NCT06899399

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 982 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This multicenter, prospective, open-label, randomized controlled trial with blinded endpoint assessment aims to evaluate the safety and efficacy of endovascular stenting combined with best medical therapy (BMT) versus BMT alone in patients with asymptomatic severe stenosis (70-99%) of the internal carotid artery (ICA). The study will enroll 982 participants aged 40-80 years who have no history of ipsilateral transient ischemic attack (TIA), stroke, or related neurological symptoms within the past 6 months and have declined carotid endarterectomy. The primary objective is to determine whether stenting reduces the composite risk of stroke, myocardial infarction, or death within 30 days post-procedure/enrollment, as well as ipsilateral stroke from 30 days to 1 year. Secondary objectives include assessing procedural success, restenosis rates, cognitive outcomes (measured by Montreal Cognitive Assessment \[MoCA\] and Mini-Mental State Examination \[MMSE\]), and long-term clinical outcomes. The trial will be conducted across multiple centers in China, led by Beijing Tiantan Hospital, Capital Medical University. Participants will be randomly assigned (1:1) via a computer-generated stratified randomization scheme to either the intervention group (endovascular stenting plus BMT) or the control group (BMT alone). BMT includes antiplatelet therapy, lipid-lowering agents, blood pressure control, and management of other cardiocerebrovascular risk factors. Endpoint adjudication will be performed by an independent blinded clinical events committee to minimize bias. Eligible participants must have severe ICA origin stenosis confirmed by ultrasound, computed tomography angiography (CTA), or digital subtraction angiography (DSA), with contralateral ICA stenosis \<70%. Key exclusion criteria include recent symptomatic stenosis, intracranial hemorrhage within 1 year, severe cardiopulmonary comorbidities, contraindications to antiplatelet/anticoagulant therapy, life expectancy \<5 years, or anatomical challenges (e.g., Type III aortic arch, severe vascular tortuosity/calcification). Imaging exclusions focus on technical feasibility and safety, such as tandem intracranial stenosis or distal lesions more severe than the target stenosis. The primary endpoints are the 30-day composite rate of stroke, myocardial infarction, or death, and the incidence of ipsilateral stroke between 30 days and 1 year. Secondary endpoints include technical success (defined as residual stenosis \<30% with Thrombolysis in Myocardial Infarction \[TIMI\] grade 3 flow post-procedure), 30-day and 12-month mortality, restenosis rates, and cognitive changes. Statistical analysis will follow the intention-to-treat principle, with Kaplan-Meier survival analysis and log-rank tests for primary outcomes. Cox proportional hazards models will estimate hazard ratios (HRs) with 95% confidence intervals (CIs). Sensitivity analyses will use per-protocol and as-treated populations. The study duration is scheduled from August 2024 to July 2028, including a 12-month follow-up period. Ethical approval will be obtained from all participating centers, and the trial will adhere to the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines.

Conditions

• Asymptomatic Carotid Artery Stenosis

Interventions

Type	Name	Description
PROCEDURE	Endovascular treatment	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.
DRUG	Best medical treatment	Participants 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.

Timeline

• Start date: 2024-10-18
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-03-28
• Last updated: 2025-03-28

Locations

1 site across 1 country: China