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
Qualifiers
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
Treatments tested in this trial
- balloon guide catheter
- No Proximal Protection Group