Actively Recruiting
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
Led by Beijing Anzhen Hospital · Updated on 2025-12-16
296
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combined embolic protection approach during carotid artery stenting (CAS) to reduce stroke risk. Carotid artery stenosis can cause strokes, and while stenting helps, it may release plaque debris that can travel to the brain. This trial compares a new method using a Balloon Guide Catheter (BGC) with a standard distal filter, aiming to see if the combined strategy better prevents new brain lesions and stroke events after the procedure. Participants with symptomatic or asymptomatic carotid artery stenosis are randomly assigned to two groups. One group receives CAS with both the Balloon Guide Catheter and a distal filter device, while the other group receives CAS using only the distal filter. The BGC temporarily stops blood flow and allows aspiration of debris during stenting. The study monitors participants for new ischemic brain lesions within 72 hours and clinical stroke events over 90 days. During the study, participants will undergo brain MRI scans within about 72 hours after the procedure to check for new ischemic lesions. Clinical assessments will be performed up to 90 days after stenting to monitor stroke events, neurological function, quality of life, and any adverse events. Various neurological and functional scales, including the Modified Rankin Scale and EuroQol questionnaire, will be used to evaluate outcomes and overall recovery throughout the follow-up period.
CONDITIONS
Brief 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 symptomatic stenosis of 50% or more within the past 6 months or asymptomatic stenosis of 70% or more
- Pre-treatment Modified Rankin Scale (mRS) score of 0 to 1
- Scheduled for carotid artery stenting (CAS)
- Signed informed consent provided by the patient or legal representative
You will not qualify if you...
- Occlusion of the contralateral internal carotid artery (ICA)
- Severe stenosis of the contralateral common carotid artery (CCA) or internal carotid artery (ICA)
- Occlusion of the ipsilateral external carotid artery (ECA)
- Severe stenosis of the ipsilateral intracranial segment of the internal carotid artery
- Severe stenosis of the vertebrobasilar artery system (excluding non-dominant vertebral artery)
- History of previous stenting in the head or neck vessels
- Presence of 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 with sequelae interfering with endpoint assessment
- Contraindications to antiplatelet therapy
- Clear risk of cardioembolism or indication for anticoagulation therapy
- Life expectancy less than 1 year
- Pre-existing neurological or psychiatric diseases confounding assessment
- Severe renal insufficiency (GFR less than 30 ml/min)
- Contraindications to Magnetic Resonance Imaging (MRI)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo carotid artery stenting (CAS) using either a Balloon Guide Catheter combined with a distal filter protection device or a distal filter protection device alone.
1 procedure visit (in-person)
Duration - Up to 90 days
Participants are monitored for new ischemic lesions, neurological status, and functional outcomes after the stenting procedure.
Visits at approximately 48 hours, 72 hours, 30 days, and 90 days post-procedure
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
X
Xin Tong, Doctor
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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