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

Primary Purpose

Carotid Stenosis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
NexStent Carotid Stent System (Monorail Delivery System)
FilterWire EZ™ Embolic Protection System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Stenosis focused on measuring NexStent, FilterWire EZ, Boston Scientific, Carotid Artery, Carotid Endarterectomy, Carotid Revascularization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Huntsville Hospital Heart Center
  • St. Luke's Medical Center
  • Central Cardiology Medical Clinic
  • Los Angeles Cardiology Associates
  • ACS Research Group, Inc.
  • Hoag Memorial Hospital / Presbyterian
  • Salinas Valley Memorial Healthcare System
  • University of Connecticut Health Center
  • JFK Medical Center
  • Northwest Medical Center
  • Baptist Cardiac and Vascular Institute, Baptist Hospital of Miami
  • Tampa General Hospital
  • Piedmont Hospital
  • Neurological Institute of Savannah
  • Advocate Christ Medical Center
  • Prairie Education & Research Cooperative
  • Northern Indiana Research Alliance
  • The Indiana Heart Hospital
  • Terrebonne General Medical Center
  • Ochsner Clinic Foundation
  • Willis Knighton Medical Center
  • Washington Adventist Hospital
  • Beth Israel Deaconess Medical Center
  • Caritas St. Elizabeth's Medical Center
  • William Beaumont Hospital
  • Providence Hospital
  • Great Lakes Heart & Vascular Institute
  • Michigan Heart PC
  • St. Luke's Hospital
  • Washington University in St. Louis
  • St. Anthony's Medical Center
  • Our Lady of Lourdes Medical Center
  • Hackensack University Medical Center
  • Morristown Memorial
  • New Mexico Heart Institute, PA
  • Albany Medical Center Hospital
  • Kaleida Health
  • Lenox Hill Hospital
  • Columbia University Medical Center
  • Buffalo Neurosurgery Group
  • Cleveland Clinic and Foundation
  • Ohio State University Medical
  • Riverside Methodist Hospital
  • Oklahoma Heart
  • Heritage Valley Health System
  • Geisinger Clinic
  • Center PA Cardiovascular Research Institute
  • University of Pennsylvania Medical Center
  • Hahnemann University Hospital
  • St. Mary Medical Center
  • York Hospital
  • South Carolina Heart Center
  • Erlanger Medical Center
  • Cardiovascular Associates, PC Wellmont Holston Valley Medical Center
  • University of Tennessee Medical Center
  • Dallas Fort Worth Vascular
  • Presbyterian Hospital of Dallas
  • Heart Center of North Texas
  • St. Luke's Episcopal Hospital
  • Central Cardiovaascular Research Foundation
  • Washington Cardiovscular Research and Education Foundation
  • St. Joseph Regional Medical Center

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2007
Last Updated
July 2, 2012
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00478673
Brief Title
Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA
Acronym
SONOMA
Official Title
The NexStent® Carotid Stent System: A Post Market Approval Evaluation Study In Conjunction With the FilterWire EZ™ Embolic Protection System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Enrollment was terminated in June 2008 due to market withdrawal of the NexStent Carotid Stent System.
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis
Keywords
NexStent, FilterWire EZ, Boston Scientific, Carotid Artery, Carotid Endarterectomy, Carotid Revascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
298 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
NexStent Carotid Stent System (Monorail Delivery System)
Intervention Description
Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
Intervention Type
Device
Intervention Name(s)
FilterWire EZ™ Embolic Protection System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)
Description
30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Time Frame
30 Days
Title
Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE)
Description
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.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subbarao Myla, M.D.
Organizational Affiliation
Hoag Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pamela Grady, PhD
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Huntsville Hospital Heart Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
St. Luke's Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Central Cardiology Medical Clinic
City
Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States
Facility Name
Los Angeles Cardiology Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
ACS Research Group, Inc.
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Hoag Memorial Hospital / Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Salinas Valley Memorial Healthcare System
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1705
Country
United States
Facility Name
JFK Medical Center
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Northwest Medical Center
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Baptist Cardiac and Vascular Institute, Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Neurological Institute of Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Prairie Education & Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Northern Indiana Research Alliance
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
The Indiana Heart Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Terrebonne General Medical Center
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Willis Knighton Medical Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Caritas St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Great Lakes Heart & Vascular Institute
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Michigan Heart PC
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University in St. Louis
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Anthony's Medical Center
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Our Lady of Lourdes Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Morristown Memorial
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
New Mexico Heart Institute, PA
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Albany Medical Center Hospital
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Kaleida Health
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Buffalo Neurosurgery Group
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Cleveland Clinic and Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Medical
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Oklahoma Heart
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Heritage Valley Health System
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Geisinger Clinic
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Center PA Cardiovascular Research Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Hahnemann University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
St. Mary Medical Center
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
Facility Name
South Carolina Heart Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Erlanger Medical Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Cardiovascular Associates, PC Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Dallas Fort Worth Vascular
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Presbyterian Hospital of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Heart Center of North Texas
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Central Cardiovaascular Research Foundation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Washington Cardiovscular Research and Education Foundation
City
Seattle
State/Province
Washington
ZIP/Postal Code
98121
Country
United States
Facility Name
St. Joseph Regional Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12924698
Citation
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.
Results Reference
background

Learn more about this trial

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

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