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Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting

NCT07247864 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2025-12-16

No results posted yet for this 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.

Conditions

  • Carotid Artery Stenosis

Interventions

DEVICE

Balloon Guide Catheter

A catheter with a balloon at the distal tip, used to temporarily arrest flow and aspirate debris during the stenting procedure.

DEVICE

Distal Filter Protection Device

A mesh-type device deployed distally to the stenosis to capture embolic debris during the procedure.

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-03
Primary Completion
2027-09-01
Completion
2027-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07247864 on ClinicalTrials.gov