intracranial artherosclerosis disease
Conditions
Interventions
Surgical group:Precise extracranial-intracranial vascular bypass surgery + standard medical therapy. Subjects in the surgical group should complete preoperative examinations, complete surgery within 7
Medical therapy group:Standard medical therapy. After randomization, subjects in the medical therapy group should receive antiplatelet therapy combined with statin therapy according to the treatment r
Sponsors
Huashan Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 65 years old. 2. Cerebral angiography-confirmed chronic unilateral internal carotid artery or middle cerebral artery occlusion. If there is other cerebral blood-supplying artery stenosis, the degree of stenosis should be less than 50%; 3. CT perfusion imaging (CTP) indicates that the mean transit time (MTT) contrast agent is > 6s or regional cerebral blood flow (rCBF) is decreased by 1/2 of the middle cerebral artery territory); 8. Female patients must be non-pregnant and not plan to become pregnant during the trial duration. 9. Patients who have signed the informed consent form
Exclusion criteria
Exclusion criteria: 1. Patients complicated with hemorrhagic vascular disease, such as intracranial aneurysm or vascular malformation, or scheduled for other cerebrovascular surgery that may alter cerebral hemodynamics or lead to stroke; 2. Patients with unstable angina or myocardial infarction, congestive heart failure (NYHA cardiac function Class >=III or ejection fraction 16.7 mmol/L; 10. Hypertension inadequately controlled (sitting systolic pressure > 180 mmHg or sitting diastolic pressure > 110 mmHg); 11. Continuous aggravation and worsening of neurological symptoms within 72 hours before inclusion; 12. Severe hepatic dysfunction, defined as serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 times the upper limit of normal; 13. Active peptic ulcer disease; 14. Platelet count <100 × 10^9/L; 15. Patients who have been treated with another clinical investigational drug or investigational device within 30 days prior to screening, or are participating in another clinical trial; 16. Subjects with other conditions that are considered by the investigator as inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any symptomatic stroke/death within 30 days after randomization or symptomatic ischemic stroke in the responsible vessel from 30 days to 24 months after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Any stroke/death within 30 days after randomization;Ischemic stroke in the responsible vessel from 30 days to 24 months after randomization;Ischemic stroke in the responsible vessel within 24 months after randomization;Any stroke within 24 months;Disabling stroke within 24 months;Fatal stroke within 24 months;Death within 24 months;Any stroke or death within 24 months;9) Functional outcome scores at Month 24 after randomization, including mRS And NIHSS;10) Vascular anastomosis patency rate within 24 months after operation in the surgical group;11) Surgery-related complications; | — |
Countries
China
Contacts
Public ContactYuxiang Gu
Huashan Hospital of Fudan University
Outcome results
None listed