Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Stroke and death 4 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
Name Time Method Cognitive Function 4 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 Stroke 4 years if there are treatment differences in the incidence of major stroke at 4-years among all arms of the study
Effect modification 4 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.
Related Research Topics
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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
Scroll for more (157 remaining)The University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States