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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
420
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.
Xuanwu Hospital, Capital Medical University.
Beijing, China
RECRUITINGNumber of participants with ischemic stroke in territory of qualifying artery
Number of participants with ischemic stroke in territory of qualifying artery within 2 years after randomization
Time frame: 2 years after randomization
Number of participants with any stroke or death
Number of participants with any stroke or death within 30 days after randomization
Time frame: 30 days after randomization
A composite of any stroke or death within 30 days, or ischemic stroke in territory of qualifying artery beyond 30 days to 2 years after randomization
Number of participants with any stroke or death within 30 days, or ischemic stroke in territory of qualifying artery beyond 30 days to 2 years after randomization
Time frame: within 2 years after randomization
Number of participants with any stroke
Number of participants with any stroke within 2 years after randomization
Time frame: within 2 years after randomization
Number of participants with disabling stroke (mRS>3)
Number of participants with disabling stroke within 2 years after randomization
Time frame: within 2 years after randomization
Number of participants with fatal stroke (death caused by a stroke)
Number of participants with fatal stroke within 2 years after randomization
Time frame: within 2 years after randomization
Number of participants with death
Number of participants with death within 2 years after randomization
Time frame: within 2 years after randomization
Number of participants with any stroke or death
Number of participants with any stroke or death within 2 years after randomization
Time frame: within 2 years after randomization
Functional outcomes of participants
Functional outcomes of participants such as modified Rankin scale (mRS) or the National Institutes of Health Stroke Scale (NIHSS) at 2 years after randomization
Time frame: 2 years after randomization
Anastomosis patency of participants in surgical group
Anastomosis patency of participants in surgical group at 2 years after randomization
Time frame: 2 years after randomization
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