A Carotid Stenting Boston Scientific Surveillance Program

Completed · Phase 4

Conditions studied: Carotid Artery Disease

In brief

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.

Key facts

Study ID

NCT00741091

Run by

Boston Scientific Corporation

People needed

1097

Starts

2008-12-01

Expected to finish

2010-10-01

Last updated by the study team

2011-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cardiology Associates of Mobile — Fairhope, Alabama, United States
• St. Joseph's Hospital and Medical Center, Barrow Neurological Institute — Phoenix, Arizona, United States
• Southern Arizona Vascular Institute — Tucson, Arizona, United States
• University of Arkansas — Little Rock, Arkansas, United States
• Central Cardiology Medical Clinic — Bakersfield, California, United States
• Los Angeles Cardiology Associates — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Hoag Hospital — Newport Beach, California, United States
• VA Palo Alto Health Care System — Palo Alto, California, United States
• Salinas Valley Memorial Healthcare System — Salinas, California, United States
• University of California, San Francisco — San Francisco, California, United States
• St. Joseph's Medical Center — Stockton, California, United States
• San Ramon Regional Medical Center — Walnut Creek, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Waterbury Hospital — Waterbury, Connecticut, United States
• Christiana Care Cardiovascular Research — Newark, Delaware, United States
• JFK Medical Center — Atlantis, Florida, United States
• Delray Medical Center — Boca Raton, Florida, United States
• Bethesda Memorial Hospital — Boynton Beach, Florida, United States
• Bradenton Cardiology — Bradenton, Florida, United States
• Jim Moran Heart and Vascular Research Institute — Fort Lauderdale, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Aventura Hospital — Hollywood, Florida, United States
• Baptist Medical Center Princeton — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.