NCT02089217

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,486

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
5 countries

167 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

December 9, 2014

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

10.8 years

First QC Date

March 13, 2014

Last Update Submit

September 26, 2025

Conditions

Keywords

asymptomaticcarotidstentendarterectomyembolic protectionmedical managementhypertensionhyperlipidemiacognitionrisk factor control

Outcome Measures

Primary Outcomes (1)

  • Stroke and death

    The primary outcome is the composite of stroke plus death within 44 days after randomization and ipsilateral stroke thereafter up to 4 years.

    4 years

Secondary Outcomes (3)

  • Cognitive Function

    4 years

  • Major Stroke

    4 years

  • Effect modification

    4 years

Study Arms (4)

Carotid Endarterectomy (CEA)

ACTIVE COMPARATOR

Carotid Endarterectomy

Procedure: Carotid endarterectomy (CEA)

Carotid Stenting (CAS)

ACTIVE COMPARATOR

Carotid Stenting

Device: Carotid Stenting (CAS)

Intensive Medical Management - no CEA

EXPERIMENTAL

Intensive Medical Management alone - no CEA

Other: Intensive Medical Management - no CEA

Intensive Medical Management - no CAS

EXPERIMENTAL

Intensive Medical Management alone - no CAS

Other: Intensive Medical Management - no CAS

Interventions

Carotid endarterectomy

Carotid Endarterectomy (CEA)

Carotid stenting

Carotid Stenting (CAS)

Intensive Medical Management alone - no CEA

Intensive Medical Management - no CEA

Intensive Medical Management alone - no CAS

Intensive Medical Management - no CAS

Eligibility Criteria

Age35 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥35 years old.
  • Carotid stenosis defined as:
  • Stenosis ≥70% by catheter angiography (NASCET Criteria); OR
  • by Doppler ultrasonography (DUS) with ≥70% stenosis defined by a peak systolic velocity of at least 230 cm/s plus at least one of the following:
  • an end diastolic velocity ≥100 cm/s, or
  • internal carotid/common carotid artery peak systolic velocity ratio ≥4.0, or
  • computed tomography angiography (CTA) with ≥ 70% stenosis, or
  • magnetic resonance angiography (MRA) with ≥ 70% stenosis.
  • No medical history of stroke or transient ischemic attack (TIA) ipsilateral to the stenosis within 180 days of randomization. Life-long asymptomatic patients will be 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).
  • Patients must have a modified Rankin Scale (mRS) score of 0 or 1 at the time of informed consent.
  • Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization.
  • Patients must agree to comply with all protocol-specified follow-up appointments.
  • Patients must sign a consent form that has been approved by the local governing Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site.
  • Randomization to treatment group will apply to only one carotid artery for patients with bilateral carotid stenosis. Management of the non-randomized stenosis may be done in accordance with local PI recommendation. Treatment of the non-study internal carotid artery must take place at least 30 days prior to randomization, or greater than 44 days after randomization and 30 days after the study procedure is completed (whichever is longer).
  • Carotid stenosis must be treatable with carotid endarterectomy (CEA), carotid artery stenting (CAS), or either procedure.

You may not qualify if:

  • Intolerance or allergic reaction to a study medication without a suitable management alternative.
  • GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy.
  • Prior major ipsilateral stroke in the past with substantial residual disability (mRS ≥ 2) that is likely to confound study outcomes.
  • Severe dementia.
  • History of major symptomatic intracranial hemorrhage within 12 months that was not related to anticoagulation.
  • Prior Intracranial hemorrhage that the investigator believes represents a contraindication to the perioperative or periprocedural antithrombotic and antiplatelet treatments necessary to complete endarterectomy or stenting per protocol.
  • Current neurologic illness characterized by fleeting or fixed neurologic deficits that cannot be distinguished from TIA or stroke.
  • Patient objects to future blood transfusions.
  • Platelet count \<100,000/microliter or history of heparin-induced thrombocytopenia.
  • Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin inhibitor, or anti-Xa agents.
  • Chronic atrial fibrillation, unless the patient has had successful atrial appendage closure (e.g., Watchman Device) and no longer requires chronic therapeutic anticoagulation.
  • Any episode of atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation that is deemed to require chronic anticoagulation.
  • Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area \< 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired patent foramen ovale (PFO) with prior paradoxical embolism.
  • Unstable angina defined as rest angina with electrocardiogram (ECG) changes that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization).
  • Left Ventricular Ejection fraction \<30% or admission for heart failure in prior 6 months.
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (167)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Huntsville Hospital/ Heart Center Research Alabama

Huntsville, Alabama, 35801, United States

Location

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

St. Joseph's Hospital and Medical Center/Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Abrazo Arizona Heart Hospital

