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NCT Number: NCT07247864

Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Pre-specified subgroup analyses will be conducted based on baseline symptom status (symptomatic vs. asymptomatic carotid artery stenosis) and stent design (open-cell vs. closed-cell).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Occlusion or severe stenosis (70% or greater) of the intracranial segment of the ipsilateral internal carotid artery system;
  • Occlusion or severe stenosis (70% or greater) of the contralateral common carotid artery or internal carotid artery;
  • History of stenting in the head and neck vessels within 3 months;
  • Coexisting other cerebrovascular diseases, such as intracranial aneurysms greater than 5 mm or cerebrovascular malformations;
  • Onset of stroke within 7 days;
  • Large old infarctions from previous stroke that may confound the evaluation of endpoints;
  • Contraindications to magnetic resonance imaging (MRI);
  • Definite risk of cardiogenic embolism (e.g., atrial fibrillation, atrial flutter, intracardiac thrombus) or clear indications for anticoagulation therapy;
  • Absolute or relative contraindications to antiplatelet therapy;
  • Pregnant or lactating women;
  • Allergy or hypersensitivity to contrast media or stent materials (e.g., Nitinol);
  • Life expectancy less than 1 year;
  • Pre-existing neurological or psychiatric disorders (e.g., severe dementia) that would confound neurological assessments;
  • Severe renal insufficiency (eGFR less than 30 mL/min).

Treatment and study plan

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.

Other names: BGC

Distal Filter Protection Device

Device

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

Other names: Embolic Protection Device, EPD

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Incidence of New Symptomatic Ischemic Stroke

    Time frame: Post-procedure 72 hours (± 12 hours)

    Occurrence of a new ischemic stroke presenting with clinical symptoms.

  4. 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.

  5. All-Cause Mortality at 30 Days

    Time frame: 30 days (± 5 days)

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Incidence of Symptomatic Intracranial Hemorrhage

    Time frame: Post-procedure 72 hours (± 12 hours)

  13. Incidence of Any Intracranial Hemorrhage

    Time frame: Post-procedure 72 hours (± 12 hours)

  14. Incidence of Adverse Events (AEs)

    Time frame: Through study completion, up to 90 days

    Number of participants with adverse events.

  15. Incidence of Serious Adverse Events (SAEs)

    Time frame: Through study completion, up to 90 days

    Number of participants with serious adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaochuan Huo, Doctor, Doctor

CONTACT

[email protected]

+86 13716292262

Xin Tong, Doctor

CONTACT

[email protected]

+86 17810651085

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

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

Acronym: ANGEL-BEACON

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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