Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting (ANGEL-BEACON)

December 9, 2025 updated by: Xiaochuan Huo, Beijing Anzhen Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

296

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Xiaochuan Huo, Doctor, Doctor
  • Phone Number: +86 13716292262
  • Email: hxc810909@163.com

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 101118
        • Recruiting
        • Beijing Anzhen Hospital Affiliated to Capital Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 years or older.

  2. 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.

  3. Pre-treatment Modified Rankin Scale (mRS) score of 0 to 1.
  4. Scheduled for carotid artery stenting (CAS) as determined by the clinical team.
  5. Signed informed consent provided by the patient or their legal representative.

Exclusion Criteria:

  1. Occlusion of the contralateral internal carotid artery (ICA).
  2. Severe stenosis of the contralateral common carotid artery (CCA) or internal carotid artery (ICA).
  3. Occlusion of the ipsilateral external carotid artery (ECA).
  4. Severe stenosis of the ipsilateral intracranial segment of the internal carotid artery.
  5. Severe stenosis of the vertebrobasilar artery system (excluding non-dominant vertebral artery).
  6. History of previous stenting in the head or neck vessels.
  7. Presence of other cerebrovascular diseases, such as intracranial aneurysms > 5 mm or vascular malformations.
  8. Stroke onset within the last 7 days.
  9. Pregnant or lactating women.
  10. Known allergy to contrast media or stent materials (e.g., Nitinol).
  11. Previous large cerebral infarction with sequelae that would interfere with the assessment of endpoint events.
  12. Absolute or relative contraindications to antiplatelet therapy.
  13. Clear risk of cardioembolism (e.g., atrial fibrillation, atrial flutter, intracardiac thrombus) or clear indication for anticoagulation therapy.
  14. Life expectancy of less than 1 year.
  15. Pre-existing neurological or psychiatric diseases that would confound neurological assessment (e.g., severe dementia).
  16. Severe renal insufficiency (Glomerular Filtration Rate [GFR] < 30 ml/min).
  17. Contraindications to Magnetic Resonance Imaging (MRI).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Balloon Guide Catheter
A catheter with a balloon at the distal tip, used to temporarily arrest flow and aspirate debris during the stenting procedure.
Other Names:
  • BGC
Device: Distal Filter Protection Device
A mesh-type device deployed distally to the stenosis to capture embolic debris during the procedure.
Other Names:
  • Embolic Protection Device
  • EPD
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.
Device: Distal Filter Protection Device
A mesh-type device deployed distally to the stenosis to capture embolic debris during the procedure.
Other Names:
  • Embolic Protection Device
  • EPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of New Ischemic Lesions on Diffusion-Weighted Imaging (DWI)
Time Frame: Post-procedure 72 hours (plus or minus 12 hours)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural Success Rate
Time Frame: Intra-operative
Defined as the successful deployment and retrieval of the stent and protection devices (Balloon Guide Catheter and/or Distal Filter) without technical failure.
Intra-operative
Total Volume of New Ischemic Lesions on DWI
Time Frame: Post-procedure 72 hours (± 12 hours)
The total volume (in milliliters) of new ischemic lesions measured on DWI MRI.
Post-procedure 72 hours (± 12 hours)
Incidence of New Symptomatic Ischemic Stroke
Time Frame: Post-procedure 72 hours (± 12 hours)
Occurrence of a new ischemic stroke presenting with clinical symptoms.
Post-procedure 72 hours (± 12 hours)
Rate of Early Neurological Deterioration (NIHSS Worsening)
Time Frame: Post-procedure 72 hours (± 12 hours)
Defined as an increase in the National Institutes of Health Stroke Scale (NIHSS) score of > 2 points compared to baseline.
Post-procedure 72 hours (± 12 hours)
All-Cause Mortality at 30 Days
Time Frame: 30 days (± 5 days)
30 days (± 5 days)
Rate of Excellent Functional Outcome (mRS 0-1) at 30 Days
Time Frame: 30 days (± 5 days)
Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 1
30 days (± 5 days)
Rate of Functional Independence (mRS 0-2) at 30 Days
Time Frame: 30 days (± 5 days)
Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 2.
30 days (± 5 days)
Rate of Excellent Functional Outcome (mRS 0-1) at 90 Days
Time Frame: 90 days (± 7 days)
Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 1.
90 days (± 7 days)
Rate of Functional Independence (mRS 0-2) at 90 Days
Time Frame: 90 days (± 7 days)
Proportion of patients with a Modified Rankin Scale (mRS) score of 0 to 2.
90 days (± 7 days)
Incidence of Symptomatic Intracranial Hemorrhage
Time Frame: Post-procedure 48 hours (± 12 hours)
Post-procedure 48 hours (± 12 hours)
Incidence of Any Intracranial Hemorrhage
Time Frame: Post-procedure 48 hours (± 12 hours)
Post-procedure 48 hours (± 12 hours)
Incidence of Adverse Events (AEs)
Time Frame: Through study completion, up to 90 days
Number of participants with adverse events.
Through study completion, up to 90 days
Incidence of Serious Adverse Events (SAEs)
Time Frame: Through study completion, up to 90 days
Number of participants with serious adverse events.
Through study completion, up to 90 days
Quality of Life Assessment using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at 30 Days
Time Frame: 30 days (± 5 days)
The EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels. The responses are converted into a single utility index score (ranging from less than 0 to 1, where 1 indicates full health and 0 indicates dead). Higher scores indicate better health-related quality of life.
30 days (± 5 days)
Quality of Life Assessment using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at 90 Days
Time Frame: 90 days (± 7 days)
The EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels. The responses are converted into a single utility index score (ranging from less than 0 to 1, where 1 indicates full health and 0 indicates dead). Higher scores indicate better health-related quality of life.
90 days (± 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Estimated)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS2025109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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