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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older.

• Diagnosis of extracranial carotid artery stenosis meeting one of the following criteria (measured by DSA or CTA using NASCET criteria):

• Symptomatic: TIA or non-disabling stroke in the ipsilateral carotid distribution within the past 6 months, with stenosis ≥ 50%.

• Asymptomatic: Stenosis ≥ 70%, with indication for interventional therapy.

• Pre-treatment Modified Rankin Scale (mRS) score of 0 to 1.

• Scheduled for carotid artery stenting (CAS) as determined by the clinical team.

• Signed informed consent provided by the patient or their legal representative.

Locations
Other Locations
China
Beijing Anzhen Hospital Affiliated to Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Xiaochuan Huo, Doctor, Doctor
hxc810909@163.com
+86 13716292262
Backup
Xin Tong, Doctor
tomice123@foxmail.com
+86 17810651085
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 296
Treatments
Experimental: Combined Protection Group (BGC + Filter)
Patients in this group will undergo carotid artery stenting (CAS) using a Balloon Guide Catheter (BGC) for proximal protection combined with a distal filter protection device.
Active_comparator: Standard Protection Group (Filter Alone)
Patients in this group will undergo carotid artery stenting (CAS) using a standard guiding catheter and a distal filter protection device alone.
Sponsors
Leads: Beijing Anzhen Hospital

This content was sourced from clinicaltrials.gov