A Randomized Trial of Carotid Artery Stenting With Balloon Guide Catheter

NCT07678164 | Not Yet Recruiting

• 1 other identifier: BGC-2026-01
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Carotid Artery Stenosis

Keywords

balloon guide catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Device Success Rate

  during the procedure

• Incidence of Major Adverse Events (MAE) within 30 days, including any stroke, death, and myocardial infarction.

  within 30-day post-procedure

• Changes in mRS score at 30 days and 90 days post-procedure.

  30 days and 90 days post-procedure

• Incidence of ipsilateral target vessel stroke at 30 days and 90 days post-procedure.

  30 days and 90 days post-procedure

• Incidence of transient ischemic attacks (TIA) at 30 days and 90 days post-procedure.

  30 days and 90 days post-procedure

Study Arms (2)

Combined Cerebral Protection (BGC + Filter + intermediate catheter)

EXPERIMENTAL

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

Standard Protection Group (Filter Alone)

ACTIVE COMPARATOR

Participants in this arm will undergo carotid artery stenting (CAS) with distal filter protection.

Device: Filter

Interventions

Balloon Guide Catheter DEVICE

Balloon guide catheter for proximal flow arrest and debris aspiration during carotid stenting.

Combined Cerebral Protection (BGC + Filter + intermediate catheter)

Filter DEVICE

Distal embolic filter deployed beyond the stenosis to capture debris during stent placement.

Standard Protection Group (Filter Alone)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hebei General Hospital: lead

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Guodong Xu

  Hebei General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Zhao

CONTACT

185 0327 2089; zhaoyan2333@163.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: Chief physician

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06