Symptomatic Chronic Middle Cerebral Artery OcclusionNCT05899582
Extracranial-intracranial Bypass Surgery for Symptomatic Chronic Middle Cerebral Artery Occlusion: the CMOSS-2 Trial
A study testing Extracranial-Intracranial Bypass Surgery and Medical treatment alone in people with Symptomatic Chronic Middle Cerebral Artery Occlusion and Infarction, Middle Cerebral Artery, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Symptomatic Chronic Middle Cerebral Artery Occlusion, Infarction, Middle Cerebral Artery
- What is being tested?
- Extracranial-Intracranial Bypass Surgery and Medical treatment alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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;
- Other diseases or medical history that, in the judgment of the investigator, may affect the efficacy or safety evaluation of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University.
Beijing, 100053
Liqun Jiao, MD, 13911224991, liqunjiao@sina.cn
About this study
Official title: Extracranial-intracranial Bypass Surgery Versus Medical Treatment Alone for Symptomatic Chronic Middle Cerebral Artery Occlusion: the CMOSS-2 Trial
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.
Read the 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.
- Being tested
- Extracranial-Intracranial Bypass Surgery, Medical treatment alone
- Keywords
- middle cerebral artery occlusion, stroke, TIA
- Medical subject headings
- Infarction, Middle Cerebral Artery, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracranial-Intracranial Bypass SurgeryProcedure or surgery
Extracranial-intracranial bypass surgery plus medical treatment
Medical treatment aloneOther
Also called Best medical treatment
Best medical treatment alone according to current clinical guidelines, including antiplatelet drugs (e.g. aspirin) and risk factor controls.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | The patients in the surgical group will be treated with direct extracranial to intracranial bypass surgery plus best medical treatment. Receives: 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). Receives: Other: Medical treatment alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years after randomization
Secondary outcomes (9)
Number of participants with any stroke or death
Number of participants with any stroke or death within 30 days after randomization
Measured: 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
Measured: within 2 years after randomization
Number of participants with any stroke
Number of participants with any stroke within 2 years after randomization
Measured: within 2 years after randomization
Number of participants with disabling stroke (mRS>3)
Number of participants with disabling stroke within 2 years after randomization
Measured: 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
Measured: within 2 years after randomization
Number of participants with death
Number of participants with death within 2 years after randomization
Measured: 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
Measured: 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
Measured: 2 years after randomization
Anastomosis patency of participants in surgical group
Anastomosis patency of participants in surgical group at 2 years after randomization
Measured: 2 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start15 Sep 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Chronic Middle Cerebral Artery OcclusionStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liqun Jiao, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899582
- Sponsor's protocol ID
- CMOSS-2
- Status last verified
- Mar 2025
- First submitted
- 23 May 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracranial-intracranial Bypass Surgery Versus Medical Treatment Alone for Symptomatic Chronic Middle Cerebral Artery Occlusion: the CMOSS-2 Trial
- ClinicalTrials.gov ID
- NCT05899582
- Acronym / sponsor ID
- CMOSS-2
- Keywords
- middle cerebral artery occlusion, stroke, TIA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Extracranial-Intracranial Bypass SurgeryThe patients in the surgical group will be treated with direct extracranial to intracranial bypass surgery plus best medical treatment. |
| Medical treatment | Active comparator | Other: Medical treatment aloneThe patients will receive medical treatment alone according to the AHA/ASA Stroke and Transient Ischemic Attack (TIA) Stroke Prevention Guidelines (2021 edition). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 ;
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracranial-Intracranial Bypass SurgeryExtracranial-intracranial bypass surgery plus medical treatment | Procedure or surgery | Surgery |
| Medical treatment aloneAlso: Best medical treatmentBest medical treatment alone according to current clinical guidelines, including antiplatelet drugs (e.g. aspirin) and risk factor controls. | Other | Medical treatment |
Primary outcome
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
9 secondary outcomes
Number of participants with any stroke or death
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
Time frame: within 2 years after randomization
Number of participants with any stroke
Time frame: within 2 years after randomization
Number of participants with disabling stroke (mRS>3)
Time frame: within 2 years after randomization
Number of participants with fatal stroke (death caused by a stroke)
Time frame: within 2 years after randomization
Number of participants with death
Time frame: within 2 years after randomization
Number of participants with any stroke or death
Time frame: within 2 years after randomization
Functional outcomes of participants
Time frame: 2 years after randomization
Anastomosis patency of participants in surgical group
Time frame: 2 years after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liqun Jiao, MD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracranial-Intracranial Bypass Surgery and Medical treatment alone in people with Symptomatic Chronic Middle Cerebral Artery Occlusion and Infarction, Middle Cerebral Artery, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Ma, MD (13810669502, leavesyan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with ischemic stroke in territory of qualifying artery (time frame: 2 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.