A Carotid Stenting Boston Scientific Surveillance Program

PHASE4CompletedINTERVENTIONAL
Enrollment

1,097

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

October 31, 2010

Study Completion Date

October 31, 2010

Conditions
Carotid Artery Disease
Interventions
DEVICE

Carotid WALLSTENT Monorail Endoprosthesis

A carotid artery stent for use in subjects at high risk for adverse events from Carotid endarterectomy (CEA) due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.

DEVICE

FilterWire EZ™ System™

Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.

Trial Locations (112)

10029

Mount Sinai Medical Center, New York

11219

Maimonides Medical Center, Brooklyn

11794

Stony Brook University Medical Center, Stony Brook

12208

Albany Medical Center Hospital, Albany

13088

St. Joseph Hospital, Liverpool

14209

Kaleida Health, Buffalo

14221

Mercy Hospital of Buffalo, Buffalo

17043

Pinnacle Health at Harrisburg Hospital, Wormleysburg

17110

Central PA Cardiovascular Research Institute, Harrisburg

17403

York Hospital, York

18105

Lehigh Valley Hospital, Allentown

19067

St. Mary Medical Center, Yardley

19106

Pennsylvania Hospital of the University of Pennsylvania Health System, Philadelphia

19610

Berks Cardiologists, Ltd., Wyomissing

19718

Christiana Care Cardiovascular Research, Newark

20735

Southern Maryland Hospital Center, Clinton

22042

Inova Fairfax Hospital, Falls Church

23507

Sentara Norfolk General Hospital, Norfolk

27103

Forsyth Medical Center, Winston-Salem

27610

Wake Medical Center, Raleigh

29204

South Carolina Heart Center, Columbia

29425

Medical University of South Carolina, Charleston

29605

University Medical Center - Greenville Memorial Hospital, Greenville

30106

Vascular Surgical Associates PC, Austell

30308

Emory University Hospital, Atlanta

30309

Piedmont Hospital, Atlanta

30342

St. Joseph's Research Institute, Atlanta

32308

Tallahassee Research Institute, Inc., Tallahassee

32611

University of Florida, Gainesville

33021

Aventura Hospital, Hollywood

33136

University of Miami Hospital, Miami

33176

Baptist Hospital of Miami, Miami

33308

Jim Moran Heart and Vascular Research Institute, Fort Lauderdale

33435

Bethesda Memorial Hospital, Boynton Beach

33462

JFK Medical Center, Atlantis

33487

Delray Medical Center, Boca Raton

34205

Bradenton Cardiology, Bradenton

34471

MediQuest Research Group Inc at Munroe Regional Medical Center, Ocala

35211

Baptist Medical Center Princeton, Birmingham

36532

Cardiology Associates of Mobile, Fairhope

37403

Erlanger Hospital, Chattanooga

37404

Memorial Hospital, Chattanooga

37660

Cardiovascular Associates PC, Kingsport

37920

University of Tennessee Medical Center, Knoxville

37934

Baptist Hospital West, Knoxville

38120

Baptist Memorial Hospital-Memphis, Memphis

40202

Norton Hospital, Louisville

43214

Riverside Methodist Hospital, Columbus

43215

Grant Medical Center, Columbus

43608

Mercy St. Vincent, Toledo

43614

University of Toledo Medical Center, Toledo

44094

Lake West Hospital, Willoughby

44195

Cleveland Clinic Foundation, Cleveland

45242

Bethesda North Hospital, Cincinnati

45662

Southern Ohio Medical Center, Portsmouth

46202

Indiana University School of Medicine, Indianapolis

46250

The Indiana Heart Hospital, Indianapolis

48109

University of Michigan, Ann Arbor

48507

Michigan Vascular Research Center, Flint

48602

Covenant Medical Center, Saginaw

49085

Great Lakes Heart and Vascular, Saint Joseph

49770

Northern Michigan Hospital, Petoskey

53233

Aurora St. Luke's Medical Center, Milwaukee

55422

North Memorial Medical Center, Robbinsdale

57105

Sanford USD Medical Center - Sanford Clinical Research, Sioux Falls

60453

Advocate Christ Medical Center, Oak Lawn

61637

Peoria Radiology Research & Education Foundation, Peoria

62701

St. John's Hospital, Prairie Education and Research Cooperative, Springfield

62702

Southern Illinois University - Memorial Medical Center, Springfield

64114

St. Joseph Medical Center, Kansas City

64804

Freeman Heart & Vascular Institute, Joplin

St. John's Regional Medical Center, Joplin

68131

The Cardiac Center of Creighton University, Omaha

70121

Ochsner Clinic Foundation, New Orleans

70570

Opelousas General Health Center, Opelousas

71201

Physicians and Surgeons Surgical Hospital, Monroe

72205

University of Arkansas, Little Rock

75024

The Heart Hospital Baylor Plano, Plano

75230

Medical City Dallas Hospital, Dallas

75231

Presbyterian Hospital of Dallas, Dallas

77030

St. Luke's Episcopal Hospital, Houston

The Methodist Hospital, Houston

77555

University of Texas Medical Branch, Galveston

78205

Peripheral Vascular Associates, San Antonio

78229

University of Texas Health Science Center San Antonio, San Antonio

78756

Cardiothoracic and Vascular Surgeons (CTVS), Austin

80045

University of Colorado Hospital, Aurora

82102

New Mexico Heart Institute, PA, Albuquerque

85013

St. Joseph's Hospital and Medical Center, Barrow Neurological Institute, Phoenix

85741

Southern Arizona Vascular Institute, Tucson

90017

Los Angeles Cardiology Associates, Los Angeles

90095

Ronald Reagan UCLA Medical Center, Los Angeles

92663

Hoag Hospital, Newport Beach

93308

Central Cardiology Medical Clinic, Bakersfield

93907

Salinas Valley Memorial Healthcare System, Salinas

94143

University of California, San Francisco, San Francisco

94304

VA Palo Alto Health Care System, Palo Alto

94598

San Ramon Regional Medical Center, Walnut Creek

95204

St. Joseph's Medical Center, Stockton

97239

Oregon Stroke Center, Portland

98122

Swedish Medical Center, Seattle

98405

St. Joseph Hospital, Tacoma

06030

University of Connecticut Health Center, Farmington

06708

Waterbury Hospital, Waterbury

02215

Beth Israel Deaconess Medical Center, Boston

03756

Dartmouth Hitchcock Medical Center, Lebanon

08103

Cooper University Hospital, Camden

08034

Our Lady of Lourdes Medical Center, Cherry Hill

08903

UMDNJ-Robert Wood Johnson Medical School, New Brunswick

07102

St. Michael's Medical Center, Newark

07078

Overlook Hospital, Short Hills

02905

Rhode Island Hospital, Providence

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY