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.
- Extracranial-intracranial bypass surgery Procedure
Other Names: STA-MCA Bypass and EDMS Intervention Desc: 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) ARM 1: Kind: Experimental Label: Surgical intervention Description: All participants in this group will be assigned to receive extracranial-intracranial arterial bypass surgery.
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||All strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards||within 5 years of randomization||No|
|Secondary||All kinds of adverse events related to surgery||up to 30 days||Yes|
|Secondary||Rebleeding on the contralateral side||up to 5 years||No|
|Secondary||Transient ischemic attack on the surgically treated side||up to 5 years||No|
|Secondary||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||No|
|Secondary||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||No|
|Secondary||The changes from baseline in modified Barthel Index||at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial||No|
- Huashan Hospital Lead