Study Comparing Balloon Guide Catheter Plus Filter Versus Filter Alone in Carotid Artery Stenting for Stroke Prevention

What this Trial Is About

Researchers are evaluating a new combined embolic protection strategy during carotid artery stenting CAS to reduce the risk of stroke caused by debris dislodged during the procedure. Carotid artery stenosis, which narrows the arteries supplying blood to the brain, is a major cause of stroke. The trial compares the standard use of a distal filter device with a combined approach using both a Balloon Guide Catheter BGC and a distal filter to better capture debris. Participants will be randomly assigned to one of two groups. One group receives CAS using a Balloon Guide Catheter combined with a distal filter device, which temporarily stops blood flow and allows aspiration of debris. The other group receives CAS using the standard distal filter device alone. Subgroup analyses will also consider symptom status and stent design. The main focus is to measure new ischemic brain lesions within 72 hours after the procedure. Participants will be monitored with brain MRI scans within 72 hours post-procedure to detect new ischemic lesions. Clinical stroke events and neurological function assessments will be tracked over a 90-day follow-up period. Additional evaluations include procedural success, mortality, functional independence, quality of life, and safety measures throughout the study. The total duration of participation covers the procedure and follow-up assessments up to 90 days.

Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting