Evaluating endovascular treatment for asymptomatic carotid artery stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, open-label, randomized controlled trial aims to assess the safety and efficacy of endovascular stenting combined with optimal medical therapy versus optimal medical therapy alone in patients with severe asymptomatic carotid artery stenosis. The study will enroll 982 participants aged 40-80 years who have not experienced any neurological symptoms related to the carotid artery in the past six months and have declined carotid endarterectomy. Primary endpoints include the incidence of stroke, myocardial infarction, or death within 30 days post-procedure, as well as ipsilateral stroke occurrences from 30 days to one year. Secondary endpoints will evaluate procedural success, restenosis rates, and cognitive function changes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 40-80 years
2. Severe asymptomatic internal carotid artery stenosis (70-99%) confirmed by ultrasound/CTA/DSA
3. Contralateral ICA stenosis \<70%
4. No TIA/stroke related to target lesion in past 6 months
5. Declined carotid endarterectomy
6. Willing to complete 12-month follow-up
7. Signed informed consent by participant/legal representative

Exclusion Criteria:

1. symptomatic internal carotid artery stenosis in the past 6 months
2. Spontaneous intracranial hemorrhage in nearly one year
3. Patients with larger intracranial aneurysms (diameter \>5 mm) who cannot undergo prior or concurrent treatment
4. Chronic occlusion without obvious symptoms of cerebral ischemic attack
5. Patients with transient or permanent neurological deficit resulting from Neurological deficits mimicking TIA/stroke from TIA or stroke
6. Common carotid artery ostial lesion
7. Tandem lesions with severe stenosis of the ipsilateral intracranial artery
8. Patients with severe dementia
9. Internal carotid artery dissection
10. Internal carotid artery aneurysm
11. Myocardial infarction within 30 days
12. Ejection fraction \<30% or New York Heart Association (NYHA) functional class III or higher; unstable angina, characterized by angina at rest with electrocardiogram changes
13. Cardiogenic embolism, including left ventricular aneurysm, intraluminal filling defects, cardiomyopathy, aortic or mitral valve-prosthetic heart valve, calcified aortic stenosis, infective endocarditis
14. Mitral stenosis, atrial septal defect, atrial septal aneurysm or left chamber myxoma
15. Two or more proximal or main coronary artery stenosis 70%, untreated or recanable
16. Platelets \<5 \* 104 / uL, INR\> 1.5, bleeding time\> 1min or heparin-related thrombocytopenia; heparin is a contraindication to antiplatelet drugs; coagulopathy
17. Poor controlled diabetes mellitus, fasting blood glucose\> 22 mmol/L and ketone body\>+2
18. Malignant tumor or respiratory insufficiency, and a life expectancy of \<5 years
19. 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
20. Contrast allergy
21. Other general anesthesia operations are required during the same period
22. Pregnant or lactating women
23. The patient does not attend the clinical trial of other drug or medical device before enrollment
24. The investigator is not considered fit to participate in this clinical study

Imaging exclusion criteria:

1. Type III aortic arch
2. 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
3. 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
4. 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
5. 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)

Where it's running

• Beijing Tiantan Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Principal investigator: Feng Gao, MD — Beijing Tiantan Hospital
• Study coordinator: Dapeng Sun, MD
• Email: sundp1990@163.com
• Phone: +8619520064886

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.