Clinical trial NCT00478673: Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Carotid Stenosis
Keywords: NexStent
FilterWire EZ
Boston Scientific
Carotid Artery
Carotid Endarterectomy
Carotid Revascularization
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2007-05-25
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)
timeFrame: 30 Days
measure: Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Huntsville Hospital Heart Center
state: Alabama
city: Phoenix
country: United States
facility: St. Luke's Medical Center
state: Arizona
city: Bakersfield
country: United States
facility: Central Cardiology Medical Clinic
state: California
city: Los Angeles
country: United States
facility: Los Angeles Cardiology Associates
state: California
city: Mountain View
country: United States
facility: ACS Research Group, Inc.
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital / Presbyterian
state: California
city: Salinas
country: United States
facility: Salinas Valley Memorial Healthcare System
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Margate
country: United States
facility: Northwest Medical Center
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute, Baptist Hospital of Miami
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Savannah
country: United States
facility: Neurological Institute of Savannah
state: Georgia
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative
state: Illinois
city: Fort Wayne
country: United States
facility: Northern Indiana Research Alliance
state: Indiana
city: Indianapolis
country: United States
facility: The Indiana Heart Hospital
state: Indiana
city: Houma
country: United States
facility: Terrebonne General Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Willis Knighton Medical Center
state: Louisiana
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Brighton
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: St. Joseph
country: United States
facility: Great Lakes Heart & Vascular Institute
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart PC
state: Michigan
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: St Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: St Louis
country: United States
facility: St. Anthony's Medical Center
state: Missouri
city: Camden
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute, PA
state: New Mexico
city: Albany
country: United States
facility: Albany Medical Center Hospital
state: New York
city: Buffalo
country: United States
facility: Kaleida Health
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Williamsville
country: United States
facility: Buffalo Neurosurgery Group
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic and Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart
state: Oklahoma
city: Beaver
country: United States
facility: Heritage Valley Health System
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Harrisburg
country: United States
facility: Center PA Cardiovascular Research Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Yardley
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Heart Center
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Kingsport
country: United States
facility: Cardiovascular Associates, PC Wellmont Holston Valley Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Dallas Fort Worth Vascular
state: Texas
city: Dallas
country: United States
facility: Presbyterian Hospital of Dallas
state: Texas
city: Fort Worth
country: United States
facility: Heart Center of North Texas
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: San Antonio
country: United States
facility: Central Cardiovaascular Research Foundation
state: Texas
city: Seattle
country: United States
facility: Washington Cardiovscular Research and Education Foundation
state: Washington
city: Milwaukee
country: United States
facility: St. Joseph Regional Medical Center
state: Wisconsin
Study officials:
affiliation: Hoag Memorial Hospital
name: Subbarao Myla, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Scientific Corporation
name: Pamela Grady, PhD
role: STUDY_DIRECTOR
References:
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.