This prospective, multicenter, randomized controlled study enrolled patients undergoing carotid artery stenting (CAS) with cerebral embolic protection for carotid artery stenosis. They were randomly assigned to either a combination of proximal balloon occlusion, filter protection, intermediate catheter or filter protection alone. The study included 132 patients, and the primary endpoint was the number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure.
Carotid artery stenting (CAS) is an established treatment for carotid stenosis, yet the optimal cerebral embolic protection strategy remains uncertain. This prospective, multicenter, randomized, open-label, controlled trial will enroll 132 patients with symptomatic (≥50%) or asymptomatic (≥70%) carotid stenosis, who will be randomly assigned 1:1 to either experimental multimodal protection (Balloon Guide Catheter plus distal filter and intermediate catheter aspiration) or conventional distal filter protection alone. The primary endpoint is the number of new infarcts on post-procedural diffusion-weighted imaging (DWI) assessed within 48 hours (±24 hours), with secondary endpoints including device success and defect rates, incidences of symptomatic and all intracranial hemorrhage within 48 hours post-procedure, ipsilateral target-vessel stroke, TIA, major adverse events (stroke/death/MI), and adverse/serious adverse events at 30 and 90 days, all-cause mortality at 90 days, changes in mRS score at 30 and 90 days, and procedure-related complications (e.g., dissection, hyperperfusion syndrome).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
132
Balloon guide catheter for proximal flow arrest and debris aspiration during carotid stenting.
Distal embolic filter deployed beyond the stenosis to capture debris during stent placement.
Number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure
Total number of new DWI positive lesions on post procedural brain MRI within 48 hours (±24 hours). New lesions are defined as foci of hyperintensity not seen on baseline DWI (if available), or otherwise as lesions consistent with acute embolic infarction.
Time frame: within 48 hours (±24 hours) post-procedure
Device Success Rate
Device success for the balloon dilation catheter is defined as successful delivery, complete inflation, and smooth retrieval of the catheter system.
Time frame: during the procedure
Incidence of Major Adverse Events (MAE) within 30 days, including any stroke, death, and myocardial infarction.
The rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke, or myocardial infarction within 30-day post-procedure.
Time frame: within 30-day post-procedure
Changes in mRS score at 30 days and 90 days post-procedure.
Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death).
Time frame: 30 days and 90 days post-procedure
Incidence of ipsilateral target vessel stroke at 30 days and 90 days post-procedure.
Stroke is defined as an acute neurological deficit of vascular origin lasting ≥24 hours, or lasting \<24 hours with neuroimaging evidence of new infarction, occurring in the territory of the treated carotid artery.
Time frame: 30 days and 90 days post-procedure
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Incidence of transient ischemic attacks (TIA) at 30 days and 90 days post-procedure.
Transient ischemic attacks (TIA) was defined as transient focal neurological deficit of vascular origin lasting \<24 hours with no acute infarct on neuroimaging.
Time frame: 30 days and 90 days post-procedure
Incidence of Procedure-related complications (e.g., vessel dissection, hyperperfusion syndrome, etc.).
Procedure related complications include vessel dissection, hyperperfusion syndrome, access site events, and other adverse events directly attributable to carotid artery stenting (CAS).
Time frame: during the procedure
Incidence of adverse events and serious adverse events at 30 days and 90 days post-procedure.
The Incidence of Adverse events or severe adverse event at 30 days and 90 days post-procedure.
Time frame: 30 days and 90 days post-procedure
Incidence of symptomatic intracranial hemorrhage within 48 hours (±24 hours) post-procedure.
Symptomatic intracranial hemorrhage defined as any intracranial hemorrhage on imaging with new neurological symptoms or NIHSS increase ≥4, or death.
Time frame: within 48 hours (±24 hours) post-procedure
Incidence of intracranial hemorrhage within 48 hours (±24 hours) post-procedure.
Incidence of all intracranial hemorrhage on post-procedural brain imaging within 48 hours.
Time frame: within 48 hours (±24 hours) post-procedure
Incidence of all-cause mortality within 90 days post-procedure.
Incidence of death from any cause occurring within 90 days following the procedure.
Time frame: 90 days post-procedure
Incidence of device defects.
The Incidence of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc.
Time frame: during the procedure