Carotid Stenting vs. Endarterectomy for Carotid Stenosis

(CREST-2 Trial)

Recruiting in Palo Alto (17 mi)

+191 other locations

Overseen by James F. Meschia, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

George Howard, DrPH

Principal Investigator

University of Alabama at Birmingham

Lloyd Edwards, PhD

Principal Investigator

University of Alabama at Birmingham

Brajesh K. Lal, MD

Principal Investigator

University of Maryland

James F. Meschia, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I am 35 years old or older.

I have never had a stroke or symptoms of a stroke.

Patients must agree to comply with all protocol-specified follow-up appointments

Exclusion Criteria

I have a cancer diagnosis other than non-melanoma skin cancer.

I haven't had any major surgery or serious heart issues in the last month.

I have a heart condition that could cause blood clots.

Treatment Details

Interventions

• Carotid endarterectomy (CEA) (Procedure)
• Carotid Stenting (CAS) (Device)
• Intensive Medical Management - no CAS (Other)
• Intensive Medical Management - no CEA (Other)

Trial Overview 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.

Participant Groups

Group I: Intensive Medical Management - no CEA Experimental Treatment 1 Intervention

Intensive Medical Management alone - no CEA

Group II: Intensive Medical Management - no CAS Experimental Treatment 1 Intervention

Intensive Medical Management alone - no CAS

Group III: Carotid Endarterectomy (CEA) Active Control 1 Intervention

Carotid Endarterectomy

Group IV: Carotid Stenting (CAS) Active Control 1 Intervention

Carotid Stenting

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

Thomas G. Brott, M.D.

Lead Sponsor

Trials

1

Recruited

2,500+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Jordan Gladman

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Medical Officer

MD from Harvard Medical School

Walter J. Koroshetz

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Executive Officer since 2007

MD from the University of Chicago