Bypass surgery for chronic middle cerebral artery occlusion

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

This study is testing if bypass surgery can help people with blocked middle cerebral arteries avoid strokes better than just taking medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05899582 on ClinicalTrials.gov

What this trial studies

The CMOSS-2 trial is a multicenter, randomized controlled trial that investigates the effectiveness of extracranial-intracranial bypass surgery compared to best medical treatment alone for patients with symptomatic chronic middle cerebral artery occlusion and severe hemodynamic insufficiency. Participants will be randomly assigned to receive either the surgical intervention or medical management, with the primary outcome being the incidence of ischemic stroke in the affected artery within 24 months. This trial aims to provide insights into the potential benefits of surgical intervention in reducing stroke risk for this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with confirmed chronic occlusion of the middle cerebral artery and severe hemodynamic insufficiency.

Not a fit: Patients with large cerebral infarctions or those with significant stenosis in other cerebral arteries may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could significantly reduce the risk of ischemic stroke in patients with chronic middle cerebral artery occlusion.

How similar studies have performed: Previous studies have shown promising trends for surgical intervention in similar patient populations, although the CMOSS study indicated no significant difference in overall stroke risk.

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.

Where this trial is running

Beijing

• Xuanwu Hospital, Capital Medical University. — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Liqun Jiao, MD — Xuanwu Hospital, Beijing
• Study coordinator: Yan Ma, MD

Conditions Symptomatic Chronic Middle Cerebral Artery Occlusion; Infarction, Middle Cerebral Artery; middle cerebral artery occlusion; stroke; TIA