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A Randomized Trial of Carotid Artery Stenting With Balloon Guide Catheter

NCT07678164 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-07-01

No results posted yet for this study

Summary

This prospective, multicenter, randomized controlled study enrolled patients undergoing carotid artery stenting (CAS) with cerebral embolic protection for carotid artery stenosis. They were randomly assigned to either a combination of proximal balloon occlusion, filter protection, intermediate catheter or filter protection alone. The study included 132 patients, and the primary endpoint was the number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure.

Conditions

  • Carotid Artery Stenosis

Interventions

DEVICE

Balloon Guide Catheter

Balloon guide catheter for proximal flow arrest and debris aspiration during carotid stenting.

DEVICE

Filter

Distal embolic filter deployed beyond the stenosis to capture debris during stent placement.

Sponsors & Collaborators

  • Hebei General Hospital

    lead OTHER

Principal Investigators

  • Guodong Xu · Hebei General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-12-31
Completion
2027-06-30

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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 NCT07678164 on ClinicalTrials.gov