Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
- Conditions
- Carotid Stenosis
- Interventions
- Device: Carotid Stenting (CAS)Other: Intensive Medical Management - no CASProcedure: Carotid endarterectomy (CEA)Other: Intensive Medical Management - no CEA
- Registration Number
- NCT02089217
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.
- Detailed Description
Prevention of stroke involves managing and treating risk factors. Most strokes are caused when blood flow to a portion of the brain is blocked. One place this often happens is in the carotid artery. This blockage is called atherosclerosis or hardening of the arteries.
The purpose of this trial is to determine the best way to prevent strokes in people who have a high amount of blockage of their carotid artery but no stroke symptoms related to that blockage. Each eligible participant will be evaluated to determine which procedure(s) is best for him/her. All participants will receive intensive medical treatment. In addition, participants will be randomized to receive the selected procedure or not.
The trial will be conducted in the United States and Canada by physicians carefully selected on their ability to perform the procedures at low risk. Another key component of the trial is that important stroke risk factors, including hypertension, diabetes, high cholesterol, cigarette smoking, physical activity, and diet will be managed intensively. Participants will remain in the study for 4 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2486
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carotid Stenting (CAS) Carotid Stenting (CAS) Carotid Stenting Intensive Medical Management - no CAS Intensive Medical Management - no CAS Intensive Medical Management alone - no CAS Carotid Endarterectomy (CEA) Carotid endarterectomy (CEA) Carotid Endarterectomy Intensive Medical Management - no CEA Intensive Medical Management - no CEA Intensive Medical Management alone - no CEA
- Primary Outcome Measures
Name Time Method Stroke and death 4 years The primary outcome is the composite of stroke plus death within 44 days after randomization and ipsilateral stroke thereafter up to 4 years.
- Secondary Outcome Measures
Name Time Method Cognitive Function 4 years The assess if MEDICAL management differs from CAS, and differs from CEA, to maintain the level of cognitive function at the 4-year assessment.
Major Stroke 4 years if there are treatment differences in the incidence of major stroke at 4-years among all arms of the study
Effect modification 4 years Potential effect modification of the CAS or CEA versus MEDICAL differences, based on patient age, sex, severity of carotid stenosis, restenosis, risk factor level, and duration of asymptomatic period.
Trial Locations
- Locations (167)
UPMC Presbyterian University Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
VA Pittsburgh Healthcare
🇺🇸Pittsburgh, Pennsylvania, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
University of Miami Hospital
🇺🇸Miami, Florida, United States
Miami Cardiac and Vascular Institute at Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
University of California Irvine
🇺🇸Irvine, California, United States
Mission Cardiovascular Research Institute
🇺🇸Fremont, California, United States
St. Joseph's Medical Center
🇺🇸Stockton, California, United States
Southern Illinois Healthcare
🇺🇸Carbondale, Illinois, United States
University of California Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
Northshore University
🇺🇸Evanston, Illinois, United States
UC San Diego Health
🇺🇸La Jolla, California, United States
Central Arkansas Veteran's Healthcare System
🇺🇸Little Rock, Arkansas, United States
Keck Medical Center of University of Southern California
🇺🇸Los Angeles, California, United States
Kaiser Permanente
🇺🇸San Diego, California, United States
Huntsville Hospital/ Heart Center Research Alabama
🇺🇸Huntsville, Alabama, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Mount Sinai Hospital New York
🇺🇸New York, New York, United States
Crouse Hospital
🇺🇸Syracuse, New York, United States
Beth Israel Deaconess Medical Center (BIDMC)
🇺🇸Boston, Massachusetts, United States
Mercy Hospital
🇺🇸Saint Louis, Missouri, United States
Shaare-Zedek Medical Center
🇮🇱Jerusalem, Israel
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Lehigh Valley Hospital - Network Office of Research
🇺🇸Allentown, Pennsylvania, United States
Ohio State Medical Center
🇺🇸Columbia, Ohio, United States
Jobst Vascular Institute/University of Toledo
🇺🇸Toledo, Ohio, United States
Mercy Health St.Vincent Medical Center
🇺🇸Toledo, Ohio, United States
Valley Baptist Medical Center
🇺🇸Harlingen, Texas, United States
Louis Stokes Cleveland VA Medical Center
🇺🇸Cleveland, Ohio, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
North Carolina Heart & Vascular Research
🇺🇸Raleigh, North Carolina, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
🇺🇸Wormleysburg, Pennsylvania, United States
Inova Fairfax Health Care
🇺🇸Falls Church, Virginia, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Winchester Medical Center
🇺🇸Winchester, Virginia, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Memorial Hermann Texas Medical Center
🇺🇸Houston, Texas, United States
Fiona Stanley Hospital
🇦🇺Perth, Australia
Hospital Clinic Barcelona
🇪🇸Barcelona, Spain
University of Washington Medicine-Harborview Medical Center
🇺🇸Seattle, Washington, United States
VA Puget Sound Health Care System
🇺🇸Seattle, Washington, United States
Providence Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Kaiser Permanente Los Angeles
🇺🇸Los Angeles, California, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Providence Little Company of Mary Medical Center
🇺🇸Torrance, California, United States
Atlanta VA Medical Center
🇺🇸Atlanta, Georgia, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Prairie Heart/St. John's Hospital
🇺🇸Springfield, Illinois, United States
