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

PHASE4TerminatedINTERVENTIONAL
Enrollment

298

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

July 31, 2009

Study Completion Date

July 31, 2009

Conditions
Carotid Stenosis
Interventions
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.

DEVICE

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.

Trial Locations (62)

10021

Lenox Hill Hospital, New York

10032

Columbia University Medical Center, New York

12208

Albany Medical Center Hospital, Albany

14209

Kaleida Health, Buffalo

14221

Buffalo Neurosurgery Group, Williamsville

15009

Heritage Valley Health System, Beaver

17110

Center PA Cardiovascular Research Institute, Harrisburg

17405

York Hospital, York

17822

Geisinger Clinic, Danville

19047

St. Mary Medical Center, Yardley

19104

University of Pennsylvania Medical Center, Philadelphia

19107

Hahnemann University Hospital, Philadelphia

20912

Washington Adventist Hospital, Takoma Park

29204

South Carolina Heart Center, Columbia

30309

Piedmont Hospital, Atlanta

31405

Neurological Institute of Savannah, Savannah

33063

Northwest Medical Center, Margate

33176

Baptist Cardiac and Vascular Institute, Baptist Hospital of Miami, Miami

33462

JFK Medical Center, Atlantis

33612

Tampa General Hospital, Tampa

35801

Huntsville Hospital Heart Center, Huntsville

37403

Erlanger Medical Center, Chattanooga

37660

Cardiovascular Associates, PC Wellmont Holston Valley Medical Center, Kingsport

37920

University of Tennessee Medical Center, Knoxville

43210

Ohio State University Medical, Columbus

43214

Riverside Methodist Hospital, Columbus

44195

Cleveland Clinic and Foundation, Cleveland

46256

The Indiana Heart Hospital, Indianapolis

46804

Northern Indiana Research Alliance, Fort Wayne

48073

William Beaumont Hospital, Royal Oak

48075

Providence Hospital, Southfield

48197

Michigan Heart PC, Ypsilanti

49085

Great Lakes Heart & Vascular Institute, Saint Joseph

53210

St. Joseph Regional Medical Center, Milwaukee

60453

Advocate Christ Medical Center, Oak Lawn

62701

Prairie Education & Research Cooperative, Springfield

63110

Washington University in St. Louis, St Louis

63128

St. Anthony's Medical Center, St Louis

64111

St. Luke's Hospital, Kansas City

70121

Ochsner Clinic Foundation, New Orleans

70360

Terrebonne General Medical Center, Houma

71103

Willis Knighton Medical Center, Shreveport

73120

Oklahoma Heart, Oklahoma City

75208

Dallas Fort Worth Vascular, Dallas

75231

Presbyterian Hospital of Dallas, Dallas

76104

Heart Center of North Texas, Fort Worth

77030

St. Luke's Episcopal Hospital, Houston

78201

Central Cardiovaascular Research Foundation, San Antonio

85006

St. Luke's Medical Center, Phoenix

87102

New Mexico Heart Institute, PA, Albuquerque

90017

Los Angeles Cardiology Associates, Los Angeles

92663

Hoag Memorial Hospital / Presbyterian, Newport Beach

93308

Central Cardiology Medical Clinic, Bakersfield

93901

Salinas Valley Memorial Healthcare System, Salinas

94040

ACS Research Group, Inc., Mountain View

98121

Washington Cardiovscular Research and Education Foundation, Seattle

06030-1705

University of Connecticut Health Center, Farmington

02215

Beth Israel Deaconess Medical Center, Boston

02135

Caritas St. Elizabeth's Medical Center, Brighton

08103

Our Lady of Lourdes Medical Center, Camden

07601

Hackensack University Medical Center, Hackensack

07960

Morristown Memorial, Morristown

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY