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

NCT06899399 | Recruiting DMC

• 1 other identifier: 2023ZD0505400
• Study Type: interventional
• Target: 982
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asymptomatic Carotid Artery Stenosis

Keywords

Asymptomatic carotid stenosis; Carotid stenting; Best medical therapy; Randomized controlled trial; Stroke prevention; Endovascular treatment; Carotid artery disease; Ischemic stroke

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• 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

Study Arms (2)

Internal carotid artery stenting and medical treatment

EXPERIMENTAL

Procedure: Endovascular treatment

Best Medical Therapy

ACTIVE COMPARATOR

Drug: Best medical treatment

Interventions

Endovascular treatment PROCEDURE

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.

Internal carotid artery stenting and medical treatment

Best medical treatment DRUG

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.

Best Medical Therapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• symptomatic internal carotid artery stenosis in the past 6 months
• Spontaneous intracranial hemorrhage in nearly one year
• Patients with larger intracranial aneurysms (diameter \>5 mm) who cannot undergo prior or concurrent treatment
• Chronic occlusion without obvious symptoms of cerebral ischemic attack
• Patients with transient or permanent neurological deficit resulting from Neurological deficits mimicking TIA/stroke from TIA or stroke
• Common carotid artery ostial lesion
• Tandem lesions with severe stenosis of the ipsilateral intracranial artery
• Patients with severe dementia
• Internal carotid artery dissection
• Internal carotid artery aneurysm
• Myocardial infarction within 30 days
• Ejection fraction \<30% or New York Heart Association (NYHA) functional class III or higher; unstable angina, characterized by angina at rest with electrocardiogram changes
• Cardiogenic embolism, including left ventricular aneurysm, intraluminal filling defects, cardiomyopathy, aortic or mitral valve-prosthetic heart valve, calcified aortic stenosis, infective endocarditis
• Mitral stenosis, atrial septal defect, atrial septal aneurysm or left chamber myxoma
• Two or more proximal or main coronary artery stenosis 70%, untreated or recanable

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carotid Artery Diseases; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke

Study Officials

• Feng Gao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Zhongrong Miao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dapeng Sun, MD

CONTACT

+8619520064886; sundp1990@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Interventional Neuroradiology, Department of Neurology

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: October 18, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)