Bypass surgery for chronic middle cerebral artery occlusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Xuanwu Hospital, Capital Medical University.
  Beijing, China Recruiting

Study contacts

• Principal investigator: Liqun Jiao, MD — Xuanwu Hospital, Beijing
• Study coordinator: Yan Ma, MD
• Email: leavesyan@sina.com
• Phone: 13810669502

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Acoustic Stimulation During Sleep for Alzheimer’s Disease

  Researchers test whether playing gentle sounds during sleep can help people with Alzheimer’s disease see if their thinking improves compared with a sham sound.

  Recruiting Xuanwu Hospital, Beijing · Beijing · NCT07924657

• See if multimodal biomarkers can map changes from mild cognitive impairment to dementia

  This observational study tests whether clinical, blood, and brain-imaging markers can tell apart stages of cognitive decline and predict progression from mild cognitive impairment to dementia in about 600 people.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT07876570

• Satralizumab in the early treatment of NMOSD attacks: a multicenter real-world study

  This study tests whether starting Satralizumab during an NMOSD attack is safe and helpful for adults with AQP4-IgG–positive NMOSD.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT07762872

• Real-World Experience With the WEB Device for Intracranial Aneurysms

  This study tests how well the Woven EndoBridge device works in routine treatment of intracranial aneurysms in China across multiple centers.

  Recruiting Xuanwu Hospital, Beijing · Beijing · NCT07620626

• Multicenter Registry of Intracranial Dural Arteriovenous Fistulas in China

  This study will collect and analyze data from many hospitals in China to see how common intracranial dural AV fistulas are, how they’re treated, and what outcomes look like for patients.

  Recruiting Xuanwu Hospital, Beijing · Beijing · NCT07604688

• Preventive Analgesia With Anrikefon in Laparoscopic Gallbladder Surgery

  This study tests whether giving Anrikefon before or during laparoscopic cholecystectomy can reduce early postoperative pain.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT07566663

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.