Extracranial-intracranial Bypass Surgery for Symptomatic Chronic Middle Cerebral Artery Occlusion: the CMOSS-2 Trial
Extracranial-intracranial Bypass Surgery Versus Medical Treatment Alone for Symptomatic Chronic Middle Cerebral Artery Occlusion: the CMOSS-2 Trial
Xuanwu Hospital, Beijing
420 participants
Sep 15, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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 Criteria16
- 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.
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Interventions
Extracranial-intracranial bypass surgery plus medical treatment
Best medical treatment alone according to current clinical guidelines, including antiplatelet drugs (e.g. aspirin) and risk factor controls.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05899582