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
Qualifiers
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
Treatments tested in this trial
- Balloon Guide Catheter
- Filter
Treatment groups
132 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov