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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

• Declined carotid endarterectomy

• Willing to complete 12-month follow-up

• Signed informed consent by participant/legal representative

Locations
Other Locations
China
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Dapeng Sun, MD
sundp1990@163.com
+8619520064886
Time Frame
Start Date: 2024-10-18
Estimated Completion Date: 2028-07
Participants
Target number of participants: 982
Treatments
Experimental: Internal carotid artery stenting and medical treatment
Active_comparator: Best Medical Therapy
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov

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