Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting

NCT07247864 | Recruiting DMC

• 1 other identifier: KS2025109
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

Brief 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. 1.Combined Protection Group: Receiving CAS using a Balloon Guide Catheter combined with a distal filter.
2. 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

Keywords

Carotid artery stenosis; Carotid Artery Stenting; Balloon Guide Catheter; Embolic Protection Device; New Ischemic Lesions

Outcome Measures

Primary Outcomes (1)

• Number of New Ischemic Lesions on Diffusion-Weighted Imaging (DWI)

  Assessed by brain MRI (DWI sequences) performed within 72 hours post-procedure. The outcome is defined as the total number of new high-signal intensity lesions observed on the post-procedural DWI compared to pre-procedural baseline (if available) or recognized as new procedural emboli.

  Post-procedure 72 hours (plus or minus 12 hours)

Secondary Outcomes (15)

• Procedural Success Rate

  Intra-operative

• Total Volume of New Ischemic Lesions on DWI

  Post-procedure 72 hours (± 12 hours)

• Incidence of New Symptomatic Ischemic Stroke

  Post-procedure 72 hours (± 12 hours)

• Rate of Early Neurological Deterioration (NIHSS Worsening)

  Post-procedure 72 hours (± 12 hours)

• All-Cause Mortality at 30 Days

  30 days (± 5 days)

Study Arms (2)

Combined Protection Group (BGC + Filter)

EXPERIMENTAL

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.

Device: Balloon Guide Catheter; Device: Distal Filter Protection Device

Standard Protection Group (Filter Alone)

ACTIVE COMPARATOR

Patients in this group will undergo carotid artery stenting (CAS) using a standard guiding catheter and a distal filter protection device alone.

Device: Distal Filter Protection Device

Interventions

Balloon Guide Catheter DEVICE

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

Also known as: BGC

Combined Protection Group (BGC + Filter)

Distal Filter Protection Device DEVICE

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

Also known as: Embolic Protection Device, EPD

Combined Protection Group (BGC + Filter); Standard Protection Group (Filter Alone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Occlusion of the contralateral internal carotid artery (ICA).
• Severe stenosis of the contralateral common carotid artery (CCA) or internal carotid artery (ICA).
• Occlusion of the ipsilateral external carotid artery (ECA).
• Severe stenosis of the ipsilateral intracranial segment of the internal carotid artery.
• Severe stenosis of the vertebrobasilar artery system (excluding non-dominant vertebral artery).
• History of previous stenting in the head or neck vessels.
• Presence of other cerebrovascular diseases, such as intracranial aneurysms \> 5 mm or vascular malformations.
• Stroke onset within the last 7 days.
• Pregnant or lactating women.
• Known allergy to contrast media or stent materials (e.g., Nitinol).
• Previous large cerebral infarction with sequelae that would interfere with the assessment of endpoint events.
• Absolute or relative contraindications to antiplatelet therapy.
• Clear risk of cardioembolism (e.g., atrial fibrillation, atrial flutter, intracardiac thrombus) or clear indication for anticoagulation therapy.
• Life expectancy of less than 1 year.
• Pre-existing neurological or psychiatric diseases that would confound neurological assessment (e.g., severe dementia).

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 101118, China

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Embolic Protection Devices

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Xiaochuan Huo, Doctor, Doctor

CONTACT

+86 13716292262; hxc810909@163.com

Xin Tong, Doctor

CONTACT

+86 17810651085; tomice123@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CN (1)