Tests bypass surgery plus medication against medication alone for a blocked brain artery

Trial details

Who runs it

Xuanwu Hospital, Beijing

Trial code

NCT05899582

Record updated

28 March 2025

Original description

The CMOSS-2 trial is a government-funded, prospective, multicenter, randomized controlled trial. It will recruit symptomatic chronic occlusion of the middle cerebral artery in patients with severe hemodynamic insufficiency. Only high-volume center with a proven track record will be included. Patients will be randomized (1:1) to best medical treatment alone or medical treatment plus bypass surgery. Primary outcome is ischemic stroke in the territory of the target artery within 24 months after randomization.Read full original descriptionShow less

Extracranial-intracranial Bypass Surgery Versus Medical Treatment Alone for Symptomatic Chronic Middle Cerebral Artery Occlusion: the CMOSS-2 Trial

The CMOSS-2 trial is a government-funded, prospective, multicenter, randomized controlled trial. It will recruit symptomatic chronic occlusion of the middle cerebral artery in patients with severe hemodynamic insufficiency. Only high-volume center with a proven track record will be included. Patients will be randomized (1:1) to best medical treatment alone or medical treatment plus bypass surgery. Primary outcome is ischemic stroke in the territory of the target artery within 24 months after randomization.

Inclusion: Age of 18-65 years; Confirmed as chronic occlusion of unilateral middle cerebral artery (MCA) by digital subtraction angiography (DSA) or computed tomography angiography (CTA). 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: Previous treatment with EC-IC bypass surgery; Having received a clinical trial drug or device within 30 days prior to screening, or being enrolled in another clinical trial; 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; Other diseases with a life expectancy of less than 2 years; Known allergy or contraindication to aspirin or clopidogrel or other antiplatelet drugs; Uncontrolled hypertension with a sitting systolic blood pressure >180 mmHg or a sitting diastolic blood pressure >110 mmHg; Active peptic ulcer disease; Other diseases or medical history that, in the judgment of the investigator, may affect the efficacy or safety evaluation of this study; Coagulation dysfunction or hemorrhagic tendency (e.g. INR > 1.5 and/or platelet count < 100,000 mcL); 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; Severe liver dysfunction, defined as serum alanine transaminase (ALT) and/or glutamic oxalacetic transaminase (AST) > 3 times the upper limit of normal range; Women who are pregnant or lactating; Persistent worsening of neurological symptoms within 72 hours.

ClinicalTrials.gov NCT05899582