Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on prevention of events of stroke and death in patients with symptomatic intracranial atherosclerosis (ICAS) is controversial. Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in preventing events of stroke and death in patients with symptomatic ICAS. Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily) immediately after randomization, and patients in PTAS+MT group will receive surgery within 5 days after randomization. The patients will be followed up for 1 year after randomization and assessed for events of stroke and death at 30 days and 1 year after randomization, the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30 days and 1 year after randomization, incidence of in-stent restenosis at 1 year after randomization,etc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
394
Surgeons will plant stents after vascular angioplasty in target ICAS vessels within 5 days after randomization.
aspirin 100mg daily and clopidogrel 75mg daily for 90 days
Proportion of patients with events of stroke or death
Time frame: at 30 days after randomization
the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory
Time frame: 30 days and 1 year after randomization
neurological functional outcome by the Chinese version of National Institutes of Health Stroke Scale (C-NIHSS)
Time frame: 30 days and 1 year after randomization
Proportion of patients with adverse events
Time frame: 30 days and 1 year after randomization
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