Balloon Guide Catheter: A catheter with a balloon at the distal tip, used to temporarily arrest flow and aspirate debris during the stenting procedure.
Distal Filter Protection Device: A mesh-type device deployed distally to the stenosis to capture embolic debris during the procedure.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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).
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Beijing Anzhen Hospital Affiliated to Capital Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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