Stanford type B aortic dissection
Conditions
Interventions
Experimental group: Cratos branch aortic covered stent system
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Non-pregnant or lactating subjects aged 18 to 85 years; 2. Subjects diagnosed with Stanford type B aortic dissection; 3. The proximal rupture was between 15mm distal of the left common carotid artery and 20mm distal of the left subclavian artery (LSA), or the dissection was reversely torn to LSA; 4. Subjects who are suitable for endovascular treatment as judged by the investigator; 5. Subjects who can understand the purpose of the trial, participate voluntarily and sign the informed consent, and are willing to follow up.
Exclusion criteria
Exclusion criteria: 1. Lesions involved zone 0 and zone 1; 2. The patient was diagnosed with aortic connective tissue disease (such as Marfan syndrome); 3. The patient has a clear history of allergy to Nitinol materials and contrast media; 4. Severe liver and kidney dysfunction (alanine aminotransferase or aspartate aminotransferase 2.5 times higher than the upper limit of normal, serum creatinine 2 times higher than the upper limit of normal); 5. Uncontrollable infections, such as bacteremia or toxemia; 6. Patients with malignant tumors and a life expectancy of less than 12 months; 7. The patient is participating in a clinical trial of another drug or medical device and has not completed the primary endpoint of the study; 8. Patients have poor compliance and are not expected to follow up on time; 9. Other cases judged by the investigator to be inappropriate for endovascular treatment, such as lack of appropriate vascular approach and failure to cooperate, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major adverse events (MAE) within 30 days;Success rate in 30 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate technical success rate;Clinical success rate (years 1-5);All-cause mortality (30 days, 6 months, 1-5 years);Mortality associated with aortic dissection (30 days, 6 months, 1-5 years);Incidence of neurological complications (30 days, 6 months, 1-5 years);Patency rate of branch stents (30 days, 6 months, 1-5 years);Incidence of secondary intervention (30 days, 6 months, 1-5 years);Incidence of endoleak (30 days, 6 months, 1-5 years);Rate of complete thrombosis of false lumen in aortic dissection (year 1-5);Maximum diameter of aortic dissection plane ring aortic diameter, true and false lumen diameter, and diameter change (30 days, 6 months, 1-5 years);Incidence of major adverse events (6 months, year 1-5); | — |
Countries
China
Contacts
Public ContactLu Qingsheng
Shanghai Changhai Hospital
Outcome results
None listed