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.
This study is a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the effect of immediate angioplasty (with or without stenting) for AIS with severe ICAS. The primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-2. Study intervention: (1) Participants in the intervention group will undergo immediate angioplasty (with or without stenting), and will receive the best medical treatment (BMT) after the procedure. (2) Participants in the control group will receive BMT alone. This study is anticipated to enroll 412 participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
412
See arm/group descriptions.
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGShenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China
RECRUITINGThe modified Rankin Scale (mRS) 0-2
The proportion of the mRS 0-2 at 90 days.
Time frame: 90(±7) days
The mRS 0-1
The proportion of the mRS of 0-1 at 90 days.
Time frame: 90(±7) days
The mRS 0-3
The proportion of the mRS of 0-3 at 90 days.
Time frame: 90(±7) days
The shift analysis of the mRS distribution
The distribution of the mRS at 90 days.
Time frame: 90(±7) 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).
Time frame: 7(±1) days or discharge, whichever came first
Any new stroke (ischemic/hemorrhagic) or all-cause mortality
Any new stroke (ischemic/hemorrhagic) or all-cause mortality within 30 days
Time frame: within 30 days
Any recurrent stroke in the territory of the target artery
Any recurrent stroke in the territory of the target artery within 90 days
Time frame: within 90 days
The quality of life
The value of quality of life (EQ-5D-5L) at 90 days.
Time frame: 90(±7) days
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