RecruitingNot ApplicableNCT07247864

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


Sponsor

Beijing Anzhen Hospital

Enrollment

296 participants

Start Date

Dec 3, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Balloon Guide Catheter and Distal Filter Protection Device for people with carotid artery stenosis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

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NCT07247864


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