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Active, not recruiting Observational

CREST-2 Long-term Observational Extension Study

NCT05465122 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2022-07-05
Last updated
2026-05-28

Condition(s) studied

Stenoses, Carotid

Investigational drug(s) / intervention(s)

Carotid EndarterectomyFDA-approved carotid stentsIntensive Medical Management

Carotid Endarterectomy: This is the standard proven therapy for carotid stenosis that involves an arteriotomy followed by removal of plaque and reconstruction of the vessel.

FDA-approved carotid stents: This is the standard proven therapy for carotid stenosis that involves an arteriotomy followed by removal of plaque and reconstruction of the vessel.

Intensive Medical Management: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
35 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Currently active or graduated participants in the CREST-2 randomized trial * Able to provide written informed consent by self * Fluent in English or Spanish Exclusion Criteria: * Unable to provide written informed consent * Inability to follow study procedures

Primary outcome measure(s)

  • Stroke — 5 years
    Number of participants to experience a stroke

Trial sites (64)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
Mayo Clinic Pheonix Phoenix Arizona
Banner University Medical Center Tucson Arizona
Central Arkansas VA Little Rock Arkansas
Mission Cardiovascular Research Institute Fremont California
Kaiser Permanente Los Angeles Los Angeles California
USC/Keck Medical Center Los Angeles California
University of California Los Angeles Los Angeles California
Kaiser Permanente Divsion of Research San Francisco California
Kaiser Permanente San Francisco San Francisco California
St. Joseph's Medical Center Stockton California
Hartford Hospital Hartford Connecticut
Yale New Haven Hospital New Haven Connecticut
Morton Plant Mease Healthcare Clearwater Florida
University of Florida Health at Shands Gainesville Florida
Lyerly Neurosurgery/Baptist Health Jacksonville Florida
University of Florida Jacksonville Jacksonville Florida
Mayo Clinic Jacksonville Jacksonville Florida
Miami Cardiac and Vascular Institute Miami Florida
Cardiovascular Institute NW Florida Panama City Florida
University of Chicago Medical Center Chicago Illinois
Endeavor Health/NorthShore University Evanston Illinois
Prairie Heart/St. John's Hospital Springfield Illinois
Deaconess Heart Group Newburgh Indiana
University of Iowa Hospitals & Clinics Iowa City Iowa
Baptist Health Lexington Kentucky
Ochsner Health System New Orleans Louisiana
Maine Medical Center Portland Maine
VA Medical Center Baltimore Maryland
Johns Hopkins University Baltimore Maryland
White Oak Medical Center Silver Spring Maryland
Massachusetts General Hospital Boston Massachusetts
St. Elizabeth's Medical Center Boston Massachusetts
VA Ann Arbor Ann Arbor Michigan
Henry Ford Health System Detroit Michigan
Michigan Vascular Center Flint Michigan
Sparrow Clinical Research Institute Lansing Michigan
Michigan Heart Ypsilanti Michigan
North Memorial Medical Center Golden Valley Minnesota
Mayo Clinic Rochester Rochester Minnesota

+ 24 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05465122 on ClinicalTrials.gov ↗ ← All trials in Spain