322
Participants
Start Date
November 30, 2006
Primary Completion Date
June 30, 2011
Study Completion Date
October 31, 2011
Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)
All subjects will receive the Xact™ Rapid Exchange Carotid Stent System. The first 220 consecutively enrolled subjects will be treated with the investigational filter system, the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5). The remaining subjects will be treated with the FDA approved Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3).
Lenox Hill Hospital, New York
Millard Fillmore Hospital-Kaleida Health Systems, Buffalo
Pinnacle Health Hospital, Harrisburg
Lehigh Valley Hospital, Allentown
St. Joseph's Medical center, Wyomissing
Washington Adventist Hospital, Takoma Park
Bon Secours St. Mary's Hospital, Richmond
Chesapeake General Hospital, Norfolk
WakeMed Hospital, Raleigh
Greenville Memorial Medical Center, Greenville
Memorial Hospital Jacksonville, Jacksonville
Lakeland Regional Medical Center, Lakeland
Munroe Regional Medical Center, Ocala
Holston Valley Medical Center, Kingsport
Mercy Medical Center West / Baptist Hospital of East Tennessee, Knoxville
St. Vincent Hospital and Health Care Center, Indianapolis
Parkview Hospital, Fort Wayne
William Beaumont Hospital, Royal Oak
St. Joseph Mercy Hospital, Ann Arbor
Genesys Regional Medical Center, Grand Blanc
McLaren Regional Medical Center, Flint
St. Luke's Medical Center, Milwaukee
Northwestern University Memorial Hospital, Chicago
St. John's Hospital / Memorial Medical Center, Springfield
Terrebonne General Medical Center, Houma
Presbyterian Heart Institute, Dallas
St. Luke's Episcopal Hospital, Houston
Austin Heart P.A., Austin
Hoag Memorial Hospital Presbyterian, Newport Beach
El Camino Hospital, Mountain View
Stanford University Medical Center, Stanford
Washington Hospital, Fremont
Hawaii Permanente Medical Group-Kaiser Foundation Hospital, Honolulu
Oregon Health & Science University, Portland
University of Connecticut Health Center, Farmington
Massachusetts General Hospital, Boston
Our Lady of Lourdes Medical Center, Camden
St. Michael's Medical Center, Newark
Lead Sponsor
Abbott Medical Devices
INDUSTRY