This trial is active, not recruiting.

Conditions moyamoya, stroke
Treatment extracranial-intracranial bypass surgery
Phase phase 3
Sponsor Huashan Hospital
Start date May 2015
End date May 2023
Trial size 360 participants
Trial identifier NCT02319980, CAHMD 2014


The aim of this study is to investigate whether extracranial-intracranial(EC-IC) bypass surgery could prevent rebleeding and improve neurological function in adult moyamoya with hemorrhagic onset.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
All participants in this group will be assigned to receive extracranial-intracranial arterial bypass surgery.
extracranial-intracranial bypass surgery STA-MCA Bypass and EDMS
All participants in this group will undergo combined cerebral revascularization surgery,namely superficial temporal to middle cerebral artery bypass (STA-MCA) and encephalo-duro-myo-synangiosis(EDMS)
(No Intervention)
All participants in this group will be assigned to receive conservative management or medical management which involves drug therapy as considered appropriate for medical symptoms by the treating investigator.

Primary Outcomes

All strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards
time frame: within 5 years of randomization

Secondary Outcomes

All kinds of adverse events related to surgery
time frame: up to 30 days
Rebleeding on the contralateral side
time frame: up to 5 years
Transient ischemic attack on the surgically treated side
time frame: up to 5 years
The changes from baseline in modified Rankin Scale (mRS)
time frame: at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial
The changes from baseline in National Institute of Health Stroke Scale (NIHSS)
time frame: at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial
The changes from baseline in modified Barthel Index
time frame: at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: 1. Independent in activity of daily living(The modified Rankin Scale 0-2) 2. At least one month since the most recent hemorrhagic stroke 3. The neurological deficit must be stable for more than 6 weeks 4. Bleeding in ventricle,cortex,basal ganglia,thalamus and subarachnoid space confirmed by computed tomography plain scan 5. 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 6. 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 7. Digital substraction angiography demonstrating the vasculopathy appeared unilaterally or bilaterally 8. Competent to give informed consent 9. Accessible and reliable for follow-up Exclusion Criteria: 1. Other cerebrovascular diseases(such as intracranial aneurysm or brain arteriovenous malformation) probably causing intracranial hemorrhage 2. Not independent in activity of daily living(The modified Rankin Scale 3-5) 3. Moyamoya syndrome concomitant with other hereditary or autoimmune diseases(Grave's Disease,Type I Diabetes Mellitus,Type I Neurofibromatosis et al) 4. Moyamoya disease with ruptured aneurysms located in the main stem of Willis' Circle 5. Emergent evacuation of intracerebral hematoma damaging superficial temporal artery or cortical artery 6. Emergent decompressive craniotomy causing automatically developed indirect revascularization 7. Good collateral networks formed by spontaneous anastomosis between extracranial and intracranial vessels before surgery 8. Life expectancy<1 years 9. Pregnancy 10. Unstable angina or myocardial infarction with recent 6 months 11. Blood coagulation dysfunction 12. Allergic to iodine contrast agent 13. Abnormal liver function(alanine transaminase(ALT) and/or aspartate aminotransferase(AST)>3 times of normal range) 14. Serum creatinine >3mg/dl 15. Poorly controlled hypertension(systolic BP>160 mmHg,diastolic BP>100 mmHg) 16. Poor glucose control(fasting blood glucose>16.7mmol/l) 17. Concurrent participation in any other interventional clinical trial

Additional Information

Official title The Adult Hemorrhagic Moyamoya Surgery Study
Description About one half of adult moyamoya patients present with hemorrhagic onset.As the bleeding events are potentially fatal, it often lead to particularly poor prognosis.However, the natural history is still poorly understood.Although the rebleeding rate is known to be extremely high,no effective therapeutic method has been established based on a worldwide consensus. The recently published Japanese Adult Moyamoya(JAM) Trial, which is the first prospective,randomized,controlled trial focused on hemorrhagic moyamoya,showed that direct bypass surgery could reduce the rebleeding rate and improve the prognosis.However,the result was statistically marginal with a small sample size and most importantly,it failed to assess the neurological function.The effect of bypass surgery on functional outcome was uncertain. Therefore,the AHMSS study in China is designed to compare the efficacy and safety of EC-IC bypass surgery with conservative treatment in adult moyamoya patients with hemorrhagic onset by comprehensive assessment of rebleeding rate, neurological function.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Huashan Hospital.