Health TrialsbyHealthPanel

Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting

ConditionCarotid Artery Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Distal Filter Protection Device

    Device

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

Treatment groups

296 Participants
are divided into 2 treatment groups
Group A: Combined Protection Group (BGC + Filter)Experimental treatment 2 interventions
Group B: Standard Protection Group (Filter Alone)Active comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Procedural Success Rate

Defined as the successful deployment and retrieval of the stent and protection devices (Balloon Guide Catheter and/or Distal Filter) without technical failure.

Time frame
Intra-operative
2

Total Volume of New Ischemic Lesions on DWI

The total volume (in milliliters) of new ischemic lesions measured on DWI MRI.

Time frame
Post-procedure 72 hours (± 12 hours)
3

Incidence of New Symptomatic Ischemic Stroke

Occurrence of a new ischemic stroke presenting with clinical symptoms.

Time frame
Post-procedure 72 hours (± 12 hours)
4

Rate of Early Neurological Deterioration (NIHSS Worsening)

Defined as an increase in the National Institutes of Health Stroke Scale (NIHSS) score of \> 2 points compared to baseline.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Anzhen Hospital

Lead sponsor

Source ClinicalTrials.gov
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