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
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.
• 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.