Carotid Artery Disease - CABANA

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Trial Sponsor
Boston Scientific

Principal Investigator
Gregory Mishkel, MD

Trial Name
A Carotid Stenting Boston Scientific Surveillance Program
(CABANA).

Purpose
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.

Details
Patients that are considered high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease will be considered for the study.

Phase
Phase IV

Study Type
Interventional

Study Design
Treatment, Open Label, Single Group Assignment

Study Arms
1

Expected Enrollment
1000

Study Start
October 2008

Expected Completion
May 2010

Primary Outcome Measures

• Composite of major adverse events (MAE) defined as center-reported and CE adjudicated death, stroke, and myocardial infarction (MI) within 30 days of procedure.

Secondary Outcome Measures

• Device, procedure, and unrelated adverse events within 30 days
• Target lesion revascularization within 30 days
• System technical success within 30 days
• Device Malfunction within 30 days

Eligibility

Ages Eligible for Study: 18 years or older

Genders Eligible for Study: Both

Inclusion Criteria

• Subjects at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.
• Subjects 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.

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