluate according to the requirements of the study plan.
Exclusion criteria
Exclusion criteria: 1. The lesions involved zone 0 and zone 1; 2. The patient was definitely diagnosed as connective tissue disease (such as Marfan syndrome); 3. The patient has a clear history of allergy to nitinol alloy; 4. The patient has or may have serious allergic reaction to the contrast medium; 5. The patient's compliance is poor and the follow-up is not expected on time; 6. The life expectancy of patients is less than 12 months. (if any of the above criteria is met, it cannot be selected)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate after 12 month; | — |
Secondary
| Measure | Time frame |
|---|---|
| technical successful rate;Mortality associated with aortic dissection;endoleak rate;Rate of aortic rupture;Incidence of neurological complications;Incidence of stent displacement in 6 and 12 months after operation;Incidence of branch stenosis and occlusion in 6 and 12 months after operation;Unplanned stent implantation rate during operation;Reoperation rate;Conversion rate to open surgery;30 day major adverse event (MAE) incidence;Incidence of device related adverse events; | — |
Countries
China
Contacts
Department of Cardiovascular Surgery, Renji Hospital,Shanghai Jiao Tong University School of Medicine