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

Launched by BEIJING TIANTAN HOSPITAL · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for patients with severe narrowing of the carotid artery, called asymptomatic carotid artery stenosis, which means they have significant blockage but no recent symptoms like stroke or mini-strokes. The trial aims to compare two approaches: one group will receive a procedure called endovascular stenting along with standard medical treatment, while the other group will receive only the standard medical treatment. The goal is to see which approach is safer and more effective in preventing serious issues like stroke or heart attack within a year.

To participate in this trial, patients must be between 40 and 80 years old, have a certain level of artery narrowing confirmed by imaging tests, and have not experienced any related neurological symptoms in the past six months. They also need to be willing to complete follow-up appointments for a year. If chosen for the trial, participants can expect close monitoring of their health, and they will be part of a study that could help improve treatment options for others in the future.

Gender

ALL

Eligibility criteria

• 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)