CREST-2 Long-term Observational Extension Study

• Conditions: Stenoses, Carotid
• Interventions: Procedure: FDA-approved carotid stents; Procedure: Carotid Endarterectomy; Other: Intensive Medical Management

• Registration Number: NCT05465122
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2022-06-30
• Study Start: 2022-07-05
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2480

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carotid Stenting Group (CAS)	FDA-approved carotid stents	Subjects assigned to the intensive medical management with carotid stenting group in the CREST-2 study (NCT02089217)
Carotid Stenting Group (CAS)	Intensive Medical Management	Subjects assigned to the intensive medical management with carotid stenting group in the CREST-2 study (NCT02089217)
Carotid Endarterectomy Group (CEA)	Carotid Endarterectomy	Subjects assigned to the intensive medical management with carotid endarterectomy group in the CREST-2 study (NCT02089217)
Intensive Medical Management Group - no CAS	Intensive Medical Management	Subjects assigned to the intensive medical management alone with no carotid stenting (CAS) group in the CREST-2 study (NCT02089217)
Carotid Endarterectomy Group (CEA)	Intensive Medical Management	Subjects assigned to the intensive medical management with carotid endarterectomy group in the CREST-2 study (NCT02089217)
Intensive Medical Management Group - no CEA	Intensive Medical Management	Subjects assigned to the intensive medical management alone with no carotid endarterectomy (CEA) group in the CREST-2 study (NCT02089217)

Primary Outcome Measures

Name	Time	Method
Stroke	5 years	Number of participants to experience a stroke

Trial Locations

Locations (51)

USC/Keck Medical Center; 🇺🇸 Los Angeles, California, United States

VA Medical Center; 🇺🇸 Baltimore, Maryland, United States

Miami Cardiac and Vascular Institute; 🇺🇸 Miami, Florida, United States

Mayo Clinic Pheonix; 🇺🇸 Phoenix, Arizona, United States

Banner University Medical Center; 🇺🇸 Tucson, Arizona, United States

Mission Cardiovascular Research Institute; 🇺🇸 Fremont, California, United States

Kaiser Permanente Los Angeles; 🇺🇸 Los Angeles, California, United States

Kaiser Permanente Divsion of Research; 🇺🇸 San Francisco, California, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

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

Central Arkansas VA; 🇺🇸 Little Rock, Arkansas, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Kaiser Permanente San Francisco; 🇺🇸 San Francisco, California, United States

St. Joseph's Medical Center; 🇺🇸 Stockton, California, United States

Mortan Plant Mease Healthcare; 🇺🇸 Clearwater, 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

University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, United States

Cardiovascular Institute NW Florida; 🇺🇸 Panama City, Florida, United States

Prairie Heart/St. John's Hospital; 🇺🇸 Springfield, Illinois, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Deaconess Heart Group; 🇺🇸 Newburgh, Indiana, United States

Baptist Health; 🇺🇸 Lexington, Kentucky, United States

Maine Medical Center; 🇺🇸 Portland, Maine, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

St. Elizabeth's Medical Center; 🇺🇸 Boston, Massachusetts, United States

White Oak Medical Center; 🇺🇸 Silver Spring, Maryland, United States

Michigan Vascular Center; 🇺🇸 Flint, Michigan, United States

Sparrow Clinical Research Institute; 🇺🇸 Lansing, Michigan, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

North Memorial Medical Center; 🇺🇸 Golden Valley, Minnesota, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Mercy Hospital; 🇺🇸 Saint Louis, Missouri, United States

Mercy Health St. Vincent; 🇺🇸 Toledo, Ohio, United States

Tennova Healthcare; 🇺🇸 Knoxville, Tennessee, United States

Pinnacle Health; 🇺🇸 Harrisburg, Pennsylvania, United States

VA Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Berks Cardiologists; 🇺🇸 Wyomissing, Pennsylvania, United States

Gundersen Clinic, Ltd.; 🇺🇸 La Crosse, Wisconsin, United States

University of Utah Hospitals & Clinics; 🇺🇸 Salt Lake City, Utah, United States

VA Puget Sound; 🇺🇸 Seattle, Washington, United States

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain

VA Ann Arbor; 🇺🇸 Ann Arbor, Michigan, United States

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States

University of Florida Health at Shands; 🇺🇸 Gainesville, Florida, United States

Ochsner Health System; 🇺🇸 New Orleans, Louisiana, United States