Efficacy and Safety Study of Endovascular Treatment of Asymptomatic Carotid Artery Stenosis
Recruiting now · Not applicable
Conditions studied: Asymptomatic Carotid Artery Stenosis
In brief
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.
Key facts
- Study ID
- NCT06899399
- Run by
- Beijing Tiantan Hospital
- People needed
- 982
- Starts
- 2024-10-18
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2025-03-28
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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
- 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
- Malignant tumor or respiratory insufficiency, and a life expectancy of <5 years
- 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
- Contrast allergy
- Other general anesthesia operations are required during the same period
- Pregnant or lactating women
- The patient does not attend the clinical trial of other drug or medical device before enrollment
- The investigator is not considered fit to participate in this clinical study
- Imaging exclusion criteria:
Where it is running
- Beijing Tiantan Hospital, Capital Medical University — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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