Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™

PHASE3CompletedINTERVENTIONAL
Enrollment

488

Participants

Timeline

Start Date

December 31, 2001

Primary Completion Date

March 31, 2005

Study Completion Date

June 30, 2007

Conditions
Transient Ischemic AttackThromboembolic StrokeStroke Prevention
Interventions
DEVICE

EndoTex™ NexStent™

EndoTex™ NexStent™ is a flexible, fine mesh Nitinol stent used to treat patients that are at high risk of adverse events from carotid endarterectomy and require carotid revascularization of a target vessel that has a reference diameter between 4mm and 9mm and stenosis that is less than 30mm in length.

DEVICE

Filter Wire EZ™

EPI Fliter Wire EZ™ Embolic Protection System is indicated for use 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 (19)

1093

Favaloro Institute, Buenos Aires

10021

Columbia - Weill Cornell Division of Vascular Surgery, New York

Lenox Hill Hospital, New York

12208

Albany Medical College, Albany

14209

Millard Fillmore Gates Hospital, Buffalo

15212

Allegheny General Hospital, Pittsburgh

15232

University of Pittsburgh (UPMC-Shadyside), Pittsburgh

17101

Harrisburg Hospital, Harrisburg

21218

Union Memorial Hospital, Baltimore

28203

Carolina Medical Center, Charlotte

44195

Cleveland Clinic Foundation, Cleveland

53721

Sieburg Heart Center, Germany, Siegburg

60389

Cardiovascular Center Bethanien, Germany, Frankfurt

70121

Oschner Clinic Foundation, New Orleans

85013

St. Joseph's Hospital and Medical Center, Phoenix

92663

Hoag Hospital, Newport Beach

94040

El Camino Hospital, Mountain View

98104

Swedish Medical Center, Seattle

04289

Leipzig Heart Center, Leipzig

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY