At a glance
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A Carotid Stenting Boston Scientific Surveillance Program Carotid WALLSTENT Monorail Endoprosthesis FilterWire EZ™ Embolic Protection System
In Brief
A Phase 4 clinical trial evaluating Carotid WALLSTENT Monorail Endoprosthesis and FilterWire EZ™ System™ for Carotid Artery Disease. Completed, enrolled 1,097 participants across 112 sites.
Detailed Summary
CABANA is a multicenter U.S. surveillance registry that will be conducted to compile early clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice and to assess the adequacy of the Boston Scientific Corporation (BSC) Carotid Stenting Training Program.
Study Details
Timeline
Interventions
A carotid artery stent for use in subjects at high risk for adverse events from Carotid endarterectomy (CEA) due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.
Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.