Carotid Artery Stenosis
Conditions
Keywords
Carotid artery stenosis, Carotid Artery Stenting, Balloon Guide Catheter, Embolic Protection Device, New Ischemic Lesions
Brief summary
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.
Detailed description
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).
Interventions
DEVICEBalloon Guide Catheter
A catheter with a balloon at the distal tip, used to temporarily arrest flow and aspirate debris during the stenting procedure.
DEVICEDistal Filter Protection Device
A mesh-type device deployed distally to the stenosis to capture embolic debris during the procedure.
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
： 1. Age 18 years or older; 2. Symptomatic extracranial carotid artery stenosis (occurrence of transient ischemic attack or non-disabling stroke in the ipsilateral carotid territory within the previous 6 months, with stenosis of 50% or greater) or asymptomatic extracranial carotid artery stenosis (stenosis of 70% or greater) meeting the indications for interventional treatment (stenosis degree measured by the NASCET method); 3. Pre-treatment modified Rankin Scale (mRS) score of 0 to 1; 4. Planned for stent treatment by the clinical care team; 5. Informed consent obtained from the patient or their legally authorized representative.
Exclusion criteria
： 1. Occlusion or severe stenosis (70% or greater) of the intracranial segment of the ipsilateral internal carotid artery system; 2. Occlusion or severe stenosis (70% or greater) of the contralateral common carotid artery or internal carotid artery; 3. History of stenting in the head and neck vessels within 3 months; 4. Coexisting other cerebrovascular diseases, such as intracranial aneurysms greater than 5 mm or cerebrovascular malformations; 5. Onset of stroke within 7 days; 6. Large old infarctions from previous stroke that may confound the evaluation of endpoints; 7. Contraindications to magnetic resonance imaging (MRI); 8. Definite risk of cardiogenic embolism (e.g., atrial fibrillation, atrial flutter, intracardiac thrombus) or clear indications for anticoagulation therapy; 9. Absolute or relative contraindications to antiplatelet therapy; 10. Pregnant or lactating women; 11. Allergy or hypersensitivity to contrast media or stent materials (e.g., Nitinol); 12. Life expectancy less than 1 year; 13. Pre-existing neurological or psychiatric disorders (e.g., severe dementia) that would confound neurological assessments; 14. Severe renal insufficiency (eGFR less than 30 mL/min).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of New Ischemic Lesions on Diffusion-Weighted Imaging (DWI) | Post-procedure 72 hours (plus or minus 12 hours) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success Rate | Intra-operative | Defined as the successful deployment and retrieval of the stent and protection devices (Balloon Guide Catheter and/or Distal Filter) without technical failure. |
| Total Volume of New Ischemic Lesions on DWI | Post-procedure 72 hours (± 12 hours) | The total volume (in milliliters) of new ischemic lesions measured on DWI MRI. |
| Incidence of New Symptomatic Ischemic Stroke | Post-procedure 72 hours (± 12 hours) | Occurrence of a new ischemic stroke presenting with clinical symptoms. |
| Rate of Early Neurological Deterioration (NIHSS Worsening) | Post-procedure 72 hours (± 12 hours) | Defined as an increase in the National Institutes of Health Stroke Scale (NIHSS) score of \> 2 points compared to baseline. |
| All-Cause Mortality at 30 Days | 30 days (± 5 days) | — |
| Rate of Excellent Functional Outcome (mRS 0-1) at 30 Days | 30 days (± 5 days) | Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 1 |
| Rate of Functional Independence (mRS 0-2) at 30 Days | 30 days (± 5 days) | Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 2. |
| Quality of Life Assessment using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at 30 Days | 30 days (± 5 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. |
| Rate of Excellent Functional Outcome (mRS 0-1) at 90 Days | 90 days (± 7 days) | Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 1. |
| Rate of Functional Independence (mRS 0-2) at 90 Days | 90 days (± 7 days) | Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 2. |
| Quality of Life Assessment using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at 90 Days | 90 days (± 7 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. |
| Incidence of Symptomatic Intracranial Hemorrhage | Post-procedure 72 hours (± 12 hours) | — |
| Incidence of Any Intracranial Hemorrhage | Post-procedure 72 hours (± 12 hours) | — |
| Incidence of Adverse Events (AEs) | Through study completion, up to 90 days | Number of participants with adverse events. |
| Incidence of Serious Adverse Events (SAEs) | Through study completion, up to 90 days | Number of participants with serious adverse events. |
Countries
China
Contacts
CONTACTXiaochuan Huo, Doctor, Doctor
CONTACTXin Tong, Doctor
Outcome results
None listed