A Carotid Stenting Boston Scientific Surveillance Program
A Carotid Stenting Boston Scientific Surveillance Program
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.
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.