Condition: Asymptomatic Carotid Artery Stenosis · Sponsor: Beijing Tiantan Hospital
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.
This description comes directly from the study's public registry record.
Dapeng Sun, MD · +8619520064886 · sundp1990@163.com
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| Beijing Tiantan Hospital, Capital Medical University | Beijing, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06899399