Actively Recruiting
Extracranial-intracranial Bypass Surgery for Symptomatic Chronic Middle Cerebral Artery Occlusion: the CMOSS-2 Trial
Led by Xuanwu Hospital, Beijing · Updated on 2025-03-28
420
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Extracranial-intracranial Bypass Surgery for Symptomatic Chronic Middle Cerebral Artery Occlusion: the CMOSS-2 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18-65 years
- Confirmed chronic occlusion of unilateral middle cerebral artery (MCA) by digital subtraction angiography or computed tomography angiography with less than 50% stenosis in other cerebral arteries
- Severe hemodynamic insufficiency in the affected MCA territory shown by CT perfusion with MTT 26 6 seconds or rCBF 24 0.8
- Modified Rankin Scale (mRS) score of 0 to 2
- History of ischemic events related to the affected artery within the past 12 months, including less than half cerebral infarction in MCA territory or transient ischemic attack
- Acute stroke onset more than 1 month prior
- No large cerebral infarction (less than half the MCA territory) on CT or MRI
- Voluntary participation and signed consent form
You will not qualify if you...
- History of intracranial hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or extradural hemorrhage within 6 weeks
- Unstable angina, myocardial infarction, or congestive heart failure within 6 months
- Pregnant or lactating women
- Coagulation disorders or bleeding tendency (INR > 1.5 or platelet count < 100,000 mcL)
- Other diseases with life expectancy less than 2 years
- Previous extracranial-intracranial bypass surgery
- Allergy or contraindication to aspirin, clopidogrel, or other antiplatelet drugs
- Cardiac conditions causing embolism risk (prosthetic valves, endocarditis, atrial fibrillation, etc.) with ejection fraction < 25%
- Allergy to iodine or contrast agents, blood creatinine > 3.0 mg/dl, or contraindications to arteriography
- Uncontrolled diabetes with fasting blood sugar > 16.7 mmol/L
- Uncontrolled hypertension with systolic > 180 mmHg or diastolic > 110 mmHg
- Persistent worsening of neurological symptoms within 72 hours
- Severe liver dysfunction (ALT or AST > 3 times normal)
- Active peptic ulcer disease
- Participation in another clinical trial or use of trial drug/device within 30 days
- Other medical conditions judged by investigators to affect safety or efficacy evaluation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University.
Beijing, China, 100053
Actively Recruiting
Research Team
Y
Yan Ma, MD
CONTACT
T
Tao Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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