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

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ClinicalTrials.gov Identifier: NCT05899582
Recruitment Status : Recruiting
First Posted : June 12, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Symptomatic Chronic Middle Cerebral Artery Occlusion Infarction, Middle Cerebral Artery Procedure: Extracranial-Intracranial Bypass Surgery Other: Medical treatment alone Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extracranial-intracranial Bypass Surgery Versus Medical Treatment Alone for Symptomatic Chronic Middle Cerebral Artery Occlusion: the CMOSS-2 Trial
Actual Study Start Date : September 15, 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: Surgery
The patients in the surgical group will be treated with direct extracranial to intracranial bypass surgery plus best medical treatment.
 Procedure: Extracranial-Intracranial Bypass Surgery
Extracranial-intracranial bypass surgery plus medical treatment
Active Comparator: Medical treatment
The patients will receive medical treatment alone according to the AHA/ASA Stroke and Transient Ischemic Attack (TIA) Stroke Prevention Guidelines (2021 edition).
 Other: Medical treatment alone
Best medical treatment alone according to current clinical guidelines, including antiplatelet drugs (e.g. aspirin) and risk factor controls.
Other Name: Best medical treatment


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with ischemic stroke in territory of qualifying artery [ Time Frame: 2 years after randomization ]
    Number of participants with ischemic stroke in territory of qualifying artery within 2 years after randomization


Secondary Outcome Measures :
  1. Number of participants with any stroke or death [ Time Frame: 30 days after randomization ]
    Number of participants with any stroke or death within 30 days after randomization

  2. 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 [ Time Frame: within 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

  3. Number of participants with any stroke [ Time Frame: within 2 years after randomization ]
    Number of participants with any stroke within 2 years after randomization

  4. Number of participants with disabling stroke (mRS>3) [ Time Frame: within 2 years after randomization ]
    Number of participants with disabling stroke within 2 years after randomization

  5. Number of participants with fatal stroke (death caused by a stroke) [ Time Frame: within 2 years after randomization ]
    Number of participants with fatal stroke within 2 years after randomization

  6. Number of participants with death [ Time Frame: within 2 years after randomization ]
    Number of participants with death within 2 years after randomization

  7. Number of participants with any stroke or death [ Time Frame: within 2 years after randomization ]
    Number of participants with any stroke or death within 2 years after randomization

  8. Functional outcomes of participants [ Time Frame: 2 years after randomization ]
    Functional outcomes of participants such as modified Rankin scale (mRS) or the National Institutes of Health Stroke Scale (NIHSS) at 2 years after randomization

  9. Anastomosis patency of participants in surgical group [ Time Frame: 2 years after randomization ]
    Anastomosis patency of participants in surgical group at 2 years after randomization


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of 18-65 years;
  2. Confirmed as chronic occlusion of unilateral middle cerebral artery (MCA) by angiography. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05899582


Contacts
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Contact: Yan Ma, MD 13810669502 leavesyan@sina.com
Contact: Tao Wang, MD 18810302298 wangtao_dr@sina.com

Locations
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China
Xuanwu Hospital, Capital Medical University. Recruiting
Beijing, China, 100053
Contact: Liqun Jiao, MD    13911224991    liqunjiao@sina.cn   
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Principal Investigator: Liqun Jiao, MD Xuanwu Hospital, Beijing
More Information
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Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT05899582    
Other Study ID Numbers: CMOSS-2
First Posted: June 12, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xuanwu Hospital, Beijing:
middle cerebral artery occlusion
stroke
TIA
Additional relevant MeSH terms:
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Infarction, Middle Cerebral Artery
Arterial Occlusive Diseases
Infarction
Ischemia
Pathologic Processes
Necrosis
Vascular Diseases
Cardiovascular Diseases
Cerebral Infarction
 Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Stroke