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

Carotid Stenosis Clinical Trial

— SONOMA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00478673
• Other study ID #: S2042
• Secondary ID: SONOMA
• Status: Terminated
• Phase: Phase 4
• First received: May 24, 2007
• Last updated: July 2, 2012
• Start date: May 2007
• Est. completion date: July 2009

Study information

• Verified date: July 2012
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 298
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

Device:
• NexStent Carotid Stent System (Monorail Delivery System)
Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
• FilterWire EZ™ Embolic Protection System
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.

Locations

Country	Name	City	State
United States	Albany Medical Center Hospital	Albany	New York
United States	New Mexico Heart Institute, PA	Albuquerque	New Mexico
United States	Piedmont Hospital	Atlanta	Georgia
United States	JFK Medical Center	Atlantis	Florida
United States	Central Cardiology Medical Clinic	Bakersfield	California
United States	Heritage Valley Health System	Beaver	Pennsylvania
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Caritas St. Elizabeth's Medical Center	Brighton	Massachusetts
United States	Kaleida Health	Buffalo	New York
United States	Our Lady of Lourdes Medical Center	Camden	New Jersey
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	Cleveland Clinic and Foundation	Cleveland	Ohio
United States	South Carolina Heart Center	Columbia	South Carolina
United States	Ohio State University Medical	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Dallas Fort Worth Vascular	Dallas	Texas
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	Geisinger Clinic	Danville	Pennsylvania
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Northern Indiana Research Alliance	Fort Wayne	Indiana
United States	Heart Center of North Texas	Fort Worth	Texas
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Center PA Cardiovascular Research Institute	Harrisburg	Pennsylvania
United States	Terrebonne General Medical Center	Houma	Louisiana
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	Huntsville Hospital Heart Center	Huntsville	Alabama
United States	The Indiana Heart Hospital	Indianapolis	Indiana
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Cardiovascular Associates, PC Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Los Angeles Cardiology Associates	Los Angeles	California
United States	Northwest Medical Center	Margate	Florida
United States	Baptist Cardiac and Vascular Institute, Baptist Hospital of Miami	Miami	Florida
United States	St. Joseph Regional Medical Center	Milwaukee	Wisconsin
United States	Morristown Memorial	Morristown	New Jersey
United States	ACS Research Group, Inc.	Mountain View	California
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	Hoag Memorial Hospital / Presbyterian	Newport Beach	California
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Oklahoma Heart	Oklahoma City	Oklahoma
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	St. Luke's Medical Center	Phoenix	Arizona
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Salinas Valley Memorial Healthcare System	Salinas	California
United States	Central Cardiovaascular Research Foundation	San Antonio	Texas
United States	Neurological Institute of Savannah	Savannah	Georgia
United States	Washington Cardiovscular Research and Education Foundation	Seattle	Washington
United States	Willis Knighton Medical Center	Shreveport	Louisiana
United States	Providence Hospital	Southfield	Michigan
United States	Prairie Education & Research Cooperative	Springfield	Illinois
United States	St. Anthony's Medical Center	St Louis	Missouri
United States	Washington University in St. Louis	St Louis	Missouri
United States	Great Lakes Heart & Vascular Institute	St. Joseph	Michigan
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Tampa General Hospital	Tampa	Florida
United States	Buffalo Neurosurgery Group	Williamsville	New York
United States	St. Mary Medical Center	Yardley	Pennsylvania
United States	York Hospital	York	Pennsylvania
United States	Michigan Heart PC	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes