A Carotid Stenting Boston Scientific Surveillance Program
- Conditions
- Carotid Artery Disease
- Interventions
- Device: Carotid WALLSTENT Monorail EndoprosthesisDevice: FilterWire EZ™ System™
- Registration Number
- NCT00741091
- Lead Sponsor
- Boston Scientific Corporation
- 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 practice and to assess the adequacy of the Boston Scientific Corporation (BSC) Carotid Stenting Training Program.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1097
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Registry Carotid WALLSTENT Monorail Endoprosthesis Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice. Registry FilterWire EZ™ System™ Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
- Primary Outcome Measures
Name Time Method Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI) 30 days Number of participants who experienced a major adverse event (MAE) 0-30 days post-procedure. MAE was defined as add death, stroke, and myocardial infarction(MI).
- Secondary Outcome Measures
Name Time Method Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs) 30 days Adverse events, serious and non-serious, were reported by all study centers. Device related adverse events were defined as any adverse event related the study device as determined by the (Principal Investigator)PI. Procedure related adverse events were defined as any adverse event related the study procedure as determine by the PI. Unrelated adverse events were determined by the PI to not be related to the study device or study procedure.
Target Lesion Revascularization 30 days Number of participant with any surgical or percutaneous attempt to revascularize the target lesion after the initial treatment. The target lesion was defined as the stented segment including 0.5 cm at the proximal and distal margins of the stented segment.
System Technical Success 30 days System technical success included successful delivery and deployment of the FilterWire EZ System beyond the target lesion site, delivery and deployment of the Carotid WALLSTENT Endoprosthesis at the intended location, and successful retrieval of the delivery catheter and FilterWire EZ System after stent placement. System technical success rates was calculated based on the number of participants who had both the FilterWire EZ System and Carotid WALLSTENT Endoprosthesis placement attempted.
Device Malfunction 30 days Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.
Trial Locations
- Locations (111)
Presbyterian Hospital of Dallas
🇺🇸Dallas, Texas, United States
Los Angeles Cardiology Associates
🇺🇸Los Angeles, California, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Hoag Hospital
🇺🇸Newport Beach, California, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Cardiology Associates of Mobile
🇺🇸Fairhope, Alabama, United States
Central Cardiology Medical Clinic
🇺🇸Bakersfield, California, United States
Salinas Valley Memorial Healthcare System
🇺🇸Salinas, California, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Delray Medical Center
🇺🇸Boca Raton, Florida, United States
Waterbury Hospital
🇺🇸Waterbury, Connecticut, United States
Southern Maryland Hospital Center
🇺🇸Clinton, Maryland, United States
Aventura Hospital
🇺🇸Hollywood, Florida, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Southern Illinois University - Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Freeman Heart & Vascular Institute
🇺🇸Joplin, Missouri, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Bradenton Cardiology
🇺🇸Bradenton, Florida, United States
Physicians and Surgeons Surgical Hospital
🇺🇸Monroe, Louisiana, United States
Opelousas General Health Center
🇺🇸Opelousas, Louisiana, United States
Great Lakes Heart and Vascular
🇺🇸St. Joseph, Michigan, United States
University Medical Center - Greenville Memorial Hospital
🇺🇸Greenville, South Carolina, United States
University of Miami Hospital
🇺🇸Miami, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
The Indiana Heart Hospital
🇺🇸Indianapolis, Indiana, United States
Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States
Peripheral Vascular Associates
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center San Antonio
🇺🇸San Antonio, Texas, United States
St. Joseph's Hospital and Medical Center, Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Baptist Medical Center Princeton
🇺🇸Birmingham, Alabama, United States
The Cardiac Center of Creighton University
🇺🇸Omaha, Nebraska, United States
Oregon Stroke Center
🇺🇸Portland, Oregon, United States
Southern Arizona Vascular Institute
🇺🇸Tucson, Arizona, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
St. Joseph's Medical Center
🇺🇸Stockton, California, United States
JFK Medical Center
🇺🇸Atlantis, Florida, United States
St. Joseph's Research Institute
🇺🇸Atlanta, Georgia, United States
Jim Moran Heart and Vascular Research Institute
🇺🇸Fort Lauderdale, Florida, United States
York Hospital
🇺🇸York, Pennsylvania, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
Bethesda Memorial Hospital
🇺🇸Boynton Beach, Florida, United States
San Ramon Regional Medical Center
🇺🇸Walnut Creek, California, United States
Vascular Surgical Associates PC
🇺🇸Austell, Georgia, United States
Tallahassee Research Institute, Inc.
🇺🇸Tallahassee, Florida, United States
Peoria Radiology Research & Education Foundation
🇺🇸Peoria, Illinois, United States
MediQuest Research Group Inc at Munroe Regional Medical Center
🇺🇸Ocala, Florida, United States
St. John's Hospital, Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Michigan Vascular Research Center
🇺🇸Flint, Michigan, United States
Covenant Medical Center
🇺🇸Saginaw, Michigan, United States
Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
North Memorial Medical Center
🇺🇸Robbinsdale, Minnesota, United States
St. John's Regional Medical Center
🇺🇸Joplin, Missouri, United States
UMDNJ-Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Our Lady of Lourdes Medical Center
🇺🇸Cherry Hill, New Jersey, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
New Mexico Heart Institute, PA
🇺🇸Albuquerque, New Mexico, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Albany Medical Center Hospital
🇺🇸Albany, New York, United States
Overlook Hospital
🇺🇸Short Hills, New Jersey, United States
Kaleida Health
🇺🇸Buffalo, 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
Mercy Hospital of Buffalo
🇺🇸Buffalo, New York, United States
St. Joseph Hospital
🇺🇸Tacoma, Washington, United States
Grant Medical Center
🇺🇸Columbus, Ohio, United States
Southern Ohio Medical Center
🇺🇸Portsmouth, Ohio, United States
University of Toledo Medical Center
🇺🇸Toledo, Ohio, United States
Lake West Hospital
🇺🇸Willoughby, Ohio, United States
Mercy St. Vincent
🇺🇸Toledo, Ohio, United States
Pennsylvania Hospital of the University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Central PA Cardiovascular Research Institute
🇺🇸Harrisburg, 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
Sanford USD Medical Center - Sanford Clinical Research
🇺🇸Sioux Falls, South Dakota, United States
Erlanger Hospital
🇺🇸Chattanooga, Tennessee, United States
Baptist Hospital West
🇺🇸Knoxville, Tennessee, United States
Cardiovascular Associates PC
🇺🇸Kingsport, Tennessee, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Cardiothoracic and Vascular Surgeons (CTVS)
🇺🇸Austin, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
South Carolina Heart Center
🇺🇸Columbia, South Carolina, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
University of Arkansas
🇺🇸Little Rock, Arkansas, United States
Christiana Care Cardiovascular Research
🇺🇸Newark, Delaware, United States
St. Michael's Medical Center
🇺🇸Newark, New Jersey, United States
Memorial Hospital
🇺🇸Chattanooga, Tennessee, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
St. Joseph Medical Center
🇺🇸Kansas City, Missouri, United States
Norton Hospital
🇺🇸Louisville, Kentucky, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Baptist Memorial Hospital-Memphis
🇺🇸Memphis, Tennessee, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States