CREST-2 Long-term Observational Extension Study

NCT ID: NCT05465122

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 2480 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-05
• Study Completion Date: 2026-02-28

Brief Summary

The purpose of this Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial (C2LOE - ClinicalTrials.gov Identifier: NCT02089217) study is to study is to assess post-procedural efficacy of carotid endarterectomy and carotid stenting.

Detailed Description

Atherosclerotic plaque in the carotid arteries is responsible for 10 to 15% of all ischemic strokes. The ongoing NINDS-funded CREST-2 multicenter randomized clinical trial is testing whether in the short term (up to 4 years after study entry) procedural revascularization improves stroke prevention above and beyond what can be achieved with intensive medical management of vascular risk factors, especially hypertension and hyperlipidemia. Our proposal is for an observational extension of the CREST-2 clinical trial to test whether revascularization improves stroke prevention in the clinically relevant long term (up to 8 to 10 years). The current application proposes to use a site-less, centralized telephone approach to extend the follow-up of CREST-2 trial participants for assessing the primary study outcome (stroke) for up to 10 years. The average follow-up will increase from between 2-3 years (clinic-based randomized trial) to 7-8 years (observational extension). Each patient will be contacted by telephone at 6-month intervals, and queried regarding all hospitalizations since the last contact. Suspected stroke events will be adjudicated by an expert clinical events committee based on medical record review.

Conditions

Stenoses, Carotid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Carotid Stenting Group (CAS)

Subjects assigned to the intensive medical management with carotid stenting group in the CREST-2 study (NCT02089217)

FDA-approved carotid stents

Intervention Type: PROCEDURE

This is the standard proven therapy for carotid stenosis that involves an arteriotomy followed by removal of plaque and reconstruction of the vessel.

Intensive Medical Management

Intervention Type: OTHER

INTERVENT risk factor management program to help manage patient's risk factors. The INTERVENT program will provide individualized risk factor counseling sessions (via telephone or internet) at regular interval by healthcare workers who are specially trained to help patients follow the medical management plan.

Carotid Endarterectomy Group (CEA)

Subjects assigned to the intensive medical management with carotid endarterectomy group in the CREST-2 study (NCT02089217)

Carotid Endarterectomy

Intervention Type: PROCEDURE

This is the standard proven therapy for carotid stenosis that involves an arteriotomy followed by removal of plaque and reconstruction of the vessel.

Intensive Medical Management

Intervention Type: OTHER

INTERVENT risk factor management program to help manage patient's risk factors. The INTERVENT program will provide individualized risk factor counseling sessions (via telephone or internet) at regular interval by healthcare workers who are specially trained to help patients follow the medical management plan.

Intensive Medical Management Group - no CAS

Subjects assigned to the intensive medical management alone with no carotid stenting (CAS) group in the CREST-2 study (NCT02089217)

Intensive Medical Management

Intervention Type: OTHER

INTERVENT risk factor management program to help manage patient's risk factors. The INTERVENT program will provide individualized risk factor counseling sessions (via telephone or internet) at regular interval by healthcare workers who are specially trained to help patients follow the medical management plan.

Intensive Medical Management Group - no CEA

Subjects assigned to the intensive medical management alone with no carotid endarterectomy (CEA) group in the CREST-2 study (NCT02089217)

Intensive Medical Management

Intervention Type: OTHER

INTERVENT risk factor management program to help manage patient's risk factors. The INTERVENT program will provide individualized risk factor counseling sessions (via telephone or internet) at regular interval by healthcare workers who are specially trained to help patients follow the medical management plan.

Interventions

Carotid Endarterectomy

This is the standard proven therapy for carotid stenosis that involves an arteriotomy followed by removal of plaque and reconstruction of the vessel.

Intervention Type: PROCEDURE

FDA-approved carotid stents

This is the standard proven therapy for carotid stenosis that involves an arteriotomy followed by removal of plaque and reconstruction of the vessel.

Intervention Type: PROCEDURE

Intensive Medical Management

INTERVENT risk factor management program to help manage patient's risk factors. The INTERVENT program will provide individualized risk factor counseling sessions (via telephone or internet) at regular interval by healthcare workers who are specially trained to help patients follow the medical management plan.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Currently active or graduated participants in the CREST-2 randomized trial
• Able to provide written informed consent by self
• Fluent in English or Spanish

Exclusion Criteria

• Unable to provide written informed consent
• Inability to follow study procedures

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

University of Maryland

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

James F. Meschia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Meschia, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic Pheonix

Phoenix, Arizona, United States

Banner University Medical Center

Tucson, Arizona, United States

Central Arkansas VA

Little Rock, Arkansas, United States

Mission Cardiovascular Research Institute

Fremont, California, United States

Kaiser Permanente Los Angeles

Los Angeles, California, United States

USC/Keck Medical Center

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

Kaiser Permanente Divsion of Research

San Francisco, California, United States

Kaiser Permanente San Francisco

San Francisco, California, United States

St. Joseph's Medical Center

Stockton, California, United States

Hartford Hospital

Hartford, Connecticut, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Morton Plant Mease Healthcare

Clearwater, Florida, United States

University of Florida Health at Shands

Gainesville, Florida, United States

Lyerly Neurosurgery/Baptist Health

Jacksonville, Florida, United States

University of Florida Jacksonville

Jacksonville, Florida, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Miami Cardiac and Vascular Institute

Miami, Florida, United States

Cardiovascular Institute NW Florida

Panama City, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Endeavor Health/NorthShore University

Evanston, Illinois, United States

Prairie Heart/St. John's Hospital

Springfield, Illinois, United States

Deaconess Heart Group

Newburgh, Indiana, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Baptist Health

Lexington, Kentucky, United States

Ochsner Health System

New Orleans, Louisiana, United States

Maine Medical Center

Portland, Maine, United States

VA Medical Center

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

White Oak Medical Center

Silver Spring, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

St. Elizabeth's Medical Center

Boston, Massachusetts, United States

VA Ann Arbor

Ann Arbor, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Michigan Vascular Center

Flint, Michigan, United States

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Michigan Heart

Ypsilanti, Michigan, United States

North Memorial Medical Center

Golden Valley, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Mercy Hospital

St Louis, Missouri, United States

SUNY Buffalo

Buffalo, New York, United States

Weill Cornell Medical College

New York, New York, United States

Crouse Hospital

Syracuse, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Mercy Health St. Vincent

Toledo, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Pinnacle Health

Harrisburg, Pennsylvania, United States

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, United States

VA Pittsburgh

Pittsburgh, Pennsylvania, United States

Berks Cardiologists

Wyomissing, Pennsylvania, United States

The Miriam Hospital

Providence, Rhode Island, United States

Wellmont CVA Heart Institute

Kingsport, Tennessee, United States

Tennova Healthcare

Knoxville, Tennessee, United States

Seton Medical Center

Austin, Texas, United States

University of Utah Hospitals & Clinics

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

VA Puget Sound

Seattle, Washington, United States

Gundersen Clinic, Ltd.

La Crosse, Wisconsin, United States

Vancouver General Hospital

Vancouver, British Columbia, Canada

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Hospital Clinic of Barcelona

Barcelona, , Spain

Countries

United States; Canada; Spain

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

1U01NS119169-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-007363

Identifier Type: -

Identifier Source: org_study_id