A Randomized Trial of Carotid Artery Stenting With Balloon Guide Catheter
ConditionCarotid Artery Stenosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHebei General Hospital
About this trial
This prospective, multicenter, randomized controlled study enrolled patients undergoing carotid artery stenting (CAS) with cerebral embolic protection for carotid artery stenosis. They were randomly assigned to either a combination of proximal balloon occlusion, filter protection, intermediate catheter or filter protection alone. The study included 132 patients, and the primary endpoint was the number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18 and 80 years (inclusive), with no gender restriction.
Imaging diagnosis indicates symptomatic carotid artery stenosis (by NASCET method) ≥50% or asymptomatic carotid artery stenosis (by NASCET method) ≥70%.
Suitable for carotid artery stenting.
Good compliance, voluntarily signed the informed consent form, and able to follow up as required.
Disqualifiers
Severe tortuosity or calcification of the diseased vessel, preventing device delivery.
Patients with ipsilateral external carotid artery occlusion or severe stenosis of the intracranial segment of the internal carotid artery.
Patients with contralateral common carotid artery occlusion or severe stenosis or occlusion of the internal carotid artery.
Patients with severe stenosis or occlusion of the vertebrobasilar artery (excluding non-dominant vertebral artery).
Trial design
Design model
Parallel
Treatments tested in this trial
Balloon Guide Catheter
DeviceBalloon guide catheter for proximal flow arrest and debris aspiration during carotid stenting.
Filter
DeviceDistal embolic filter deployed beyond the stenosis to capture debris during stent placement.
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: Combined Cerebral Protection (BGC + Filter + intermediate catheter)Experimental treatment 1 intervention
Group B: Standard Protection Group (Filter Alone)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure
Total number of new DWI positive lesions on post procedural brain MRI within 48 hours (±24 hours). New lesions are defined as foci of hyperintensity not seen on baseline DWI (if available), or otherwise as lesions consistent with acute embolic infarction.
Time frame
within 48 hours (±24 hours) post-procedureSecondary outcomes
1
Device Success Rate
Device success for the balloon dilation catheter is defined as successful delivery, complete inflation, and smooth retrieval of the catheter system.
Time frame
during the procedure2
Incidence of Major Adverse Events (MAE) within 30 days, including any stroke, death, and myocardial infarction.
The rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke, or myocardial infarction within 30-day post-procedure.
Time frame
within 30-day post-procedure3
Changes in mRS score at 30 days and 90 days post-procedure.
Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death).
Time frame
30 days and 90 days post-procedure4
Incidence of ipsilateral target vessel stroke at 30 days and 90 days post-procedure.
Stroke is defined as an acute neurological deficit of vascular origin lasting ≥24 hours, or lasting \<24 hours with neuroimaging evidence of new infarction, occurring in the territory of the treated carotid artery.
Time frame
30 days and 90 days post-procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: