The Adult Hemorrhagic Moyamoya Surgery Study

Phase 3UnknownNCT02319980

Huashan Hospital360 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

360

Conditions

Moyamoya Stroke

Interventions

Extracranial-intracranial bypass surgeryPROCEDURE

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Neurosurgery,Huashan Hospital,Fudan University

Shanghai, China

Outcomes

Primary Outcomes

All strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards

The number of participants who suffer from all strokes \& death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards within 5 years of randomization

Time frame: within 5 years of randomization

Secondary Outcomes

All kinds of adverse events related to surgery

The number of participants who suffer from all kinds of adverse events related to surgery within 30 days

Time frame: up to 30 days

Rebleeding on the contralateral side

The number of participants who suffer from rebleeding on the contralateral side within 5 years of randomization

Time frame: up to 5 years

Transient ischemic attack on the surgically treated side

The number of participants who suffer from TIA on the surgically treated side within 5 years of randomization

Time frame: up to 5 years

The changes from baseline in modified Rankin Scale (mRS)

The changes from baseline in modified Rankin Scale (mRS) at 7 days, 30 days, 6 months, 12 months, 24 months，36 months，60 months or end of trial

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)

The changes from baseline in National Institute of Health Stroke Scale (NIHSS) at 7 days, 30 days, 6 months, 12 months, 24 months，36 months，60 months or end of trial

Time frame: at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial

Data from ClinicalTrials.gov

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