Clinical Trial

Efficacy and Safety Study of Endovascular Treatment of Asymptomatic Carotid Artery Stenosis

Recruiting
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Summary
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.
Trial Details
NCT Number NCT06899399
Lead Sponsor Beijing Tiantan Hospital
Conditions Asymptomatic Carotid Artery Stenosis
Enrollment 982 participants
Start Date 2024-10-18
Primary Completion 2028-07 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2025-03-28