Actively Recruiting
Efficacy and Safety Study of Endovascular Treatment of Asymptomatic Carotid Artery Stenosis
Led by Beijing Tiantan Hospital · Updated on 2025-03-28
982
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining endovascular stenting with optimal medical therapy compared to medical therapy alone in patients with severe narrowing (70-99%) of the internal carotid artery who have no symptoms. This large, multicenter, randomized controlled trial plans to enroll 982 patients aged 40 to 80 years who have not experienced related neurological symptoms in the past six months and have declined surgery. The study aims to provide strong evidence to guide treatment choices for asymptomatic carotid artery stenosis. Participants will be randomly assigned to receive either endovascular stenting plus best medical therapy (including antiplatelet drugs, statins, and risk factor control) or best medical therapy alone. The stenting procedure involves accessing the artery through the femoral or radial artery and using an embolic protection device. Dual antiplatelet therapy is given before and after the procedure, followed by aspirin alone. Both groups will have regular follow-ups to monitor treatment adherence and outcomes. During the study, researchers will assess the occurrence of stroke, heart attack, or death within 30 days and up to one year after treatment or enrollment. Other evaluations include procedural success, artery narrowing recurrence, and changes in cognitive function measured by MoCA and MMSE tests. The study will last from 2024 to 2028, with a 12-month follow-up for each participant, and includes independent review of clinical events to ensure unbiased results.
CONDITIONS
Brief Title
Efficacy and Safety Study of Endovascular Treatment of Asymptomatic Carotid Artery Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 to 80 years
- Severe asymptomatic internal carotid artery stenosis (70-99%) confirmed by ultrasound, CTA, or DSA
- Contralateral internal carotid artery stenosis less than 70%
- No transient ischemic attack or stroke related to the target artery in the past 6 months
- Declined carotid endarterectomy surgery
- Willing to complete a 12-month follow-up
- Signed informed consent by participant or legal representative
You will not qualify if you...
- Symptomatic internal carotid artery stenosis in the past 6 months
- Intracranial hemorrhage within the past year
- Large intracranial aneurysms over 5 mm without prior or concurrent treatment
- Chronic artery occlusion without clear ischemic symptoms
- Neurological deficits mimicking transient ischemic attack or stroke
- Common carotid artery ostial lesion
- Severe stenosis of the ipsilateral intracranial artery (tandem lesions)
- Severe dementia
- Internal carotid artery dissection or aneurysm
- Myocardial infarction within 30 days
- Heart failure with ejection fraction less than 30% or NYHA class III or higher; unstable angina
- Cardiogenic embolism or significant heart valve disease
- Severe coronary artery stenosis untreated or not reachable
- Blood clotting disorders or contraindications to antiplatelet drugs
- Poorly controlled diabetes with very high blood sugar
- Malignant tumor or respiratory failure with life expectancy less than 5 years
- Severe liver or kidney impairment
- Allergy to contrast agents
- Need for other general anesthesia operations during the same period
- Pregnant or breastfeeding women
- Participation in other drug or device trials before enrollment
- Investigator decision deeming participant unfit
- Imaging exclusions including Type III aortic arch, severe vascular tortuosity or calcification preventing safe procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 5 days
Participants assigned to the stenting group receive pre-procedural dual antiplatelet therapy for at least 3 to 5 days before the procedure.
1 visit (in-person)
Duration - Procedure day plus 3 months of dual antiplatelet therapy followed by ongoing best medical therapy
Participants receive either carotid artery stenting combined with best medical therapy or best medical therapy alone to manage severe asymptomatic carotid artery stenosis.
1 procedure visit plus regular follow-up visits
Duration - Up to 12 months
Participants are monitored for safety, cognitive function, restenosis rates, and clinical outcomes for up to 12 months after enrollment or treatment.
Regular visits for up to 12 months
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
Actively Recruiting
Research Team
D
Dapeng Sun, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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