Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting
A Comparative Study of Carotid Artery Stenosis Stenting With Balloon Guide Catheter Combined With Distal Filter Versus Distal Filter Alone-A Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study
Beijing Anzhen Hospital
296 participants
Dec 3, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- Age 18 years or older.
- Diagnosis of extracranial carotid artery stenosis meeting one of the following criteria (measured by DSA or CTA using NASCET criteria):
- Symptomatic: TIA or non-disabling stroke in the ipsilateral carotid distribution within the past 6 months, with stenosis ≥ 50%.
- Asymptomatic: Stenosis ≥ 70%, with indication for interventional therapy.
- Pre-treatment Modified Rankin Scale (mRS) score of 0 to 1.
- Scheduled for carotid artery stenting (CAS) as determined by the clinical team.
- Signed informed consent provided by the patient or their legal representative.
Exclusion Criteria17
- Occlusion of the contralateral internal carotid artery (ICA).
- Severe stenosis of the contralateral common carotid artery (CCA) or internal carotid artery (ICA).
- Occlusion of the ipsilateral external carotid artery (ECA).
- Severe stenosis of the ipsilateral intracranial segment of the internal carotid artery.
- Severe stenosis of the vertebrobasilar artery system (excluding non-dominant vertebral artery).
- History of previous stenting in the head or neck vessels.
- Presence of other cerebrovascular diseases, such as intracranial aneurysms \> 5 mm or vascular malformations.
- Stroke onset within the last 7 days.
- Pregnant or lactating women.
- Known allergy to contrast media or stent materials (e.g., Nitinol).
- Previous large cerebral infarction with sequelae that would interfere with the assessment of endpoint events.
- Absolute or relative contraindications to antiplatelet therapy.
- Clear risk of cardioembolism (e.g., atrial fibrillation, atrial flutter, intracardiac thrombus) or clear indication for anticoagulation therapy.
- Life expectancy of less than 1 year.
- Pre-existing neurological or psychiatric diseases that would confound neurological assessment (e.g., severe dementia).
- Severe renal insufficiency (Glomerular Filtration Rate \[GFR\] \< 30 ml/min).
- Contraindications to Magnetic Resonance Imaging (MRI).
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07247864