A Randomized Trial of Carotid Artery Stenting With Balloon Guide Catheter

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Device: Balloon Guide Catheter; Device: Filter

Detailed Description

Carotid artery stenting (CAS) is an established treatment for carotid stenosis, yet the optimal cerebral embolic protection strategy remains uncertain. This prospective, multicenter, randomized, open-label, controlled trial will enroll 132 patients with symptomatic (≥50%) or asymptomatic (≥70%) carotid stenosis, who will be randomly assigned 1:1 to either experimental multimodal protection (Balloon Guide Catheter plus distal filter and intermediate catheter aspiration) or conventional distal filter protection alone. The primary endpoint is the number of new infarcts on post-procedural diffusion-weighted imaging (DWI) assessed within 48 hours (±24 hours), with secondary endpoints including device success and defect rates, incidences of symptomatic and all intracranial hemorrhage within 48 hours post-procedure, ipsilateral target-vessel stroke, TIA, major adverse events (stroke/death/MI), and adverse/serious adverse events at 30 and 90 days, all-cause mortality at 90 days, changes in mRS score at 30 and 90 days, and procedure-related complications (e.g., dissection, hyperperfusion syndrome).

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Zhao; Phone Number: 185 0327 2089; Email: zhaoyan2333@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged between 18 and 80 years (inclusive), with no gender restriction.
2. Imaging diagnosis indicates symptomatic carotid artery stenosis (by NASCET method) ≥50% or asymptomatic carotid artery stenosis (by NASCET method) ≥70%.
3. Suitable for carotid artery stenting.
4. Good compliance, voluntarily signed the informed consent form, and able to follow up as required.

Exclusion Criteria:

1. Severe tortuosity or calcification of the diseased vessel, preventing device delivery.
2. Patients with ipsilateral external carotid artery occlusion or severe stenosis of the intracranial segment of the internal carotid artery.
3. Patients with contralateral common carotid artery occlusion or severe stenosis or occlusion of the internal carotid artery.
4. Patients with severe stenosis or occlusion of the vertebrobasilar artery (excluding non-dominant vertebral artery).
5. Spontaneous intracranial hemorrhage, massive cerebral infarction, progressive stroke, or myocardial infarction within the past 3 months.
6. Presence of substantial acute or subacute thrombus adjacent to the lesion.
7. mRS > 3.
8. Patients with a clear risk of cardioembolism, such as atrial fibrillation, or those with definite indications for anticoagulation.
9. Chronic obstructive pulmonary disease requiring long-term continuous oxygen therapy.
10. Patients with prior stent treatment in the ipsilateral head and neck vessels.
11. Patients with end-stage renal failure requiring dialysis.
12. Life expectancy less than 6 months.
13. Patients unsuitable for magnetic resonance imaging (MRI) for any reason.
14. Patients with absolute or relative contraindications to antiplatelet therapy.
15. Inability to cooperate with the study due to dementia or mental disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined Cerebral Protection (BGC + Filter + intermediate catheter); Participants in this arm will undergo carotid artery stenting (CAS) with a multimodal cerebral embolic protection strategy, incorporating proximal balloon occlusion via a Balloon Guide Catheter (BGC), distal filter protection, and active aspiration through an intermediate catheter.	Device: Balloon Guide Catheter; Balloon guide catheter for proximal flow arrest and debris aspiration during carotid stenting.
Active Comparator: Standard Protection Group (Filter Alone); Participants in this arm will undergo carotid artery stenting (CAS) with distal filter protection.	Device: Filter; Distal embolic filter deployed beyond the stenosis to capture debris during stent placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure	Total number of new DWI positive lesions on post procedural brain MRI within 48 hours (±24 hours). New lesions are defined as foci of hyperintensity not seen on baseline DWI (if available), or otherwise as lesions consistent with acute embolic infarction.	within 48 hours (±24 hours) post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success Rate	Device success for the balloon dilation catheter is defined as successful delivery, complete inflation, and smooth retrieval of the catheter system.	during the procedure
Incidence of Major Adverse Events (MAE) within 30 days, including any stroke, death, and myocardial infarction.	The rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke, or myocardial infarction within 30-day post-procedure.	within 30-day post-procedure
Changes in mRS score at 30 days and 90 days post-procedure.	Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death).	30 days and 90 days post-procedure
Incidence of ipsilateral target vessel stroke at 30 days and 90 days post-procedure.	Stroke is defined as an acute neurological deficit of vascular origin lasting ≥24 hours, or lasting <24 hours with neuroimaging evidence of new infarction, occurring in the territory of the treated carotid artery.	30 days and 90 days post-procedure
Incidence of transient ischemic attacks (TIA) at 30 days and 90 days post-procedure.	Transient ischemic attacks (TIA) was defined as transient focal neurological deficit of vascular origin lasting <24 hours with no acute infarct on neuroimaging.	30 days and 90 days post-procedure
Incidence of Procedure-related complications (e.g., vessel dissection, hyperperfusion syndrome, etc.).	Procedure related complications include vessel dissection, hyperperfusion syndrome, access site events, and other adverse events directly attributable to carotid artery stenting (CAS).	during the procedure
Incidence of adverse events and serious adverse events at 30 days and 90 days post-procedure.	The Incidence of Adverse events or severe adverse event at 30 days and 90 days post-procedure.	30 days and 90 days post-procedure
Incidence of symptomatic intracranial hemorrhage within 48 hours (±24 hours) post-procedure.	Symptomatic intracranial hemorrhage defined as any intracranial hemorrhage on imaging with new neurological symptoms or NIHSS increase ≥4, or death.	within 48 hours (±24 hours) post-procedure
Incidence of intracranial hemorrhage within 48 hours (±24 hours) post-procedure.	Incidence of all intracranial hemorrhage on post-procedural brain imaging within 48 hours.	within 48 hours (±24 hours) post-procedure
Incidence of all-cause mortality within 90 days post-procedure.	Incidence of death from any cause occurring within 90 days following the procedure.	90 days post-procedure
Incidence of device defects.	The Incidence of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc.	during the procedure

Collaborators and Investigators

• Sponsor: Hebei General Hospital
• Investigators: Principal Investigator: Guodong Xu, Hebei General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: balloon guide catheter
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: BGC-2026-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No