Extracranial-intracranial Bypass Surgery for Symptomatic Chronic Middle Cerebral Artery Occlusion… (NCT05899582) | Clinical Trial Compass
RecruitingNot Applicable
Extracranial-intracranial Bypass Surgery for Symptomatic Chronic Middle Cerebral Artery Occlusion: the CMOSS-2 Trial
China420 participantsStarted 2023-09-15
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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 criteria
What they're measuring
1
Number of participants with ischemic stroke in territory of qualifying artery
✕. 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%;