Phase
Condition
Occlusions
Treatment
Medical treatment alone
Extracranial-Intracranial Bypass Surgery
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age of 18-65 years;
Confirmed as chronic occlusion of unilateral middle cerebral artery (MCA) by digitalsubtraction angiography (DSA) or computed tomography angiography (CTA). Othercerebral artery stenosis should be less than 50%.
CT perfusion demonstrates severe hemodynamic insufficiency in the territory of thequalifying MCA with MTT (symptomatic side) ≥ 6s or rCBF (symptomaticside/contralateral side) ≤ 0.8;
mRS score is 0-2 points;
A history of ischemic events (including<1/2 cerebral infarction in the middlecerebral artery supply area, or transient ischemic attack [TIA]) related to thequalifying 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 thequalifying middle cerebral artery);
Patients or their guardians voluntarily participate of the study and sign theconsent form.
Exclusion
Exclusion Criteria:
History of intracranial hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, orextradural hemorrhage within 6 weeks;
Unstable angina pectoris or myocardial infarction, congestive heart failure within 6months;
Women who are pregnant or lactating;
Coagulation dysfunction or hemorrhagic tendency (e.g. INR > 1.5 and/or plateletcount < 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 antiplateletdrugs.
Known cardiac conditions that may lead to cardiogenic embolism: including prostheticvalves, infective endocarditis, left atrial or left ventricular thrombosis, atrialfibrillation, 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 othercontraindications 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 asitting diastolic blood pressure >110 mmHg;
Persistent worsening of neurological symptoms within 72 hours;
Severe liver dysfunction, defined as serum alanine transaminase (ALT) and/orglutamic 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, mayaffect the efficacy or safety evaluation of this study.
Study Design
Study Description
Connect with a study center
Xuanwu Hospital, Capital Medical University.
Beijing, 100053
ChinaActive - Recruiting
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