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