Phoenix, Arizona, 85016, United States

Location

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, 85251, United States

Location

Banner University Medical Center

Tucson, Arizona, 85724, United States

Location

Central Arkansas Veteran's Healthcare System

Little Rock, Arkansas, 72143, United States

Location

Mission Cardiovascular Research Institute

Fremont, California, 94538, United States

Location

Mission Cardiovascular Research

Fremont, California, 94538, United States

Location

University of California Irvine

Irvine, California, 92868, United States

Location

UC San Diego Health

La Jolla, California, 92037, United States

Location

Kaiser Permanente Los Angeles

Los Angeles, California, 90027, United States

Location

Keck Medical Center of University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

Kaiser Permanente

San Diego, California, 92116, United States

Location

Kaiser Permanente Northern California

San Francisco, California, 94115, United States

Location

University of California San Francisco

San Francisco, California, 94115, United States

Location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

St. Joseph's Medical Center

Stockton, California, 95204, United States

Location

Providence Little Company of Mary Medical Center

Torrance, California, 90503, United States

Location

St. Mary's Hospital Regional Medical Center

Grand Junction, Colorado, 81501, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Medstar/Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

University of Florida Health at Shands

Gainesville, Florida, 32610, United States

Location

Lyerly Neurosurgery

Jacksonville, Florida, 32207, United States

Location

UF Jacksonville

Jacksonville, Florida, 32209, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32216, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Miami Cardiac and Vascular Institute at Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Mount Sinai Medical Center of Florida

Miami Beach, Florida, 33140, United States

Location

Cardiovascular Institute of Northwest Florida

Panama City, Florida, 32401, United States

Location

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

Location

Tampa General/University of South Florida

Tampa, Florida, 33606, United States

Location

Atlanta VA Medical Center

Atlanta, Georgia, 30033, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Southern Illinois Healthcare

Carbondale, Illinois, 62901, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Northshore University

Evanston, Illinois, 60201, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Mercy Health Riverside

Rockford, Illinois, 61114, United States

Location

Prairie Heart/St. John's Hospital

Springfield, Illinois, 62701, United States

Location

Franciscan St. Francis Health

Indianapolis, Indiana, 46237, United States

Location

Deaconess Heart Group

Newburgh, Indiana, 47630, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

University of Kentucky Hospital

Lexington, Kentucky, 40536, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Tulane University Heart and Vascular

New Orleans, Louisiana, 70112, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

University of Maryland VA

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Medical Institution

Baltimore, Maryland, 21224, United States

Location

White Oak Medical Center

Takoma Park, Maryland, 20912, United States

Location

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

Location

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, 02215, United States

Location

University of Massachusetts Memorial Hospital

Worcester, Massachusetts, 01605, United States

Location

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan Hospital and Health Systems

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Michigan Vascular Center/McLaren- Flint

Flint, Michigan, 48532, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

Location

Cardiac and Vascular Research Center of Northern Michigan/McLaren Northern Michigan

Petoskey, Michigan, 49770, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Trinity Health/Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Minneapolis Clinic of Neurology, Ltd./North Memorial Medical Center

Golden Valley, Minnesota, 55422, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

St. Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

Cox Medical Center

Springfield, Missouri, 65807, United States

Location

Mercy Medical Research Institute

Springfield, Missouri, 65807, United States

Location

John Cochran VA Medical Center

St Louis, Missouri, 63106, United States

Location

Mercy Hospital

St Louis, Missouri, 63141, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Cooper University

Camden, New Jersey, 08103, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

SUNY Buffalo

Buffalo, New York, 14203, United States

Location

The Feinstein Institute of Medical Research/Northwell Health

Manhasset, New York, 11030, United States

Location

Mount Sinai Hospital New York

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Crouse Hospital

Syracuse, New York, 13210, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

North Carolina Heart & Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Coastal Carolina Surgical Associates PA

Wilmington, North Carolina, 28401, United States

Location

Novant Health/Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Sanford Health

Fargo, North Dakota, 58104, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Ohio State Medical Center

Columbia, Ohio, 43210, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

Jobst Vascular Institute/University of Toledo

Toledo, Ohio, 43606, United States

Location

Mercy Health St. Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

St. John Clinical Research Institute

Tulsa, Oklahoma, 74104, United States

Location

Providence Brain and Spine Institute

Portland, Oregon, 97225, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital - Network Office of Research

Allentown, Pennsylvania, 18103, United States

Location

UPMC Altoona

Altoona, Pennsylvania, 16601, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

UPMC Hamot

Erie, Pennsylvania, 16550, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC Presbyterian University Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

VA Pittsburgh Healthcare

Pittsburgh, Pennsylvania, 15240, United States

Location

Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, 17043, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Berks Cardiologists / St. Joseph's Medical Center

Wyomissing, Pennsylvania, 19610, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

North Central Heart Institute

Sioux Falls, South Dakota, 57108, United States

Location

CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Tennova Healthcare/ Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38017, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Seton Medical Center Austin

