Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA
- Conditions
- Carotid Stenosis
- Registration Number
- NCT00478673
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The primary objective of the SONOMA Registry is to confirm the safety of the NexStent® Carotid Stent System and FilterWire EZ™ Embolic Protection System in routine clinical practice and to identify rare or unanticipated device-related events that might occur.
- Detailed Description
The SONOMA Registry will enroll approximately 300 subjects at a maximum at 78 study centers.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 298
- Candidates must be indicated for carotid stent placement as per NexStent Carotid Stent labeling located in the Directions for Use (DFU).
- Subjects with contraindications as outlined in the DFU should be excluded from this registry.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE) 30 Days 30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE) 12 Months 12-month major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure (see 30-Day MAE above), and ipsilateral stroke events that occur within 31-365 days post-procedure.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (62)
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
York Hospital
🇺🇸York, Pennsylvania, United States
Cleveland Clinic and Foundation
🇺🇸Cleveland, Ohio, United States
St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
Central Cardiovaascular Research Foundation
🇺🇸San Antonio, Texas, United States
Oklahoma Heart
🇺🇸Oklahoma City, Oklahoma, United States
Hoag Memorial Hospital / Presbyterian
🇺🇸Newport Beach, California, United States
Los Angeles Cardiology Associates
🇺🇸Los Angeles, California, United States
Huntsville Hospital Heart Center
🇺🇸Huntsville, Alabama, United States
Central Cardiology Medical Clinic
🇺🇸Bakersfield, California, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Baptist Cardiac and Vascular Institute, Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
St. Luke's Medical Center
🇺🇸Phoenix, Arizona, United States
St. Anthony's Medical Center
🇺🇸St Louis, Missouri, United States
ACS Research Group, Inc.
🇺🇸Mountain View, California, United States
Salinas Valley Memorial Healthcare System
🇺🇸Salinas, California, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
JFK Medical Center
🇺🇸Atlantis, Florida, United States
Neurological Institute of Savannah
🇺🇸Savannah, Georgia, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Northern Indiana Research Alliance
🇺🇸Fort Wayne, Indiana, United States
The Indiana Heart Hospital
🇺🇸Indianapolis, Indiana, United States
Prairie Education & Research Cooperative
🇺🇸Springfield, Illinois, United States
Willis Knighton Medical Center
🇺🇸Shreveport, Louisiana, United States
Terrebonne General Medical Center
🇺🇸Houma, Louisiana, United States
Great Lakes Heart & Vascular Institute
🇺🇸St. Joseph, Michigan, United States
Michigan Heart PC
🇺🇸Ypsilanti, Michigan, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Our Lady of Lourdes Medical Center
🇺🇸Camden, New Jersey, United States
Morristown Memorial
🇺🇸Morristown, New Jersey, United States
Ohio State University Medical
🇺🇸Columbus, Ohio, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Kaleida Health
🇺🇸Buffalo, New York, United States
Albany Medical Center Hospital
🇺🇸Albany, New York, United States
Buffalo Neurosurgery Group
🇺🇸Williamsville, New York, United States
Washington Cardiovscular Research and Education Foundation
🇺🇸Seattle, Washington, United States
Heritage Valley Health System
🇺🇸Beaver, Pennsylvania, United States
St. Mary Medical Center
🇺🇸Yardley, Pennsylvania, United States
Erlanger Medical Center
🇺🇸Chattanooga, Tennessee, United States
Dallas Fort Worth Vascular
🇺🇸Dallas, Texas, United States
South Carolina Heart Center
🇺🇸Columbia, South Carolina, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Cardiovascular Associates, PC Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Presbyterian Hospital of Dallas
🇺🇸Dallas, Texas, United States
Heart Center of North Texas
🇺🇸Fort Worth, Texas, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
St. Joseph Regional Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Northwest Medical Center
🇺🇸Margate, Florida, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Caritas St. Elizabeth's Medical Center
🇺🇸Brighton, Massachusetts, United States
Providence Hospital
🇺🇸Southfield, Michigan, United States
Washington University in St. Louis
🇺🇸St Louis, Missouri, United States
New Mexico Heart Institute, PA
🇺🇸Albuquerque, New Mexico, United States
Geisinger Clinic
🇺🇸Danville, Pennsylvania, United States
University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Center PA Cardiovascular Research Institute
🇺🇸Harrisburg, Pennsylvania, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States