NCT05465122|Active Not Recruiting
CREST-2 Long-term Observational Extension Study
C2LOE
Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial
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C2LOE
Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial
Sponsor study identifier
Secondary identifiers
observational
2,480
3 countries
64
Study Start
July 5, 2022
Actual (reported)Primary Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of this Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial (C2LOE - ClinicalTrials.gov Identifier: NCT02089217) study is to study is to assess post-procedural efficacy of carotid endarterectomy and carotid stenting.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 30, 2022
Actual (reported)July 5, 2022
Actual (reported)July 19, 2022
Actual (reported)August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Stroke
Number of participants to experience a stroke
5 years
Subjects assigned to the intensive medical management with carotid stenting group in the CREST-2 study (NCT02089217)
Subjects assigned to the intensive medical management with carotid endarterectomy group in the CREST-2 study (NCT02089217)
Subjects assigned to the intensive medical management alone with no carotid stenting (CAS) group in the CREST-2 study (NCT02089217)
Subjects assigned to the intensive medical management alone with no carotid endarterectomy (CEA) group in the CREST-2 study (NCT02089217)
This is the standard proven therapy for carotid stenosis that involves an arteriotomy followed by removal of plaque and reconstruction of the vessel.
This is the standard proven therapy for carotid stenosis that involves an arteriotomy followed by removal of plaque and reconstruction of the vessel.
Patients with asymptomatic carotid stenosis previously randomized in the CREST-2 trial.
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Mayo Clinic Pheonix
Phoenix, Arizona, 85054, United States
Banner University Medical Center
Tucson, Arizona, 85724, United States
Central Arkansas VA
Little Rock, Arkansas, 72143, United States
Mission Cardiovascular Research Institute
Fremont, California, 94538, United States
Kaiser Permanente Los Angeles
Los Angeles, California, 90027, United States
USC/Keck Medical Center
Los Angeles, California, 90033, United States
James Meschia, MD
Mayo Clinic
First Submitted
June 30, 2022
First Posted
July 19, 2022
Study Start
July 5, 2022
Actual (reported)Primary Completion
August 31, 2027
EstimatedThe Correlation Between the Enzyme Paraoxigenase 1 (PON1) to Carotid Artery Atheromatous Plaque
INTERVENT risk factor management program to help manage patient's risk factors. The INTERVENT program will provide individualized risk factor counseling sessions (via telephone or internet) at regular interval by healthcare workers who are specially trained to help patients follow the medical management plan.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
University of California Los Angeles
Los Angeles, California, 90095, United States
Kaiser Permanente Divsion of Research
San Francisco, California, 94115, United States
Kaiser Permanente San Francisco
San Francisco, California, 94115, United States
St. Joseph's Medical Center
Stockton, California, 95204, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Yale New Haven Hospital
New Haven, Connecticut, 16520, United States
Morton Plant Mease Healthcare
Clearwater, Florida, 33756, United States
University of Florida Health at Shands
Gainesville, Florida, 32610, United States
Lyerly Neurosurgery/Baptist Health
Jacksonville, Florida, 32207, United States
University of Florida Jacksonville
Jacksonville, Florida, 32209, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Miami Cardiac and Vascular Institute
Miami, Florida, 33176, United States
Cardiovascular Institute NW Florida
Panama City, Florida, 32405, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Endeavor Health/NorthShore University
Evanston, Illinois, 60201, United States
Prairie Heart/St. John's Hospital
Springfield, Illinois, 62701, United States
Deaconess Heart Group
Newburgh, Indiana, 47630, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
Baptist Health
Lexington, Kentucky, 40503, United States
Ochsner Health System
New Orleans, Louisiana, 70121, United States
Maine Medical Center
Portland, Maine, 04102, United States
VA Medical Center
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
White Oak Medical Center
Silver Spring, Maryland, 20904, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
VA Ann Arbor
Ann Arbor, Michigan, 48105, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Michigan Vascular Center
Flint, Michigan, 48532, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Michigan Heart
Ypsilanti, Michigan, 48197, United States
North Memorial Medical Center
Golden Valley, Minnesota, 55422, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Mercy Hospital
St Louis, Missouri, 63141, United States
SUNY Buffalo
Buffalo, New York, 14203, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Crouse Hospital
Syracuse, New York, 13210, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Mercy Health St. Vincent
Toledo, Ohio, 43608, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Pinnacle Health
Harrisburg, Pennsylvania, 17043, United States
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
VA Pittsburgh
Pittsburgh, Pennsylvania, 15240, United States
Berks Cardiologists
Wyomissing, Pennsylvania, 19610, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660, United States
Tennova Healthcare
Knoxville, Tennessee, 37934, United States
Seton Medical Center
Austin, Texas, 78705, United States
University of Utah Hospitals & Clinics
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
VA Puget Sound
Seattle, Washington, 98108, United States
Gundersen Clinic, Ltd.
La Crosse, Wisconsin, 54601, United States
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A7, Canada
Hospital Clinic of Barcelona
Barcelona, 08036, Spain
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 28, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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