This study is a multicenter, prospective, open-label, endpoint-blinded, randomized controlled trial designed to evaluate the safety and efficacy of endovascular stenting combined with optimal medical therapy versus optimal medical therapy alone in patients with asymptomatic severe stenosis (70-99%) of the internal carotid artery. The study plans to enroll 982 patients aged 40-80 years who have had no ipsilateral carotid artery-related neurological symptoms in the past six months and who have declined carotid endarterectomy. The primary endpoints include stroke, myocardial infarction, or death within 30 days post-procedure/enrollment, as well as the incidence of ipsilateral stroke from 30 days to one year post-procedure/enrollment. Secondary endpoints include procedural success rate, restenosis rate, changes in cognitive function, and others. The study results will provide high-level evidence-based medical evidence for the treatment selection of patients with asymptomatic carotid artery stenosis.
Age 40-80 years
Severe asymptomatic internal carotid artery stenosis (70-99%) confirmed by ultrasound/CTA/DSA
Contralateral ICA stenosis <70%
No TIA/stroke related to target lesion in past 6 months
symptomatic internal carotid artery stenosis in the past 6 months
Spontaneous intracranial hemorrhage in nearly one year
Patients with larger intracranial aneurysms (diameter >5 mm) who cannot undergo prior or concurrent treatment
Chronic occlusion without obvious symptoms of cerebral ischemic attack
Parallel
Endovascular treatment
Procedure/SurgeryParticipants will receive carotid artery stenting as the primary intervention. The procedure will be performed via femoral artery access (radial access allowed for anatomically challenging cases) with mandatory use of an embolic protection device (EPD). Stent selection and EPD type will be determined by the operator based on lesion characteristics. Pre-procedural dual antiplatelet therapy (DAPT: aspirin 100 mg/day + clopidogrel 75 mg/day) will be administered for ≥3-5 days. Post-procedural DAPT will continue for 3 months, transitioning to aspirin monotherapy (100 mg/day) thereafter. Statins and risk factor management (blood pressure、LDL-C, glycemic control) will align with standardized protocols.
Best medical treatment
DrugParticipants will receive intensive medical management, including aspirin (75-325 mg/day) or alternative antiplatelet agents (clopidogrel/dipyridamole) for intolerance. Statin therapy and risk factor control targets (blood pressure, lipids, glucose, lifestyle) will mirror the experimental group. Both groups will undergo regular follow-up for adherence monitoring.
Efficacy endpoint
The primary outcome was a composite of any stroke, myocardial infarction (MI), or all-cause mortality within 30 days post-enrollment or post-procedure, plus ipsilateral stroke between 30 days and 12 months post-enrollment/procedure.
Success rate of surgical technique
Success rate of surgical technique (defined as final residual stenosis \<30%,TIMI grade 3, no dissection or thrombosis after endovascular treatment)
Incidence of myocardial infarction
Incidence of myocardial infarction within 30 days after surgery or within 30 days of enrollment
Incidence of ipsilateral stroke
Incidence of ipsilateral stroke within 30 days after surgery or within 30 days of enrollment
Incidence of bilateral stroke
Incidence of bilateral stroke within 30 days after surgery or within 30 days of enrollment
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