A multicenter, open-label, blinded-endpoint, prospective, randomized controlled clinical trial with an "all comers" design.
Age ≥30 and ≤80 years old.
Symptomatic intracranial atherosclerotic stenosis: Transient ischemic attack (TIA) or stroke related to 70%-99% stenosis in the major intracranial arteries (intracranial segment of the internal carotid artery, M1 segment of the middle cerebral artery, V4 segment of the vertebral artery, and basilar artery) within the past 3 months.
Only one target vessel with 70-99% stenosis confirmed by angiography for enrollment in the trial (WASID criteria).
Patients with ischemic stroke should be performed with stenting beyond a duration of 2 weeks from the latest ischemic symptom onset, patients with TIA have no time restriction.
Intracranial arterial stenosis not caused by atherosclerotic lesions, such as arterial dissection, moya-moya disease, vasculitic disease, viral vascular lesions (e.g., herpes zoster, varicella), neurosyphilis, other intracranial infections, radiation-induced vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, benign central nervous system vascular diseases, postpartum angiopathy, suspected vasospastic process, suspected recanalized embolus, etc.
Any conditions that precludes proper angiographic assessment.
Preoperative MRI indicating only lacunar infarction in the target lesion territory.
History of subarachnoid hemorrhage, subdural or epidural hematoma within 30 days prior to enrollment, or untreated chronic subdural hematoma thickness≥5mm, or history of primary intracerebral hemorrhage.
Parallel
Stenting plus medical therapy
Combination productPatients 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
DrugMedical 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.
Ischemic stroke in the target vessel territory
Ischemic stroke in the target vessel territory
Ischemic stroke in non-target vessel territory
Ischemic stroke in non-target vessel territory
Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
Any cause of death
Any cause of death
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