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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

NCT02089217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2486

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

  • Carotid Stenosis

Interventions

PROCEDURE

Carotid endarterectomy (CEA)

Carotid endarterectomy

DEVICE

Carotid Stenting (CAS)

Carotid stenting

OTHER

Intensive Medical Management - no CEA

Intensive Medical Management alone - no CEA

OTHER

Intensive Medical Management - no CAS

Intensive Medical Management alone - no CAS

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • James F. Meschia, MD · Mayo Clinic

  • Brajesh K. Lal, MD · University of Maryland

  • George Howard, DrPH · University of Alabama at Birmingham

  • Lloyd Edwards, PhD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-09
Primary Completion
2025-09-12
Completion
2025-09-12
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • Israel
  • 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 NCT02089217 on ClinicalTrials.gov