A Carotid Stenting Boston Scientific Surveillance Program (CABANA)

Boston Scientific

Status and phase

Completed

Phase 4

Conditions

Carotid Artery Disease

Treatments

Device: FilterWire EZ™ System™

Device: Carotid WALLSTENT Monorail Endoprosthesis

Study type

Interventional

Funder types

Industry

Identifiers

NCT00741091

S2029

Details and patient eligibility

About

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.

Enrollment

1,097 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who requires carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.
Subject with neurological symptoms and greater than or equal to 50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram OR
Subjects without neurological symptoms and greater than or equal to 80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram.
Subject has a reference vessel diameter greater than or equal to 4.0 mm and less than or equal to 9.0 mm at the target lesion and a vessel diameter distal to the target lesion of greater than or equal to 3.5 mm and less than or equal to 5.5 mm as optimal "landing zone" for placement of the FilterWire EZ System.
Subject is willing and able to comply with all follow-up requirements.
Subject has provided a signed informed consent prior to participation in the Registry.

Exclusion criteria

Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated
Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system
Patients with uncorrected bleeding disorders
Lesions in the ostium of the common carotid artery.