Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
NCT06899399

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

193 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 40 and 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, stroke, or neurological symptoms related to the target lesion in the past 6 months
  • Declined carotid endarterectomy surgery
  • Willing to complete 12-month follow-up
  • Signed informed consent by participant or legal representative
Not Eligible

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 (diameter over 5 mm) without prior or concurrent treatment
  • Chronic occlusion without symptoms of cerebral ischemic attack
  • Neurological deficits mimicking transient ischemic attack or stroke
  • Common carotid artery ostial lesion
  • Tandem lesions with severe stenosis of the ipsilateral intracranial artery
  • Severe dementia
  • Internal carotid artery dissection or aneurysm
  • Myocardial infarction within 30 days
  • Ejection fraction below 30% or severe heart failure (NYHA class III or higher)
  • Unstable angina with ECG changes
  • Cardiogenic embolism conditions (e.g., left ventricular aneurysm, cardiomyopathy, prosthetic heart valve, infective endocarditis)
  • Mitral stenosis, atrial septal defects, atrial septal aneurysm, or left chamber myxoma
  • Two or more proximal or main coronary artery stenoses over 70%, untreated or not recanalized
  • Platelet count below 5 x 10^4/uL, INR over 1.5, bleeding time over 1 minute, or heparin-related thrombocytopenia
  • Poorly controlled diabetes (fasting blood glucose over 22 mmol/L and ketone bodies positive +2)
  • Malignant tumor or respiratory insufficiency with life expectancy less than 5 years
  • Severe liver or kidney impairment (ALT or AST over 3 times upper limit, creatinine over 2 times upper limit)
  • Allergy to contrast agents
  • Other general anesthesia operations required during the same period
  • Pregnant or breastfeeding
  • Participation in other drug or medical device trials before enrollment
  • Investigator considers participant unfit for study
  • Imaging exclusions including Type III aortic arch, severe vessel tortuosity or angulation preventing safe catheter placement, stenosis in other arteries more severe than target lesion, and severe calcification thicker than 3 mm visible on fluoroscopy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

Actively Recruiting

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Research Team

D

Dapeng Sun, MD

CONTACT

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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