A Carotid Stenting Boston Scientific Surveillance Program
NCT ID: NCT00741091
Last Updated: 2011-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1097 participants
INTERVENTIONAL
2008-12-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Registry
Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
Carotid WALLSTENT Monorail Endoprosthesis
A carotid artery stent for use in subjects at high risk for adverse events from Carotid endarterectomy (CEA) due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.
FilterWire EZ™ System™
Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.
Interventions
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Carotid WALLSTENT Monorail Endoprosthesis
A carotid artery stent for use in subjects at high risk for adverse events from Carotid endarterectomy (CEA) due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.
FilterWire EZ™ System™
Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
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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Pamela Grady, Ph.D
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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Baptist Medical Center Princeton
Birmingham, Alabama, United States
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
University of Miami Hospital
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
MediQuest Research Group Inc at Munroe Regional Medical Center
Ocala, Florida, United States
Tallahassee Research Institute, Inc.
Tallahassee, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Piedmont Hospital
Atlanta, Georgia, United States
St. Joseph's Research Institute
Atlanta, Georgia, United States
Vascular Surgical Associates PC
Austell, Georgia, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Peoria Radiology Research & Education Foundation
Peoria, Illinois, United States
St. John's Hospital, Prairie Education and Research Cooperative
Springfield, Illinois, United States
Southern Illinois University - Memorial Medical Center
Springfield, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
The Indiana Heart Hospital
Indianapolis, Indiana, United States
Norton Hospital
Louisville, Kentucky, United States
Physicians and Surgeons Surgical Hospital
Monroe, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Opelousas General Health Center
Opelousas, Louisiana, United States
Southern Maryland Hospital Center
Clinton, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Michigan Vascular Research Center
Flint, Michigan, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
Covenant Medical Center
Saginaw, Michigan, United States
Great Lakes Heart and Vascular
Saint Joseph, Michigan, United States
North Memorial Medical Center
Robbinsdale, Minnesota, United States
Freeman Heart & Vascular Institute
Joplin, Missouri, United States
St. John's Regional Medical Center
Joplin, Missouri, United States
St. Joseph Medical Center
Kansas City, Missouri, United States
The Cardiac Center of Creighton University
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Our Lady of Lourdes Medical Center
Cherry Hill, New Jersey, United States
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
St. Michael's Medical Center
Newark, New Jersey, United States
Overlook Hospital
Short Hills, New Jersey, United States
New Mexico Heart Institute, PA
Albuquerque, New Mexico, United States
Albany Medical Center Hospital
Albany, New York, United States
Maimonides Medical Center
Brooklyn, New York, United States
Kaleida Health
Buffalo, New York, United States
Mercy Hospital of Buffalo
Buffalo, New York, United States
St. Joseph Hospital
Liverpool, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Wake Medical Center
Raleigh, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
Mercy St. Vincent
Toledo, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
Lake West Hospital
Willoughby, Ohio, United States
Oregon Stroke Center
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Central PA Cardiovascular Research Institute
Harrisburg, Pennsylvania, United States
Pennsylvania Hospital of the University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Pinnacle Health at Harrisburg Hospital
Wormleysburg, Pennsylvania, United States
Berks Cardiologists, Ltd.
Wyomissing, Pennsylvania, United States
St. Mary Medical Center
Yardley, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
South Carolina Heart Center
Columbia, South Carolina, United States
University Medical Center - Greenville Memorial Hospital
Greenville, South Carolina, United States
Sanford USD Medical Center - Sanford Clinical Research
Sioux Falls, South Dakota, United States
Erlanger Hospital
Chattanooga, Tennessee, United States
Memorial Hospital
Chattanooga, Tennessee, United States
Cardiovascular Associates PC
Kingsport, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Baptist Hospital West
Knoxville, Tennessee, United States
Baptist Memorial Hospital-Memphis
Memphis, Tennessee, United States
Cardiothoracic and Vascular Surgeons (CTVS)
Austin, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Presbyterian Hospital of Dallas
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Peripheral Vascular Associates
San Antonio, Texas, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
St. Joseph Hospital
Tacoma, Washington, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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References
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Hopkins LN, White CJ, Foster MT, Powell RJ, Zemel G, Diaz-Cartelle J. Carotid artery stenting and patient outcomes: the CABANA surveillance study. Catheter Cardiovasc Interv. 2014 Nov 15;84(6):997-1004. doi: 10.1002/ccd.25578. Epub 2014 Jul 18.
White CJ, Avula SB, Mintz RT, Iskander A, Chervu A, Feldman RL, Schermerhorn ML, Woo HH, Hopkins LN. Carotid artery revascularization with distal protection in high-surgical-risk patients in routine clinical practice: rationale and design of the CABANA safety surveillance program. Catheter Cardiovasc Interv. 2012 Jan 1;79(1):167-73. doi: 10.1002/ccd.23257. Epub 2011 Oct 5.
Other Identifiers
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S2029
Identifier Type: -
Identifier Source: org_study_id
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