Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA (SONOMA)

July 2, 2012 updated by: Boston Scientific Corporation

The NexStent® Carotid Stent System: A Post Market Approval Evaluation Study In Conjunction With the FilterWire EZ™ Embolic Protection System

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The SONOMA Registry will enroll approximately 300 subjects at a maximum at 78 study centers.

Study Type

Interventional

Enrollment (Actual)

298

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Huntsville Hospital Heart Center
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • St. Luke's Medical Center
    • California
      • Bakersfield, California, United States, 93308
        • Central Cardiology Medical Clinic
      • Los Angeles, California, United States, 90017
        • Los Angeles Cardiology Associates
      • Mountain View, California, United States, 94040
        • ACS Research Group, Inc.
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital / Presbyterian
      • Salinas, California, United States, 93901
        • Salinas Valley Memorial Healthcare System
    • Connecticut
      • Farmington, Connecticut, United States, 06030-1705
        • University of Connecticut Health Center
    • Florida
      • Atlantis, Florida, United States, 33462
        • JFK Medical Center
      • Margate, Florida, United States, 33063
        • Northwest Medical Center
      • Miami, Florida, United States, 33176
        • Baptist Cardiac and Vascular Institute, Baptist Hospital of Miami
      • Tampa, Florida, United States, 33612
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Savannah, Georgia, United States, 31405
        • Neurological Institute of Savannah
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center
      • Springfield, Illinois, United States, 62701
        • Prairie Education & Research Cooperative
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Northern Indiana Research Alliance
      • Indianapolis, Indiana, United States, 46256
        • The Indiana Heart Hospital
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Terrebonne General Medical Center
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • Shreveport, Louisiana, United States, 71103
        • Willis Knighton Medical Center
    • Maryland
      • Takoma Park, Maryland, United States, 20912
        • Washington Adventist Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Brighton, Massachusetts, United States, 02135
        • Caritas St. Elizabeth's Medical Center
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
      • Southfield, Michigan, United States, 48075
        • Providence Hospital
      • St. Joseph, Michigan, United States, 49085
        • Great Lakes Heart & Vascular Institute
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart PC
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital
      • St Louis, Missouri, United States, 63110
        • Washington University in St. Louis
      • St Louis, Missouri, United States, 63128
        • St. Anthony's Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Our Lady of Lourdes Medical Center
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Morristown, New Jersey, United States, 07960
        • Morristown Memorial
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • New Mexico Heart Institute, PA
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center Hospital
      • Buffalo, New York, United States, 14209
        • Kaleida Health
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10021
        • Lenox Hill Hospital
      • Williamsville, New York, United States, 14221
        • Buffalo Neurosurgery Group
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic and Foundation
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Heritage Valley Health System
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Clinic
      • Harrisburg, Pennsylvania, United States, 17110
        • Center PA Cardiovascular Research Institute
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Hahnemann University Hospital
      • Yardley, Pennsylvania, United States, 19047
        • St. Mary Medical Center
      • York, Pennsylvania, United States, 17405
        • York Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • South Carolina Heart Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Medical Center
      • Kingsport, Tennessee, United States, 37660
        • Cardiovascular Associates, PC Wellmont Holston Valley Medical Center
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Presbyterian Hospital of Dallas
      • Dallas, Texas, United States, 75208
        • Dallas Fort Worth Vascular
      • Fort Worth, Texas, United States, 76104
        • Heart Center of North Texas
      • Houston, Texas, United States, 77030
        • St. Luke's Episcopal Hospital
      • San Antonio, Texas, United States, 78201
        • Central Cardiovaascular Research Foundation
    • Washington
      • Seattle, Washington, United States, 98121
        • Washington Cardiovscular Research and Education Foundation
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53210
        • St. Joseph Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Candidates must be indicated for carotid stent placement as per NexStent Carotid Stent labeling located in the Directions for Use (DFU).

Exclusion Criteria:

  • Subjects with contraindications as outlined in the DFU should be excluded from this registry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)
Time Frame: 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.
30 Days
Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE)
Time Frame: 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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Subbarao Myla, M.D., Hoag Memorial Hospital
  • Study Director: Pamela Grady, PhD, Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

May 24, 2007

First Submitted That Met QC Criteria

May 24, 2007

First Posted (Estimate)

May 25, 2007

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

July 2, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2042
  • SONOMA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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