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

NCT05899582 | Recruiting DMC

• 1 other identifier: CMOSS-2
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Chronic Middle Cerebral Artery Occlusion; Infarction, Middle Cerebral Artery

Keywords

middle cerebral artery occlusion; stroke; TIA

Outcome Measures

Primary Outcomes (1)

• Number 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

  2 years after randomization

Secondary Outcomes (9)

• Number of participants with any stroke or death

  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

  within 2 years after randomization

• Number of participants with any stroke

  within 2 years after randomization

• Number of participants with disabling stroke (mRS>3)

  within 2 years after randomization

• Number of participants with fatal stroke (death caused by a stroke)

  within 2 years after randomization

Study Arms (2)

Surgery

EXPERIMENTAL

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

Medical treatment

ACTIVE COMPARATOR

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

Interventions

Extracranial-Intracranial Bypass Surgery PROCEDURE

Extracranial-intracranial bypass surgery plus medical treatment

Surgery

Medical treatment alone OTHER

Best medical treatment alone according to current clinical guidelines, including antiplatelet drugs (e.g. aspirin) and risk factor controls.

Also known as: Best medical treatment

Medical treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of intracranial hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or extradural hemorrhage within 6 weeks;
• Unstable angina pectoris or myocardial infarction, congestive heart failure within 6 months;
• Women who are pregnant or lactating;
• Coagulation dysfunction or hemorrhagic tendency (e.g. INR \> 1.5 and/or platelet count \< 100,000 mcL);
• 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%;
• Allergy to iodine or x-ray contrast, blood creatinine \> 3.0 mg/dl or other contraindications to arteriography
• Uncontrolled diabetes mellitus with fasting blood sugar (FBS) \>16.7 mmol/L
• Uncontrolled hypertension with a sitting systolic blood pressure \>180 mmHg or a sitting diastolic blood pressure \>110 mmHg;
• Persistent worsening of neurological symptoms within 72 hours;
• Severe liver dysfunction, defined as serum alanine transaminase (ALT) and/or glutamic oxalacetic transaminase (AST) \> 3 times the upper limit of normal range;
• Active peptic ulcer disease;
• Having received a clinical trial drug or device within 30 days prior to screening, or being enrolled in another clinical trial;

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University.

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Infarction, Middle Cerebral Artery; Stroke

Condition Hierarchy (Ancestors)

Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Liqun Jiao, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Ma, MD

CONTACT

13810669502; leavesyan@sina.com

Tao Wang, MD

CONTACT

18810302298; wangtao_dr@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 12, 2023
• Study Start: September 15, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)