About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Symptomatic or asymptomatic carotid artery stenosis
Candidate for carotid artery stenting
Written informed consent provided
Disqualifiers
Vascular anatomy unsuitable for balloon guide catheter placement
Severe renal failure
Previous disabling stroke or symptomatic intracranial hemorrhage
Evidence of carotid thrombus
Trial design
Parallel
Treatments tested in this trial
balloon guide catheter
DeviceCarotid artery stenting with proximal embolic protection using a balloon guide catheter.
No Proximal Protection Group
Other interventionCarotid artery stenting without proximal embolic protection
Treatment groups
Trial outcomes
Primary outcomes
Incidence, number, and volume of new cerebral ischemic lesions detected by diffusion-weighted MRI within 48 hours after carotid artery stenting
Secondary outcomes
Incidence of symptomatic thromboembolic events (stroke or transient ischemic attack) within 30 days
Incidence of myocardial infarction or death within 30 days
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.
Correlation between DW-MRI findings and clinical outcomes
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: