Status:
COMPLETED
A Carotid Stenting Boston Scientific Surveillance Program
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Carotid Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
1097 Patients enrolled
Trial Details
Trial ID
NCT00741091
Start Date
December 1 2008
End Date
October 1 2010
Last Update
August 24 2011
Active Locations (112)
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1
Baptist Medical Center Princeton
Birmingham, Alabama, United States, 35211
2
Cardiology Associates of Mobile
Fairhope, Alabama, United States, 36532
3
St. Joseph's Hospital and Medical Center, Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
4
Southern Arizona Vascular Institute
Tucson, Arizona, United States, 85741