Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)
- Conditions
- Carotid Artery Disease
- Registration Number
- NCT00402740
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of the Xact™ Rapid Exchange Carotid Stent System used in conjunction with the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5) and the Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3), in the treatment of atherosclerotic carotid artery disease in high-surgical risk subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 322
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years. 3 years Freedom from DSMI to 30 days or ipsilateral stroke from 31 days to 3 years. KM event free (%) curve.
- Secondary Outcome Measures
Name Time Method Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years. 3 years Acute Device Success Post-procedure Defined by the attainment of \<50% residual stenosis covering an area no longer than the original lesion treated with the stent.
Procedural Success 30 Days Defined as the attainment of less than 50% residual stenosis (per angiographic core lab) of the target lesion and the absence of DSMI at 30 days post-index procedure.
Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax ≤30 days Includes only each subject's first occurrence of each event.
Trial Locations
- Locations (38)
St. Michael's Medical Center
🇺🇸Newark, New Jersey, United States
Pinnacle Health Hospital
🇺🇸Harrisburg, Pennsylvania, United States
Bon Secours St. Mary's Hospital
🇺🇸Richmond, Virginia, United States
St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
Northwestern University Memorial Hospital
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Hawaii Permanente Medical Group-Kaiser Foundation Hospital
🇺🇸Honolulu, Hawaii, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
El Camino Hospital
🇺🇸Mountain View, California, United States
Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
Memorial Hospital Jacksonville
🇺🇸Jacksonville, Florida, United States
Munroe Regional Medical Center
🇺🇸Ocala, Florida, United States
St. John's Hospital / Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Parkview Hospital
🇺🇸Fort Wayne, Indiana, United States
St. Vincent Hospital and Health Care Center
🇺🇸Indianapolis, Indiana, United States
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States
Terrebonne General Medical Center
🇺🇸Houma, Louisiana, United States
St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
McLaren Regional Medical Center
🇺🇸Flint, Michigan, United States
Our Lady of Lourdes Medical Center
🇺🇸Camden, New Jersey, United States
Millard Fillmore Hospital-Kaleida Health Systems
🇺🇸Buffalo, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
WakeMed Hospital
🇺🇸Raleigh, North Carolina, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
St. Joseph's Medical center
🇺🇸Wyomissing, Pennsylvania, United States
Austin Heart P.A.
🇺🇸Austin, Texas, United States
Mercy Medical Center West / Baptist Hospital of East Tennessee
🇺🇸Knoxville, Tennessee, United States
Presbyterian Heart Institute
🇺🇸Dallas, Texas, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Chesapeake General Hospital
🇺🇸Norfolk, Virginia, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Greenville Memorial Medical Center
🇺🇸Greenville, South Carolina, United States
Washington Hospital
🇺🇸Fremont, California, United States