Extracranial-intracranial Bypass Surgery for Symptomatic Chronic Middle Cerebral Artery Occlusion: the CMOSS-2 Trial
Symptomatic Chronic Middle Cerebral Artery Occlusion, Infarction, Middle Cerebral Artery
About this trial
This is an interventional treatment trial for Symptomatic Chronic Middle Cerebral Artery Occlusion focused on measuring middle cerebral artery occlusion, stroke, TIA
Eligibility Criteria
Inclusion Criteria: Age of 18-65 years; Confirmed as chronic occlusion of unilateral middle cerebral artery (MCA) by angiography. Other cerebral artery stenosis should be less than 50%. CT perfusion demonstrates severe hemodynamic insufficiency in the territory of the qualifying MCA with MTT (symptomatic side) ≥ 6s or rCBF (symptomatic side/contralateral side) ≤ 0.8; mRS score is 0-2 points; A history of ischemic events (including<1/2 cerebral infarction in the middle cerebral artery supply area, or transient ischemic attack [TIA]) related to the qualifying artery within 12 months ; The onset of acute stroke should be more than 1 month; CT or MRI excludes large cerebral infarction (infarction>1/2 of the territory of the qualifying middle cerebral artery); Patients or their guardians voluntarily participate of the study and sign the consent form. Exclusion Criteria: History of intracranial hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or extradural hemorrhage within 6 weeks; Unstable angina pectoris or myocardial infarction, congestive heart failure within 6 months; Women who are pregnant or lactating; Coagulation dysfunction or hemorrhagic tendency (e.g. INR > 1.5 and/or platelet count < 100,000 mcL); Other diseases with a life expectancy of less than 2 years Previous treatment with EC-IC bypass surgery Known allergy or contraindication to aspirin or clopidogrel or other antiplatelet drugs. Known cardiac conditions that may lead to cardiogenic embolism: including prosthetic valves, infective endocarditis, left atrial or left ventricular thrombosis, atrial fibrillation, sick sinus node syndrome, atrial mucinous tumor or cardiomyopathy, ejection fraction <25%; Allergy to iodine or x-ray contrast, blood creatinine > 3.0 mg/dl or other contraindications to arteriography Uncontrolled diabetes mellitus with fasting blood sugar (FBS) >16.7 mmol/L Uncontrolled hypertension with a sitting systolic blood pressure >180 mmHg or a sitting diastolic blood pressure >110 mmHg; Persistent worsening of neurological symptoms within 72 hours; Severe liver dysfunction, defined as serum alanine transaminase (ALT) and/or glutamic oxalacetic transaminase (AST) > 3 times the upper limit of normal range; Active peptic ulcer disease; Having received a clinical trial drug or device within 30 days prior to screening, or being enrolled in another clinical trial; Other diseases or medical history that, in the judgment of the investigator, may affect the efficacy or safety evaluation of this study.
Sites / Locations
- Xuanwu Hospital, Capital Medical University.Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Surgery
Medical treatment
The patients in the surgical group will be treated with direct extracranial to intracranial bypass surgery plus best medical treatment.
The patients will receive medical treatment alone according to the AHA/ASA Stroke and Transient Ischemic Attack (TIA) Stroke Prevention Guidelines (2021 edition).