Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT03516851
Eligibility Criteria:
Inclusion Criteria:
* Independent in activity of daily living(The modified Rankin Scale 0-2)
* At least one month since the most recent ischemic stroke
* The neurological deficit must be stable for more than 6 weeks
* Digital substraction angiography demonstrating progressive stenosis or occlusion in the terminal portion of the internal carotid artery and/or the initial portion of the anterior or middle cerebral arteries
* Digital substraction angiography demonstrating formation of abnormal collateral networks (moyamoya vessels) at the base of the brain, mainly in the region of thalamus and basal ganglia
* Digital substraction angiography demonstrating the vasculopathy appeared unilaterally or bilaterally
* Competent to give informed consent
* Accessible and reliable for follow-up
Exclusion Criteria:
* Other diseases(such as internal carotid artery stenosis, internal carotid artery dissection, atrial fibrillation, or Intracranial atherosclerosis) probably causing ischemic strokes
* Not independent in activity of daily living(The modified Rankin Scale 3-5)
* Moyamoya syndrome concomitant with other hereditary or autoimmune diseases (Grave's Disease,Type I Diabetes Mellitus,Type I Neurofibromatosis et al)
* Patient whose initial onset was marked by ischemia but subsequently suffered from intracranial hemorrhage
* Emergent evacuation of intracerebral hematoma damaging superficial temporal artery or cortical artery
* Emergent decompressive craniotomy causing automatically developed indirect revascularization
* Good collateral networks formed by spontaneous anastomosis between extracranial and intracranial vessels before surgery
* Life expectancy\<1 years
* Pregnancy
* Unstable angina or myocardial infarction with recent 6 months
* Blood coagulation dysfunction
* Allergic to iodine contrast agent
* Abnormal liver function(alanine transaminase (ALT) and/or aspartate aminotransferase (AST)\>3 times of normal range)
* Serum creatinine \>3mg/dl
* Poorly controlled hypertension (systolic BP\>160 mmHg,diastolic BP\>100 mmHg)
* Poor glucose control (fasting blood glucose\>16.7mmol/l)
* Concurrent participation in any other interventional clinical trial
* patients refused to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03516851
Study Brief:
Protocol Section:
NCT03516851