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

Launched by XUANWU HOSPITAL, BEIJING · Jun 9, 2023

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ClinConnect Summary

The CMOSS-2 trial is studying the effects of bypass surgery for patients with a blocked middle cerebral artery, which can lead to symptoms like strokes. This trial aims to find out if adding surgery to the best medical treatment can help prevent strokes in these patients. To participate, individuals must be between 18 and 65 years old, have a confirmed blockage of the middle cerebral artery, and have experienced related symptoms in the past year. They should also have certain test results indicating poor blood flow in the affected area.

Participants in this trial will be randomly assigned to either receive only the best medical treatment or the medical treatment plus bypass surgery. The main goal is to see if the surgery can reduce the risk of strokes in the following two years. It’s important to know that not everyone can join; those with certain health issues, like recent heart problems or specific blood disorders, will be excluded. This trial is currently recruiting participants from high-volume medical centers that have experience with similar cases. If you or someone you know might be eligible, discussing this with a healthcare provider could be a good next step.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age of 18-65 years;
• • 2. 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%.
• • 3. 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;
• • 4. mRS score is 0-2 points;
• • 5. 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 ;
• • 6. The onset of acute stroke should be more than 1 month;
• • 7. CT or MRI excludes large cerebral infarction (infarction\>1/2 of the territory of the qualifying middle cerebral artery);
• • 8. Patients or their guardians voluntarily participate of the study and sign the consent form.
• Exclusion Criteria:
• • 1. History of intracranial hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or extradural hemorrhage within 6 weeks;
• • 2. Unstable angina pectoris or myocardial infarction, congestive heart failure within 6 months;
• • 3. Women who are pregnant or lactating;
• • 4. Coagulation dysfunction or hemorrhagic tendency (e.g. INR \> 1.5 and/or platelet count \< 100,000 mcL);
• • 5. Other diseases with a life expectancy of less than 2 years
• • 6. Previous treatment with EC-IC bypass surgery
• • 7. Known allergy or contraindication to aspirin or clopidogrel or other antiplatelet drugs.
• • 8. 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%;
• • 9. Allergy to iodine or x-ray contrast, blood creatinine \> 3.0 mg/dl or other contraindications to arteriography
• • 10. Uncontrolled diabetes mellitus with fasting blood sugar (FBS) \>16.7 mmol/L
• • 11. Uncontrolled hypertension with a sitting systolic blood pressure \>180 mmHg or a sitting diastolic blood pressure \>110 mmHg;
• • 12. Persistent worsening of neurological symptoms within 72 hours;
• • 13. Severe liver dysfunction, defined as serum alanine transaminase (ALT) and/or glutamic oxalacetic transaminase (AST) \> 3 times the upper limit of normal range;
• • 14. Active peptic ulcer disease;
• • 15. Having received a clinical trial drug or device within 30 days prior to screening, or being enrolled in another clinical trial;
• • 16. Other diseases or medical history that, in the judgment of the investigator, may affect the efficacy or safety evaluation of this study.