Actively Recruiting
Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting
Led by Beijing Anzhen Hospital · Updated on 2025-12-16
296
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of extracranial carotid artery stenosis with either symptomatic stenosis (≥50%) within past 6 months or asymptomatic stenosis (≥70%) requiring treatment
- Pre-treatment Modified Rankin Scale score of 0 to 1
- Scheduled for carotid artery stenting as planned by clinical team
- Signed informed consent provided by the patient or legal representative
You will not qualify if you...
- Occlusion of the contralateral internal carotid artery
- Severe stenosis of contralateral common or internal carotid artery
- Occlusion of ipsilateral external carotid artery
- Severe stenosis of ipsilateral intracranial internal carotid artery
- Severe stenosis of vertebrobasilar artery system (excluding non-dominant vertebral artery)
- History of previous stenting in head or neck vessels
- Other cerebrovascular diseases such as intracranial aneurysms larger than 5 mm or vascular malformations
- Stroke onset within the last 7 days
- Pregnant or lactating women
- Known allergy to contrast media or stent materials (e.g., Nitinol)
- Previous large cerebral infarction causing assessment interference
- Contraindications to antiplatelet therapy
- Clear risk of cardioembolism or indication for anticoagulation therapy
- Life expectancy less than 1 year
- Pre-existing neurological or psychiatric conditions affecting neurological assessment
- Severe renal insufficiency (GFR less than 30 ml/min)
- Contraindications to MRI
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 101118
Actively Recruiting
Research Team
X
Xiaochuan Huo, Doctor, Doctor
CONTACT
X
Xin Tong, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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