Study Stopped
Enrollment was terminated in June 2008 due to market withdrawal of the NexStent Carotid Stent System.
Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA
SONOMA
The NexStent® Carotid Stent System: A Post Market Approval Evaluation Study In Conjunction With the FilterWire EZ™ Embolic Protection System
2 other identifiers
interventional
298
1 country
62
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2007
Typical duration for phase_4
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 24, 2007
CompletedFirst Posted
Study publicly available on registry
May 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
August 7, 2012
CompletedAugust 7, 2012
July 1, 2012
2.2 years
May 24, 2007
December 20, 2010
July 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)
30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
30 Days
Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE)
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.
12 Months
Interventions
Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
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
You may qualify if:
- Candidates must be indicated for carotid stent placement as per NexStent Carotid Stent labeling located in the Directions for Use (DFU).
You may not qualify if:
- Subjects with contraindications as outlined in the DFU should be excluded from this registry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Huntsville Hospital Heart Center
Huntsville, Alabama, 35801, United States
St. Luke's Medical Center
Phoenix, Arizona, 85006, United States
Central Cardiology Medical Clinic
Bakersfield, California, 93308, United States
Los Angeles Cardiology Associates
Los Angeles, California, 90017, United States
ACS Research Group, Inc.
Mountain View, California, 94040, United States
Hoag Memorial Hospital / Presbyterian
Newport Beach, California, 92663, United States
Salinas Valley Memorial Healthcare System
Salinas, California, 93901, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030-1705, United States
JFK Medical Center
Atlantis, Florida, 33462, United States
Northwest Medical Center
Margate, Florida, 33063, United States
Baptist Cardiac and Vascular Institute, Baptist Hospital of Miami
Miami, Florida, 33176, United States
Tampa General Hospital
Tampa, Florida, 33612, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Neurological Institute of Savannah
Savannah, Georgia, 31405, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Prairie Education & Research Cooperative
Springfield, Illinois, 62701, United States
Northern Indiana Research Alliance
Fort Wayne, Indiana, 46804, United States
The Indiana Heart Hospital
Indianapolis, Indiana, 46256, United States
Terrebonne General Medical Center
Houma, Louisiana, 70360, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Willis Knighton Medical Center
Shreveport, Louisiana, 71103, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Caritas St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Great Lakes Heart & Vascular Institute
Saint Joseph, Michigan, 49085, United States
Providence Hospital
Southfield, Michigan, 48075, United States
Michigan Heart PC
Ypsilanti, Michigan, 48197, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
St. Anthony's Medical Center
St Louis, Missouri, 63128, United States
Our Lady of Lourdes Medical Center
Camden, New Jersey, 08103, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Morristown Memorial
Morristown, New Jersey, 07960, United States
New Mexico Heart Institute, PA
Albuquerque, New Mexico, 87102, United States
Albany Medical Center Hospital
Albany, New York, 12208, United States
Kaleida Health
Buffalo, New York, 14209, United States
Lenox Hill Hospital
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
Buffalo Neurosurgery Group
Williamsville, New York, 14221, United States
Cleveland Clinic and Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Medical
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Oklahoma Heart
Oklahoma City, Oklahoma, 73120, United States
Heritage Valley Health System
Beaver, Pennsylvania, 15009, United States
Geisinger Clinic
Danville, Pennsylvania, 17822, United States
Center PA Cardiovascular Research Institute
Harrisburg, Pennsylvania, 17110, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19107, United States
St. Mary Medical Center
Yardley, Pennsylvania, 19047, United States
York Hospital
York, Pennsylvania, 17405, United States
South Carolina Heart Center
Columbia, South Carolina, 29204, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
Cardiovascular Associates, PC Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Dallas Fort Worth Vascular
Dallas, Texas, 75208, United States
Presbyterian Hospital of Dallas
Dallas, Texas, 75231, United States
Heart Center of North Texas
Fort Worth, Texas, 76104, United States
St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
Central Cardiovaascular Research Foundation
San Antonio, Texas, 78201, United States
Washington Cardiovscular Research and Education Foundation
Seattle, Washington, 98121, United States
St. Joseph Regional Medical Center
Milwaukee, Wisconsin, 53210, United States
Related Publications (1)
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.
PMID: 12924698BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Enrollment was terminated in June 2008 due to market withdrawal of the NexStent Carotid Stent System. The early termination of enrollment led to a smaller than expected number of analyzable subjects (298 actual vs. 1500 anticipated).
Results Point of Contact
- Title
- Jim Taufen, Regulatory Affairs Manager
- Organization
- Boston Scientific Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Subbarao Myla, M.D.
Hoag Memorial Hospital
- STUDY DIRECTOR
Pamela Grady, PhD
Boston Scientific Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2007
First Posted
May 25, 2007
Study Start
May 1, 2007
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
August 7, 2012
Results First Posted
August 7, 2012
Record last verified: 2012-07