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New treatment option for Symptomatic Chronic Middle Cerebral Artery Occlusion
Official title Extracranial-intracranial Bypass Surgery for Symptomatic Chronic Middle Cerebral Artery Occlusion: the CMOSS-2 Trial
ClinicalTrials.gov ID: NCT05899582
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- CT perfusion demonstrates severe hemodynamic insufficiency in the territory of the qualifying MCA with MTT (symptomatic side) ≥ 6s or rCBF...
- 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])...
You likely can't join 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
See the full eligibility criteria
- 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.
- 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...
- 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 how well it works or safety evaluation of this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.