Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA
NCT ID: NCT00478673
Last Updated: 2012-08-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
298 participants
INTERVENTIONAL
2007-05-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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NexStent Carotid Stent System (Monorail Delivery System)
Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
FilterWire EZ™ Embolic Protection System
Used as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Subbarao Myla, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hoag Memorial Hospital
Pamela Grady, PhD
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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Huntsville Hospital Heart Center
Huntsville, Alabama, United States
St. Luke's Medical Center
Phoenix, Arizona, United States
Central Cardiology Medical Clinic
Bakersfield, California, United States
Los Angeles Cardiology Associates
Los Angeles, California, United States
ACS Research Group, Inc.
Mountain View, California, United States
Hoag Memorial Hospital / Presbyterian
Newport Beach, California, United States
Salinas Valley Memorial Healthcare System
Salinas, California, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
JFK Medical Center
Atlantis, Florida, United States
Northwest Medical Center
Margate, Florida, United States
Baptist Cardiac and Vascular Institute, Baptist Hospital of Miami
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Neurological Institute of Savannah
Savannah, Georgia, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Prairie Education & Research Cooperative
Springfield, Illinois, United States
Northern Indiana Research Alliance
Fort Wayne, Indiana, United States
The Indiana Heart Hospital
Indianapolis, Indiana, United States
Terrebonne General Medical Center
Houma, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Willis Knighton Medical Center
Shreveport, Louisiana, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Caritas St. Elizabeth's Medical Center
Brighton, Massachusetts, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Great Lakes Heart & Vascular Institute
Saint Joseph, Michigan, United States
Providence Hospital
Southfield, Michigan, United States
Michigan Heart PC
Ypsilanti, Michigan, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Washington University in St. Louis
St Louis, Missouri, United States
St. Anthony's Medical Center
St Louis, Missouri, United States
Our Lady of Lourdes Medical Center
Camden, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Morristown Memorial
Morristown, New Jersey, United States
New Mexico Heart Institute, PA
Albuquerque, New Mexico, United States
Albany Medical Center Hospital
Albany, New York, United States
Kaleida Health
Buffalo, New York, United States
Lenox Hill Hospital
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Buffalo Neurosurgery Group
Williamsville, New York, United States
Cleveland Clinic and Foundation
Cleveland, Ohio, United States
Ohio State University Medical
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Oklahoma Heart
Oklahoma City, Oklahoma, United States
Heritage Valley Health System
Beaver, Pennsylvania, United States
Geisinger Clinic
Danville, Pennsylvania, United States
Center PA Cardiovascular Research Institute
Harrisburg, Pennsylvania, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
St. Mary Medical Center
Yardley, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
South Carolina Heart Center
Columbia, South Carolina, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
Cardiovascular Associates, PC Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Dallas Fort Worth Vascular
Dallas, Texas, United States
Presbyterian Hospital of Dallas
Dallas, Texas, United States
Heart Center of North Texas
Fort Worth, Texas, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
Central Cardiovaascular Research Foundation
San Antonio, Texas, United States
Washington Cardiovscular Research and Education Foundation
Seattle, Washington, United States
St. Joseph Regional Medical Center
Milwaukee, Wisconsin, United States
Countries
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References
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Qureshi AI, Knape C, Maroney J, Suri MF, Hopkins LN. Multicenter clinical trial of the NexStent coiled sheet stent in the treatment of extracranial carotid artery stenosis: immediate results and late clinical outcomes. J Neurosurg. 2003 Aug;99(2):264-70. doi: 10.3171/jns.2003.99.2.0264.
Other Identifiers
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SONOMA
Identifier Type: -
Identifier Source: secondary_id
S2042
Identifier Type: -
Identifier Source: org_study_id