NCT00741091

A Carotid Stenting Boston Scientific Surveillance Program

A Carotid Stenting Boston Scientific Surveillance Program Carotid WALLSTENT Monorail Endoprosthesis FilterWire EZ™ Embolic Protection System

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,097 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carotid Artery Disease

Interventions

Type	Name	Description
DEVICE	Carotid WALLSTENT Monorail Endoprosthesis	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.
DEVICE	FilterWire EZ™ System™	Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2008-08-26
• Last updated: 2011-08-24
• Results posted: 2011-08-19

Locations

112 sites across 1 country: United States