Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting
NCT ID: NCT07247864
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
296 participants
INTERVENTIONAL
2025-12-03
2027-12-01
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Combined Protection Group (BGC + Filter)
Patients in this group will undergo carotid artery stenting (CAS) using a Balloon Guide Catheter (BGC) for proximal protection combined with a distal filter protection 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.
Distal Filter Protection Device
A mesh-type device deployed distally to the stenosis to capture embolic debris during the procedure.
Standard Protection Group (Filter Alone)
Patients in this group will undergo carotid artery stenting (CAS) using a standard guiding catheter and a distal filter protection device alone.
Distal Filter Protection Device
A mesh-type device deployed distally to the stenosis to capture embolic debris during the procedure.
Interventions
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Balloon Guide Catheter
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
A mesh-type device deployed distally to the stenosis to capture embolic debris during the procedure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Beijing Anzhen Hospital
OTHER
Responsible Party
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Xiaochuan Huo
Director
Locations
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Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KS2025109
Identifier Type: -
Identifier Source: org_study_id