This multicenter, randomized, controlled trial evaluates a combined embolic protection strategy during carotid artery stenting (CAS). Carotid artery stenosis is a major cause of stroke. While stenting is an effective treatment, the procedure itself carries a risk of dislodging plaque debris, which can travel to the brain and cause new strokes or silent brain infarctions. Currently, a distal filter (protection device) is standardly used to catch debris. However, it may not capture all particles. This study investigates whether adding a Balloon Guide Catheter (BGC)-which temporarily stops blood flow and allows for aspiration-to the standard filter protection is more effective than using the filter alone. Patients with symptomatic (≥50% stenosis) or asymptomatic (≥70% stenosis) carotid artery stenosis who are scheduled for stenting will be randomly assigned to one of two groups: 1. Combined Protection Group: Receiving CAS using a Balloon Guide Catheter combined with a distal filter. 2. Standard Protection Group: Receiving CAS using a distal filter alone. The primary goal is to determine if the combined approach reduces the number of new ischemic lesions detected on brain MRI within 72 hours post-procedure. The study will also assess clinical stroke events over a 90-day follow-up period.
Pre-specified subgroup analyses will be conducted based on baseline symptom status (symptomatic vs. asymptomatic carotid artery stenosis) and stent design (open-cell vs. closed-cell).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
296
A catheter with a balloon at the distal tip, used to temporarily arrest flow and aspirate debris during the stenting procedure.
A mesh-type device deployed distally to the stenosis to capture embolic debris during the procedure.
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGNumber of New Ischemic Lesions on Diffusion-Weighted Imaging (DWI)
Assessed by brain MRI (DWI sequences) performed within 72 hours post-procedure. The outcome is defined as the total number of new high-signal intensity lesions observed on the post-procedural DWI compared to pre-procedural baseline (if available) or recognized as new procedural emboli.
Time frame: Post-procedure 72 hours (plus or minus 12 hours)
Procedural Success Rate
Defined as the successful deployment and retrieval of the stent and protection devices (Balloon Guide Catheter and/or Distal Filter) without technical failure.
Time frame: Intra-operative
Total Volume of New Ischemic Lesions on DWI
The total volume (in milliliters) of new ischemic lesions measured on DWI MRI.
Time frame: Post-procedure 72 hours (± 12 hours)
Incidence of New Symptomatic Ischemic Stroke
Occurrence of a new ischemic stroke presenting with clinical symptoms.
Time frame: Post-procedure 72 hours (± 12 hours)
Rate of Early Neurological Deterioration (NIHSS Worsening)
Defined as an increase in the National Institutes of Health Stroke Scale (NIHSS) score of \> 2 points compared to baseline.
Time frame: Post-procedure 72 hours (± 12 hours)
All-Cause Mortality at 30 Days
Time frame: 30 days (± 5 days)
Rate of Excellent Functional Outcome (mRS 0-1) at 30 Days
Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 1
Time frame: 30 days (± 5 days)
Rate of Functional Independence (mRS 0-2) at 30 Days
Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 2.
Time frame: 30 days (± 5 days)
Quality of Life Assessment using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at 30 Days
The EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels. The responses are converted into a single utility index score (ranging from less than 0 to 1, where 1 indicates full health and 0 indicates dead). Higher scores indicate better health-related quality of life.
Time frame: 30 days (± 5 days)
Rate of Excellent Functional Outcome (mRS 0-1) at 90 Days
Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 1.
Time frame: 90 days (± 7 days)
Rate of Functional Independence (mRS 0-2) at 90 Days
Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 2.
Time frame: 90 days (± 7 days)
Quality of Life Assessment using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at 90 Days
The EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels. The responses are converted into a single utility index score (ranging from less than 0 to 1, where 1 indicates full health and 0 indicates dead). Higher scores indicate better health-related quality of life.
Time frame: 90 days (± 7 days)
Incidence of Symptomatic Intracranial Hemorrhage
Time frame: Post-procedure 72 hours (± 12 hours)
Incidence of Any Intracranial Hemorrhage
Time frame: Post-procedure 72 hours (± 12 hours)
Incidence of Adverse Events (AEs)
Number of participants with adverse events.
Time frame: Through study completion, up to 90 days
Incidence of Serious Adverse Events (SAEs)
Number of participants with serious adverse events.
Time frame: Through study completion, up to 90 days
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