Tests a stent in the neck artery plus medicine in people without symptoms
Tests a neck artery stent with medicine in adults with severe narrowing.
Key facts
- Who runs it
- Beijing Tiantan Hospital
- Where
- Beijing, ChinaSee the site
- Trial code
- Registry title
- Efficacy and Safety Study of Endovascular Treatment of Asymptomatic Carotid Artery Stenosis
- Status
- Recruiting
- People taking part
- 982 people, planned
- Started
- 18 Oct 2024
- Expected to end
- Jul 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Endovascular treatment
- Best medical treatment
- Record updated
- 28 March 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40-80 with severe narrowing (70-99%) of one internal carotid artery who have had no related stroke symptoms in the past six months and declined surgery (carotid endarterectomy).
- Age
- 40 to 80 years
- Sex
- Men and women
- Disease stage
- Severe narrowing (70-99%) of the internal carotid artery without symptoms, confirmed by ultrasound, CTA or DSA. The artery on the other side is narrowed less than 70%.
- Earlier treatment
- Must have declined carotid endarterectomy. Must not have taken part in another drug or device trial before joining.
Main reasons for not taking part
- Stroke or TIA symptoms from the narrowed artery in the past 6 months
- Bleeding inside the skull in the past year
- Heart attack within 30 days, or severe heart failure
- Severe dementia
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 36 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients with larger intracranial aneurysms (diameter >5 mm) who cannot undergo prior or concurrent treatment
- The patient does not attend the clinical trial of other drug or medical device before enrollment
- Spontaneous intracranial hemorrhage in nearly one year
- Patients with transient or permanent neurological deficit resulting from Neurological deficits mimicking TIA/stroke from TIA or stroke
- Patients with severe dementia
- Myocardial infarction within 30 days
- Cardiogenic embolism, including left ventricular aneurysm, intraluminal filling defects, cardiomyopathy, aortic or mitral valve-prosthetic heart valve, calcified aortic stenosis, infective endocarditis
- Contrast allergy
- Ejection fraction <30% or New York Heart Association (NYHA) functional class III or higher; unstable angina, characterized by angina at rest with electrocardiogram changes
- Platelets <5 * 104 / uL, INR> 1.5, bleeding time> 1min or heparin-related thrombocytopenia; heparin is a contraindication to antiplatelet drugs; coagulopathy
- Poor controlled diabetes mellitus, fasting blood glucose> 22 mmol/L and ketone body>+2
- Severe liver and kidney function impairment, ALT> 3 times the upper limit of normal value or AST> 3 times the upper limit of normal value, blood creatinine increase> 2 times the upper limit of normal value
- Malignant tumor or respiratory insufficiency, and a life expectancy of <5 years
- The stenotic lesion exhibits severe circumferential calcification, defined as calcification greater than 3 mm in thickness visible in orthogonal views during fluoroscopy. (Note: In elderly subjects aged ≥70 years, anatomical factors such as tortuosity, arch anatomy, and calcification must be assessed more carefully)
- symptomatic internal carotid artery stenosis in the past 6 months
- Chronic occlusion without obvious symptoms of cerebral ischemic attack
- Common carotid artery ostial lesion
- Tandem lesions with severe stenosis of the ipsilateral intracranial artery
- Internal carotid artery dissection
- Internal carotid artery aneurysm
- 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
- Other general anesthesia operations are required during the same period
- Pregnant or lactating women
- The investigator is not considered fit to participate in this clinical study; Imaging exclusion criteria:
- Type III aortic arch
- Severe angulation or tortuosity (≥90 degrees) of the common carotid artery or innominate artery that prevents safe and rapid placement of a guiding catheter or long sheath
- Severe angulation or tortuosity of the internal carotid artery that prevents safe deployment of an embolic protection device or stent. Severe tortuosity is defined as the presence of two or more angles ≥90 degrees within 4 cm of the stenotic lesion
- Stenosis of the beginning or proximal end of the common carotid artery, innominate artery, distal or intracranial segment of the internal carotid artery, and the stenosis degree is greater than that of the target stenosis
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Where in China
- Beijing Tiantan Hospital,Capital Medical UniversityBeijing, ChinaContact: Dapeng Sun, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Internal carotid artery stenting and medical treatmentTreatment being tested
Treatment: Endovascular treatment
- Best Medical TherapyExisting treatment, for comparison
Treatment: Best medical treatment
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy and Safety Study of Endovascular Treatment of Asymptomatic Carotid Artery Stenosis
- Plain-language title
- Tests a stent in the neck artery plus medicine in people without symptomsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06899399, who can take part
- Record updated
- 28 March 2025