Balloon guide catheter plus filter protection during carotid artery stenting

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

This trial tests whether adding a balloon guide catheter to the usual distal filter during carotid artery stenting reduces debris-related brain injury in adults with symptomatic (≥50%) or asymptomatic (≥70%) carotid stenosis scheduled for stenting.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 296 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07247864 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, controlled trial compares standard distal filter protection alone versus a combined approach that adds a balloon guide catheter to allow temporary flow arrest and aspiration during carotid artery stenting. Eligible adults have extracranial carotid stenosis (symptomatic ≥50% or asymptomatic ≥70%) and a pre-treatment mRS of 0–1 and are randomized to one of the two protection strategies. The trial focuses on whether the combined technique lowers the risk of dislodged plaque debris causing new clinical strokes or imaging-detected silent brain infarctions around the time of the procedure. Procedures follow standard CAS techniques using the assigned protection devices, with clinical and imaging follow-up to capture periprocedural ischemic events and new lesions.

Who should consider this trial

Good fit: Adults (≥18 years) scheduled for carotid artery stenting with symptomatic ≥50% or asymptomatic ≥70% extracranial carotid stenosis and pre-treatment mRS 0–1 who can provide informed consent.

Not a fit: Patients with contralateral internal carotid occlusion, severe stenoses of other ipsilateral or contralateral neck/intracranial vessels, or those who are not candidates for CAS are unlikely to benefit from the combined protection strategy.

Why it matters

Potential benefit: If successful, the combined protection approach could reduce procedure-related strokes and silent brain infarcts during carotid stenting.

How similar studies have performed: Some prior studies and registries suggest proximal flow arrest or combined embolic protection can lower embolic load, but direct comparisons of balloon guide plus distal filter protection are limited and have shown mixed results.

Eligibility criteria

Inclusion Criteria:

1. Age 18 years or older.
2. Diagnosis of extracranial carotid artery stenosis meeting one of the following criteria (measured by DSA or CTA using NASCET criteria):

   Symptomatic: TIA or non-disabling stroke in the ipsilateral carotid distribution within the past 6 months, with stenosis ≥ 50%.

   Asymptomatic: Stenosis ≥ 70%, with indication for interventional therapy.
3. Pre-treatment Modified Rankin Scale (mRS) score of 0 to 1.
4. Scheduled for carotid artery stenting (CAS) as determined by the clinical team.
5. Signed informed consent provided by the patient or their legal representative.

Exclusion Criteria:

1. Occlusion of the contralateral internal carotid artery (ICA).
2. Severe stenosis of the contralateral common carotid artery (CCA) or internal carotid artery (ICA).
3. Occlusion of the ipsilateral external carotid artery (ECA).
4. Severe stenosis of the ipsilateral intracranial segment of the internal carotid artery.
5. Severe stenosis of the vertebrobasilar artery system (excluding non-dominant vertebral artery).
6. History of previous stenting in the head or neck vessels.
7. Presence of other cerebrovascular diseases, such as intracranial aneurysms \> 5 mm or vascular malformations.
8. Stroke onset within the last 7 days.
9. Pregnant or lactating women.
10. Known allergy to contrast media or stent materials (e.g., Nitinol).
11. Previous large cerebral infarction with sequelae that would interfere with the assessment of endpoint events.
12. Absolute or relative contraindications to antiplatelet therapy.
13. Clear risk of cardioembolism (e.g., atrial fibrillation, atrial flutter, intracardiac thrombus) or clear indication for anticoagulation therapy.
14. Life expectancy of less than 1 year.
15. Pre-existing neurological or psychiatric diseases that would confound neurological assessment (e.g., severe dementia).
16. Severe renal insufficiency (Glomerular Filtration Rate \[GFR\] \< 30 ml/min).
17. Contraindications to Magnetic Resonance Imaging (MRI).

Where this trial is running

Beijing, Beijing Municipality

• Beijing Anzhen Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiaochuan Huo, Doctor, Doctor

Conditions Carotid Artery Stenosis; Carotid artery stenosis; Carotid Artery Stenting; Balloon Guide Catheter; Embolic Protection Device; New Ischemic Lesions