NCT06899399|RecruitingDMC
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Sponsor study identifier
interventional
982
1 country
1
Study Start
October 18, 2024
Actual (reported)Primary Completion
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 18, 2024
Actual (reported)March 21, 2025
Actual (reported)March 28, 2025
Actual (reported)July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Within 30 days/ between 30 days and 12 months post-enrollment or post-procedure
Success rate of surgical technique
Surgery completed
Incidence of myocardial infarction
Within 30 days after surgery or within 30 days of enrollment
Incidence of ipsilateral stroke
Within 30 days after surgery or within 30 days of enrollment
Incidence of bilateral stroke
Within 30 days after surgery or within 30 days of enrollment
The incidence of all-cause death
Within 30 days after surgery or within 30 days of enrollment
Participants 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.
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
Feng Gao, MD
Beijing Tiantan Hospital
Zhongrong Miao, MD
Beijing Tiantan Hospital
First Submitted
March 21, 2025
First Posted
March 28, 2025
Study Start
October 18, 2024
Actual (reported)Primary Completion
July 2028
EstimatedParticipants 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.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 28, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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