Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting

Official 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

Overview

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.

Detailed description

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).

Interventions

• 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.
• Device Distal Filter Protection Device
  A mesh-type device deployed distally to the stenosis to capture embolic debris during the procedure.

Primary outcome measures

• Number of New Ischemic Lesions on Diffusion-Weighted Imaging (DWI) [Time frame: Post-procedure 72 hours (plus or minus 12 hours)]

Secondary outcome measures (12)

• Procedural Success Rate [Time frame: Intra-operative]
• Total Volume of New Ischemic Lesions on DWI [Time frame: Post-procedure 72 hours (± 12 hours)]
• Incidence of New Symptomatic Ischemic Stroke [Time frame: Post-procedure 72 hours (± 12 hours)]
• Rate of Early Neurological Deterioration (NIHSS Worsening) [Time frame: Post-procedure 72 hours (± 12 hours)]
• All-Cause Mortality at 30 Days [Time frame: 30 days (± 5 days)]
• Rate of Excellent Functional Outcome (mRS 0-1) at 30 Days [Time frame: 30 days (± 5 days)]
• Rate of Functional Independence (mRS 0-2) at 30 Days [Time frame: 30 days (± 5 days)]
• Quality of Life Assessment using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at 30 Days [Time frame: 30 days (± 5 days)]
• Rate of Excellent Functional Outcome (mRS 0-1) at 90 Days [Time frame: 90 days (± 7 days)]
• Rate of Functional Independence (mRS 0-2) at 90 Days [Time frame: 90 days (± 7 days)]
• Quality of Life Assessment using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at 90 Days [Time frame: 90 days (± 7 days)]
• Incidence of Symptomatic Intracranial Hemorrhage [Time frame: Post-procedure 72 hours (± 12 hours)]

Eligibility criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Anzhen Hospital Affiliated to Capital Medical University — Beijing

Identifiers

NCT: NCT07247864 · KS2025109

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