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

Last updated: March 24, 2025
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Recruiting

Phase

N/A

Condition

Occlusions

Treatment

Medical treatment alone

Extracranial-Intracranial Bypass Surgery

Clinical Study ID

NCT05899582
CMOSS-2
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age of 18-65 years;

  2. Confirmed as chronic occlusion of unilateral middle cerebral artery (MCA) by digitalsubtraction angiography (DSA) or computed tomography angiography (CTA). Othercerebral artery stenosis should be less than 50%.

  3. CT perfusion demonstrates severe hemodynamic insufficiency in the territory of thequalifying MCA with MTT (symptomatic side) ≥ 6s or rCBF (symptomaticside/contralateral side) ≤ 0.8;

  4. mRS score is 0-2 points;

  5. A history of ischemic events (including<1/2 cerebral infarction in the middlecerebral artery supply area, or transient ischemic attack [TIA]) related to thequalifying 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 thequalifying middle cerebral artery);

  8. Patients or their guardians voluntarily participate of the study and sign theconsent form.

Exclusion

Exclusion Criteria:

  1. History of intracranial hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, orextradural hemorrhage within 6 weeks;

  2. Unstable angina pectoris or myocardial infarction, congestive heart failure within 6months;

  3. Women who are pregnant or lactating;

  4. Coagulation dysfunction or hemorrhagic tendency (e.g. INR > 1.5 and/or plateletcount < 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 antiplateletdrugs.

  8. Known cardiac conditions that may lead to cardiogenic embolism: including prostheticvalves, infective endocarditis, left atrial or left ventricular thrombosis, atrialfibrillation, 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 othercontraindications 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 asitting 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/orglutamic 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, mayaffect the efficacy or safety evaluation of this study.

Study Design

Total Participants: 420
Treatment Group(s): 2
Primary Treatment: Medical treatment alone
Phase:
Study Start date:
September 15, 2023
Estimated Completion Date:
September 30, 2027

Study Description

Middle cerebral artery occlusion is an important cause of ischemic stroke, and there are currently two treatment methods: medical treatment alone and extracranial-intracranial bypass surgery (EC-IC bypass surgery). Previous studies have shown that the optimal medical treatment has an annual stroke recurrence rate of up to 10%, and patients with concomitant hemodynamic disorders can also increase by 7.3 times.

The CMOSS study was the first trial in China to evaluate the safety and efficacy of EC-IC bypass surgery on patients with ICA or MCA occlusion combined with hemodynamic insufficiency evaluated with CT perfusion. The results showed that there was no significant difference in the risk of stroke or death between the bypass group and the medical group, but there was a significant difference in ipsilateral ischemic stroke between 30 days and 2 years after randomization, with only 2.0% in the surgery group and 10.3% in the medical group; In addition, subgroup analysis found that for patients with MCA occlusion or severe hemodynamic insufficiency, bypass surgery has a potential beneficial trend over medical treatment alone.

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. The CMOSS-2 trial will be conducted in 13 sites in China.

Connect with a study center

  • Xuanwu Hospital, Capital Medical University.

    Beijing, 100053
    China

    Active - Recruiting

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