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NOT YET RECRUITING
NCT07678164
NA

A Randomized Trial of Carotid Artery Stenting With Balloon Guide Catheter

Sponsor: Hebei General Hospital

View on ClinicalTrials.gov

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.

Official title: Balloon Guide Catheter-Assisted Carotid Artery Stenting With Multimodal Cerebral Protection: A Prospective, Multicenter, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2026-07-01

Completion Date

2027-06-30

Last Updated

2026-07-01

Healthy Volunteers

No

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.