Carotid angioplasty and stenting (CAS) is an effective treatment for carotid artery stenosis but carries a risk of cerebral embolization. This prospective randomized study evaluates the safety and efficacy of proximal embolic protection using a balloon guide catheter during CAS by comparing the incidence of diffusion-weighted MRI-detected microembolisms and symptomatic thromboembolic events between protected and unprotected procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
126
Carotid artery stenting with proximal embolic protection using a balloon guide catheter.
Carotid artery stenting without proximal embolic protection
Incidence, number, and volume of new cerebral ischemic lesions detected by diffusion-weighted MRI within 48 hours after carotid artery stenting
Time frame: Within 48 hours after the procedure
Incidence of symptomatic thromboembolic events (stroke or transient ischemic attack) within 30 days
Time frame: During the procedure and within 30 days after the intervention
Incidence of myocardial infarction or death within 30 days
Time frame: 30days
Technical success of carotid artery stenting procedure
Technical success defined as successful deployment of the stent with residual stenosis \<30% and restoration of adequate blood flow without the need for conversion to another technique.
Time frame: 30days
Correlation between DW-MRI findings and clinical outcomes
Time frame: 30 days
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