Angioplasty and Stenting versus medical treatment in patients with symptomatic intracranial artery stenosis: a randomized controlled trial and a preference cohort

INTERVENTION: Medical treatment will be given to all the participants. Basic drugs for the treatment are aspirin and clopidogrel. The aspirin and clopidogrel will be given orally at a dose of 100mg and 75mg per day respectively for 3 months. Patients in the PTAS group will receive the same dose of the aspirin and clopidogrel 5 days before operation, and continue for 3 months after the operation. When an emergency stenting operation is needed, a loading dose of 300 mg clopidogrel will be given. Additional medical treatment will be given to achieve a target systolic blood pressure of <140mmHg; hemoglobin A1c of <6.5% (in diabetes patients); low density lipoprotein of <2.58mmol/L. Interventions lowering the cardiovascular risk will also be used, such as lifestyle modification and smoking cessation. Participants who are allocated to PTAS will receive angioplasty and stenting within 5 days after randomization. A standard protocol of the PTAS procedure will be developed. The procedure will be performed by a cardiovascular surgeon. The participants will receive balloon‐angioplasty with a balloon catheter, followed by stenting using the Wingspan stent system (manufactured by Stryker Neurovascular). CONDITION: symptomatic intracranial artery stenosis PRIMARY OUTCOME: The primary outcome is a composite outcome, which is events of stroke or death assessed according to patient medical records. SECONDARY OUTCOME: The health‐related quality of life is assessed by the MOS 36‐item short‐form health survey (SF‐36). The incidence of recurrent ischaemic stroke in the territory of the stenosis arteries is assessed by CT or MRI images. The restenosis rate is assessed with the Magnetic Resonance Angiography (MRA) scan in the territory of the stenosis arteries. INCLUSION CRITERIA: 1. Patients aged from 18 to 70 years. 2. Complaints of a Symptomatic ICAS: a history of recurrent transient ischemic attacks or an ischemic stroke within 1 year owing to a stenosis from 70% to 99% in an internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery. 3. A length less than or equal to 15mm of a stenosis in the target vessel and a vessel size greater than or equal to 2mm. 4. Hypoperfusion in the territory of the target vessels, which is determined by CT or MRI in 14 days before stenting. 5. CT or MRI scans show no massive cerebral infarction (beyond half of the MCA territory), intracranial hemorrhage, epidural or sub‐dural hemorrhage, and intracranial brain tumor. 6. Patients who understand the purpose of the study and have provided informed consent.