Stanford type B aortic dissection
Conditions
Interventions
Group of participants with thoracic endovaScular aortic repair (single-branced stent-graft/Chimney/fenestration/hybrid):None
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: All of the following 4 items need to be met to be enrolled: 1. Age >=18 years, male or female; 2. Diagnosis of Stanford type B aortic dissection; 3. Proximal entry tear <15 mm distal to the ostium of the left subclavian artery or retrogradely involved the left subclavian artery, with Zone 2 proximal landing zone; 4. Understand the purpose of the trial, voluntarily participate in the trial, sign the informed consent form, and be willing to follow up.
Exclusion criteria
Exclusion criteria: 1. Lesions involving Zone 2 and its proximal region, and the proximal landing zone should be extended to Zone 0 or Zone 1; 2. Diagnosed with aortic-related connective tissue disease (e.g., Marfan syndrome, etc.); 3. Allergic to nickel-titanium alloy materials, contrast agents, etc.; 4. Severe hepatic and renal dysfunction (alanine aminotransferase or aspartate aminotransferase 2.5 times higher than the upper limit of normal and serum creatinine 2 times higher than the upper limit of normal); 5. Uncontrolled severe infection such as bacteraemia or toxaemia; 6. During pregnancy or lactation; 7. Subjects who are participating in another drug or medical device clinical trial and have not completed the primary study endpoint of that study; 8. Poor patient compliance and not expected to complete follow-up on time; 9. Other circumstances judged by the investigator to be unsuitable for endovascular repair, such as no suitable vascular access, inability to cooperate, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Benign reconstruction 1 year after the operation;Incidence of major adverse events within 30 days after the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Freedom from aortic-related death;Freedom from death;Freedom from reintervention;Freedom from dSINE;Freedom from RTAD;Freedom from type I/III endoleak;Freedom from LSA occlusion;Incidence of left upper limb ischemia symptoms;Technical success rate; | — |
Countries
China
Contacts
Public ContactQingsheng Lu
Shanghai Changhai Hospital
Outcome results
None listed