Mercy Health Riverside
🇺🇸Rockford, Illinois, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Franciscan St. Francis Health
🇺🇸Indianapolis, Indiana, United States
Deaconess Heart Group
🇺🇸Newburgh, Indiana, United States
John Cochran VA Medical Center
🇺🇸Saint Louis, Missouri, United States
Cox Medical Center
🇺🇸Springfield, Missouri, United States
Mercy Medical Research Institute
🇺🇸Springfield, Missouri, United States
The Feinstein Institute of Medical Research/Northwell Health
🇺🇸Manhasset, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Stony Brook University
🇺🇸Stony Brook, New York, United States
UPMC Altoona
🇺🇸Altoona, Pennsylvania, United States
UPMC Hamot
🇺🇸Erie, Pennsylvania, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Kaiser Permanente Northern California
🇺🇸San Francisco, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
San Francisco VA Medical Center
🇺🇸San Francisco, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Minneapolis Clinic of Neurology, Ltd./North Memorial Medical Center
🇺🇸Golden Valley, Minnesota, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Sanford Health
🇺🇸Fargo, North Dakota, United States
St. Cloud Hospital
🇺🇸Saint Cloud, Minnesota, United States
Medical Center of the Rockies
🇺🇸Loveland, Colorado, United States
St. Mary's Hospital Regional Medical Center
🇺🇸Grand Junction, Colorado, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Cardiovascular Associates/Brookwood Medical Center
🇺🇸Birmingham, Alabama, United States
Abrazo Arizona Heart Hospital
🇺🇸Phoenix, Arizona, United States
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of California San Diego
🇺🇸San Diego, California, United States
Medstar/Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
St. Joseph's Hospital and Medical Center/Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
HonorHealth Scottsdale Osborn Medical Center
🇺🇸Scottsdale, Arizona, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Banner University Medical Center
🇺🇸Tucson, Arizona, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Lyerly Neurosurgery
🇺🇸Jacksonville, Florida, United States
University of Massachusetts Memorial Hospital
🇺🇸Worcester, Massachusetts, United States
First Coast Cardiovascular Institute
🇺🇸Jacksonville, Florida, United States
University of Utah Hospitals and Clinics
🇺🇸Salt Lake City, Utah, United States
North Central Heart Institute
🇺🇸Sioux Falls, South Dakota, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Tennova Healthcare/ Turkey Creek Medical Center
🇺🇸Knoxville, Tennessee, United States
Cardiovascular Institute of Northwest Florida
🇺🇸Panama City, Florida, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Soroka University Medical Center
🇮🇱Be'er Sheva, Israel
George E. Wahlen Department of Veterans Affairs Medical Center
🇺🇸Salt Lake City, Utah, United States
Rambam Healthcare
🇮🇱Haifa, Israel
UF Jacksonville
🇺🇸Jacksonville, Florida, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Mount Sinai Medical Center of Florida
🇺🇸Miami Beach, Florida, United States
CHU de Québec/ Hôpital de l'Enfant-Jésus
🇨🇦Québec City, Quebec, Canada
Soroka University Vascular Surgery
🇮🇱Be'er Sheva, Israel
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Nova Scotia Health Authority
🇨🇦Halifax, Nova Scotia, Canada
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
Tallahassee Neurological Clinic
🇺🇸Tallahassee, Florida, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
University of Maryland VA
🇺🇸Baltimore, Maryland, United States
John Hopkins Medical Institution
🇺🇸Baltimore, Maryland, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Cardiac and Vascular Research Center of Northern Michigan/McLaren Northern Michigan
🇺🇸Petoskey, Michigan, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Trinity Health/Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
St. Elizabeth's Medical Center
🇺🇸Boston, Massachusetts, United States
Gundersen Clinic, Ltd
🇺🇸La Crosse, Wisconsin, United States
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Michigan Vascular Center/McLaren- Flint
🇺🇸Flint, Michigan, United States
Cooper University
🇺🇸Camden, New Jersey, United States
St. Boniface Hospital
🇨🇦Winnipeg, Ontario, Canada
Providence Brain and Spine Institute
🇺🇸Portland, Oregon, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Tampa General/University of South Florida
🇺🇸Tampa, Florida, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
VA Ann Arbor Healthcare System
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Hospital and Health Systems
🇺🇸Ann Arbor, Michigan, United States
Novant Health/Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Mission Cardiovascular Research
🇺🇸Fremont, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
SUNY Buffalo
🇺🇸Buffalo, New York, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Coastal Carolina Surgical Associates PA
🇺🇸Wilmington, North Carolina, United States
St. John Clinical Research Institute
🇺🇸Tulsa, Oklahoma, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Berks Cardiologists / St. Joseph's Medical Center
🇺🇸Wyomissing, Pennsylvania, United States
CVA Heart Institute
🇺🇸Kingsport, Tennessee, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Overlake Hospital
🇺🇸Bellevue, Washington, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States
Ochsner Health System
🇺🇸New Orleans, Louisiana, United States
Tulane University Heart and Vascular
🇺🇸New Orleans, Louisiana, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Seton Medical Center Austin
🇺🇸Austin, Texas, United States
Cardiothoracic and Vascular Surgeons
🇺🇸Austin, Texas, United States
University of Florida Health at Shands
🇺🇸Gainesville, Florida, United States
White Oak Medical Center
🇺🇸Takoma Park, Maryland, United States
University of Wisconsin Hospitals & Clinics
🇺🇸Madison, Wisconsin, United States
University of Kentucky Hospital
🇺🇸Lexington, Kentucky, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States