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Procedure

Carotid Stenting vs. Endarterectomy for Carotid Stenosis (CREST-2 Trial)

N/A
Waitlist Available
Led By Thomas G. Brott, MD
Research Sponsored by Thomas G. Brott, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients ≥35 years old
Life-long asymptomatic patients defined as having no medical history of stroke or transient ischemic attack and negative responses to all of the symptom items on the Questionnaire for Verifying Stroke-free Status (QVSS)
Must not have
Known malignancy other than basal cell non-melanoma skin cancer
Any major surgery, major trauma, revascularization procedure, or acute coronary syndrome within the past 1 month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two methods of preventing stroke in patients with asymptomatic high-grade carotid stenosis. One group will have endarterectomy and the other will have carotid stenting with embolic protection.

Who is the study for?
This trial is for adults over 35 with asymptomatic high-grade carotid stenosis, who haven't had a stroke or TIA related to the stenosis in the last 180 days. They must be able to follow the study schedule and not be pregnant if of childbearing potential. Exclusions include recent major surgery, severe kidney disease, planned major surgeries, certain cancers, and intolerance to study medications.
What is being tested?
The CREST-2 trial compares intensive medical management alone versus alongside either carotid endarterectomy (CEA) or carotid stenting (CAS) in preventing strokes. Participants are randomly assigned to one of these treatments and all receive uniform medical management directed by the study team.
What are the potential side effects?
Potential side effects from CEA might include nerve injury leading to numbness or pain, bleeding, infection at incision site, heart attack or stroke during surgery. CAS could cause similar issues plus risks associated with placing a stent like blood vessel damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 35 years old or older.
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I have never had a stroke or symptoms of a stroke.
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I have not had a stroke or mini-stroke on the same side as my narrowed artery in the last 6 months.
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My narrowed carotid artery can be treated with surgery or stenting.
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I am not able to have children or I have a negative pregnancy test.
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I am 35 years old or older.
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I am not able to have children or I have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a cancer diagnosis other than non-melanoma skin cancer.
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I haven't had any major surgery or serious heart issues in the last month.
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I am on the list or being evaluated for an organ transplant.
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I have a heart condition that could cause blood clots.
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I have had a major stroke on one side with lasting disability.
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I haven't had a serious brain bleed unrelated to blood thinners in the last year.
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I have a neurological condition that might be confused with a stroke.
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I have chronic atrial fibrillation.
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My heart's pumping ability is very weak.
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My lung function is severely reduced, with an expected lifespan of less than 4 years.
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My carotid artery narrowing is not due to hardening of the arteries.
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I have a blockage in the artery on the same side of my neck.
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I have a blood clot in the artery of my neck.
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I have a brain aneurysm larger than 5 mm on the same side.
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I am not eligible for a specific artery-clearing surgery.
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My platelet count is below 100,000 or I've had a bad reaction to heparin.
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I have severe chest pain that can't be treated with surgery.
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My kidney function is low, with creatinine ≥ 2.5 mg/dl or GFR < 30 cc/min.
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I haven't had a serious GI bleed in the last month.
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I have severe memory loss that affects my daily life.
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I have had atrial fibrillation or need long-term blood thinners.
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I refuse to receive blood transfusions.
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I understand and can follow the study's procedures and consent.
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I am extremely overweight.
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I am on blood thinners like warfarin or direct thrombin inhibitors.
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I have severe heart artery blockage in two or more main arteries that cannot be treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Stroke and death
Secondary study objectives
Cognitive Function
Effect modification
Major Stroke

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Intensive Medical Management - no CEAExperimental Treatment1 Intervention
Intensive Medical Management alone - no CEA
Group II: Intensive Medical Management - no CASExperimental Treatment1 Intervention
Intensive Medical Management alone - no CAS
Group III: Carotid Endarterectomy (CEA)Active Control1 Intervention
Carotid Endarterectomy
Group IV: Carotid Stenting (CAS)Active Control1 Intervention
Carotid Stenting

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,373 Previous Clinical Trials
648,552 Total Patients Enrolled
4 Trials studying Carotid Stenosis
5,543 Patients Enrolled for Carotid Stenosis
Thomas G. Brott, M.D.Lead Sponsor
Thomas G. Brott, MD5.01 ReviewsPrincipal Investigator - Mayo Clinic
Mayo Clinic

Media Library

Carotid endarterectomy (CEA) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02089217 — N/A
~262 spots leftby Feb 2026
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