A multicenter, open-label, blinded-endpoint, prospective, randomized controlled clinical trial with an "all comers" design.
The main objective of this study is to investigate the impact of angiography-derived fractional flow (Angio-FF) on diagnostic and therapeutic decision-making in patients with symptomatic intracranial atherosclerotic stenosis (sICAS). The study aims to evaluate whether stenting plus medical therapy, compared to medical therapy alone, can benefit patients selected through Angio-FF screening. For Group A, patients with significant stenosis and hemodynamic impairment identified through Angio-FF (≤0.7) screening are expected to have a higher risk. The patients will be enrolled in RCT trial, with a planned enrollment of 336 subjects. For Group B, patients with significant stenosis but without hemodynamic impairment identified through Angio-FF (\>0.7) screening will be included in the registry cohort, with a planned enrollment of 200 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
536
Patients randomized to intervention group received the percutaneous transluminal balloon angioplasty with stenting within 5 days after randomization, and loading dose of aspirin and clopidogrel was allowed. Received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after procedure.
Medical therapy alone: received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after randomisation.
Stroke or death
Stroke or death within 30 days after enrollment; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 30 days and 1 year.
Time frame: Stroke or death within 30 days after enrollment; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 30 days and 1 year.
Ischemic stroke in the target vessel territory
Ischemic stroke in the target vessel territory
Time frame: Within 1-3 years after enrollment
Ischemic stroke in non-target vessel territory
Ischemic stroke in non-target vessel territory
Time frame: Within 30 days to 1 year, and within 1-3 years after enrollment
Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
Time frame: Within 30 days to 3 years after enrollment
Any cause of death
Any cause of death
Time frame: Within 30 days to 3 years after enrollment
mRS score
Modified Rankin scale (mRS) score. The value range 0-6: higher scores mean a worse outcome.
Time frame: At 1 year, 2 years, and 3 years after enrollment
National Institutes of Health Stroke Scale (NIHSS) score
Stroke severity (NIHSS score). The value range 0-42: higher scores mean a worse outcome.
Time frame: At 1 year, 2 years, and 3 years after enrollment
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Barthel Index
An ordinal scale which measures a person's ability to complete activities of daily living. The value range 0-100: higher scores mean a better outcome.
Time frame: At 1 year, 2 years, and 3 years after enrollment