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;

Symptomatic extracranial carotid artery stenosis (occurrence of transient ischemic attack or non-disabling stroke in the ipsilateral carotid territory within the previous 6 months, with stenosis of 50% or greater) or asymptomatic extracranial carotid artery stenosis (stenosis of 70% or greater) meeting the indications for interventional treatment (stenosis degree measured by the NASCET method);

Pre-treatment modified Rankin Scale (mRS) score of 0 to 1;

Planned for stent treatment by the clinical care team;

Disqualifiers

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;

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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