N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Not applicable ClinicalTrials.gov

Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting

Sponsor: Beijing Anzhen Hospital • ClinicalTrials.gov ID: NCT07247864

Registry updated: 2026-09-02
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • 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.

Eligibility criteria

Inclusion Criteria： 1. Age 18 years or older; 2. 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); 3. Pre-treatment modified Rankin Scale (mRS) score of 0 to 1; 4. Planned for stent treatment by the clinical care team; 5. Informed consent obtained from the patient or their legally authorized representative. Exclusion Criteria： 1. Occlusion or severe stenosis (70% or greater) of the intracranial segment of the ipsilateral internal carotid artery system; 2. Occlusion or severe stenosis (70% or greater) of the contralateral common carotid artery or internal carotid artery; 3. History of stenting in the head and neck vessels within 3 months; 4. Coexisting other cerebrovascular diseases, such as intracranial aneurysms greater than 5 mm or cerebrovascular malformations; 5. Onset of stroke within 7 days; 6. Large old infarctions from previous stroke that may confound the evaluation of endpoints; 7. Contraindications to magnetic resonance imaging (MRI); 8. Definite risk of cardiogenic embolism (e.g., atrial fibrillation, atrial flutter, intracardiac thrombus) or clear indications for anticoagulation therapy; 9. Absolute or relative contraindications to antiplatelet therapy; 10. Pregnant or lactating women; 11. Allergy or hypersensitivity to contrast media or stent materials (e.g., Nitinol); 12. Life expectancy less than 1 year; 13. Pre-existing neurological or psychiatric disorders (e.g., severe dementia) that would confound neurological assessments; 14. Severe renal insufficiency (eGFR less than 30 mL/min).

Conditions

Carotid Artery Stenosis

Locations

  • Beijing Anzhen Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record