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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

Not Applicable
Active, not recruiting
Conditions
Carotid Stenosis
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Stroke and death4 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
NameTimeMethod
Cognitive Function4 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 Stroke4 years

if there are treatment differences in the incidence of major stroke at 4-years among all arms of the study

Effect modification4 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)

The University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

Cardiovascular Associates/Brookwood Medical Center

🇺🇸

Birmingham, Alabama, United States

Huntsville Hospital/ Heart Center Research Alabama

🇺🇸

Huntsville, Alabama, United States

Banner University Medical Center

🇺🇸

Tucson, Arizona, United States

St. Joseph's Hospital and Medical Center/Barrow Neurological Institute

🇺🇸

Phoenix, Arizona, United States

Abrazo Arizona Heart Hospital

🇺🇸

Phoenix, Arizona, United States

Mayo Clinic Arizona

🇺🇸

Phoenix, Arizona, United States

HonorHealth Scottsdale Osborn Medical Center

🇺🇸

Scottsdale, Arizona, United States

Central Arkansas Veteran's Healthcare System

🇺🇸

Little Rock, Arkansas, United States

Mission Cardiovascular Research Institute

🇺🇸

Fremont, California, United States

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The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States

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