A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial that aims to evaluate the effect of immediate angioplasty (with or without stenting) for acute ischemic stroke (AIS) with severe intracranial atherosclerotic stenosis (ICAS) in improving the 90-day functional outcome.
Aged 18 years or older.
Diagnosed with AIS and baseline NIHSS ≥6.
Pre-stroke mRS ≤2.
Time from symptom onset to randomization ≤ 24 hours; the onset time refers to "Last Known Well" (LKW).
Normal diameter of the culprit vessel <2.0 mm.
Isolated perforator artery infarction (except for combined cortical hypoperfusion).
Hemorrhagic stroke within the past 90 days.
Cerebrovascular conditions such as vasculitis, moya-moya disease, arterial inflammatory stenosis, vasospasm, traumatic dissection, etc..
Parallel
Immediate angioplasty
Procedure/SurgerySee arm/group descriptions.
The modified Rankin Scale (mRS) 0-2
The proportion of the mRS 0-2 at 90 days.
The mRS 0-1
The proportion of the mRS of 0-1 at 90 days.
The mRS 0-3
The proportion of the mRS of 0-3 at 90 days.
The shift analysis of the mRS distribution
The distribution of the mRS at 90 days.
The change of National Institute of Health Stroke Scale (NIHSS)
The change of NIHSS from baseline to 7 days or discharge (whichever comes first).
SAFETY OUTCOME: Symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage within 36 hours (according to Heidelberg criteria).
SAFETY OUTCOME: Mortality
Mortality at 90 days.
SAFETY OUTCOME: Any intracranial hemorrhage
Any intracranial hemorrhage within 36 hours (according to Heidelberg criteria).
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor
Shenzhen Hospital of Southern Medical University
Collaborator
