Stanford type B dissection near the left subclavian artery
Conditions
Interventions
Sponsors
PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-80 years old, regardless of gender; 2. Be able to understand the purpose of the trial, participate in the study voluntarily, the subject himself or his legal representative signs the informed consent, and is willing to complete the follow-up according to the requirements of the scheme; 3. Patients with Stanford type B aortic dissection who need to reconstruct the blood supply of left subclavian artery; 4. The diameter of the proximal anchorage area (the aorta at the posterior edge of the left common carotid opening) was 18-42mm; 5. The length of proximal anchorage area (the distance from the posterior edge of left common carotid artery to the first breach) >= 15mm; 6. The distance between left common carotid artery and left subclavian artery >= 5mm; 7. The distance between the left vertebral artery and the left subclavian artery was >= 15 mm, and the diameter of the left subclavian artery was 6-20 mm; 8. Patients with suitable approach of femoral artery, iliac artery and brachial artery can be treated by intra aortic approach.
Exclusion criteria
Exclusion criteria: 1. Patients who are unable to use contraception during pregnancy or lactation or during the trial; 2. Patients who have participated in clinical trials of other drugs or devices in the same period; 3. Patients with other vascular diseases (such as coronary artery, renal artery, mesenteric artery, etc.) need to be intervened in the same operation and the postoperative drug treatment plan is affected; 4. Patients with a history of aortic surgery or endovascular repair; 5. Patients who are allergic to contrast agents, anesthetics, stents and conveyor materials; 6. Patients unable to tolerate anesthesia; 7. Patients with severe liver, kidney, lung and heart dysfunction before operation [subjects whose serum creatinine exceeds 2 times the upper limit of the normal value; subjects whose ALT or ast exceeds 5 times the upper limit of the normal value; subjects whose serum total bilirubin (STB) exceeds 2 times the upper limit of the normal value; subjects whose left ventricular ejection fraction is lower than the normal value indicated by color Doppler echocardiography]; 8. Patients with true or false thoracic aortic aneurysm; 9. Patients with history of myocardial infarction, transient ischemic attack (TIA) or cerebral infarction in the past 3 months; 10. Patients with contraindications to antiplatelet drugs and anticoagulants; 11. Patients whose life expectancy is less than 12 months (such as advanced cancer); 12. Patients with acute systemic infection; 13. The patients with severe stenosis or calcification in the anchorage area near the stent are easy to lead to the difficulty of stent placement; 14. Patients who were judged by the researchers to be unsuitable for intracavitary treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| successful rate of aortic dissection treatment 12 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| the incidence of leakage (type I or III);the incidence of stent migration;feeder vessel patency rate;successful rate of aortic dissection vascular remodeling; | — |
Countries
China
Contacts
Public ContactZhang Mengsha
Hangzhou Weiqiang Medical Technology Co., Ltd.
Outcome results
None listed