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CREST-2 Long-term Observational Extension Study

NCT05465122 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 2480

Last updated 2025-09-05

No results posted yet for this 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.

Conditions

  • Stenoses, Carotid

Interventions

PROCEDURE

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.

PROCEDURE

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.

OTHER

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.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Alabama at Birmingham

    collaborator OTHER

  • University of Maryland

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • James Meschia, MD · Mayo Clinic

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • United States
  • Canada
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05465122 on ClinicalTrials.gov