Austin, Texas, 78705, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Valley Baptist Medical Center

Harlingen, Texas, 78551, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Utah Hospitals and Clinics

Salt Lake City, Utah, 84132, United States

Location

George E. Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, Utah, 84148, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Health Care

Falls Church, Virginia, 22042, United States

Location

Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

Overlake Hospital

Bellevue, Washington, 98004, United States

Location

University of Washington Medicine-Harborview Medical Center

Seattle, Washington, 98104, United States

Location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

West Virginia University

Morgantown, West Virginia, 26554, United States

Location

Gundersen Clinic, Ltd

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Hospitals & Clinics

Madison, Wisconsin, 53792, United States

Location

Fiona Stanley Hospital

Perth, Australia

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 3A7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

St. Boniface Hospital

Winnipeg, Ontario, R2H 2A6, Canada

Location

CHU de Québec/ Hôpital de l'Enfant-Jésus

Québec, Quebec, G1J1Z4, Canada

Location

Soroka University Medical Center

Beersheba, Israel

Location

Soroka University Vascular Surgery

Beersheba, Israel

Location

Rambam Healthcare

Haifa, 3109601, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Shaare-Zedek Medical Center

Jerusalem, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

Related Publications (12)

  • Brott TG, Howard G, Lal BK, Voeks JH, Turan TN, Roubin GS, Lazar RM, Brown RD Jr, Huston J 3rd, Edwards LJ, Jones M, Clark WM, Chamorro A, Llull L, Mena-Hurtado C, Heck D, Marshall RS, Howard VJ, Moore WS, Barrett KM, Demaerschalk BM, Sangha N, Aronow H, Foster M, Sternbergh WC 3rd, Shawl F, Lanzino G, Rapp J, Tran HS, Ecker R, Mackey A, Ali V, Given C 2nd, Teal P, Kashyap VS, Mukherjee D, Harrigan M, Silverman S, Koopmann M, Wadley VG, Zhang Y, Rhodes JD, Chaturvedi S, Meschia JF; CREST-2 Investigators. Medical Management and Revascularization for Asymptomatic Carotid Stenosis. N Engl J Med. 2026 Jan 15;394(3):219-231. doi: 10.1056/NEJMoa2508800. Epub 2025 Nov 21.

  • Meschia JF, Lal B, Roubin G, Turan TN, Howard VJ, Benson RT, Carman K, Howard G, Brott TG. Adapting to Evolving Technologies and Treatment Guidelines in a Procedural Trial: A Qualitative Review of the CREST-2 Experience. Neurology. 2023 May 30;100(22):1060-1066. doi: 10.1212/WNL.0000000000207075. Epub 2023 Feb 6.

  • Kamtchum-Tatuene J, Saba L, Heldner MR, Poorthuis MHF, de Borst GJ, Rundek T, Kakkos SK, Chaturvedi S, Topakian R, Polak JF, Jickling GC; Carotid Atherosclerosis and Stroke Collaboration (CASCO). Interleukin-6 Predicts Carotid Plaque Severity, Vulnerability, and Progression. Circ Res. 2022 Jul 8;131(2):e22-e33. doi: 10.1161/CIRCRESAHA.122.320877. Epub 2022 Jun 17.

  • Lazar RM, Wadley VG, Myers T, Jones MR, Heck DV, Clark WM, Marshall RS, Howard VJ, Voeks JH, Manly JJ, Moy CS, Chaturvedi S, Meschia JF, Lal BK, Brott TG, Howard G. Baseline Cognitive Impairment in Patients With Asymptomatic Carotid Stenosis in the CREST-2 Trial. Stroke. 2021 Dec;52(12):3855-3863. doi: 10.1161/STROKEAHA.120.032972. Epub 2021 Aug 26.

  • Haley W, Shawl F, Charles Sternbergh W 3rd, Turan TN, Barrett K, Voeks J, Brott T, Meschia JF. Non-Adherence to Antihypertensive Guidelines in Patients with Asymptomatic Carotid Stenosis. J Stroke Cerebrovasc Dis. 2021 Aug;30(8):105918. doi: 10.1016/j.jstrokecerebrovasdis.2021.105918. Epub 2021 Jun 18.

  • Turan TN, Meschia JF, Chimowitz MI, Roldan A, LeMatty T, Luke S, Breathitt L, Eiland R, Foley J, Brott TG. Mitigating the effects of COVID-19 pandemic on controlling vascular risk factors among participants in a carotid stenosis trial. J Stroke Cerebrovasc Dis. 2020 Dec;29(12):105362. doi: 10.1016/j.jstrokecerebrovasdis.2020.105362. Epub 2020 Sep 30.

  • Turan TN, Voeks JH, Chimowitz MI, Roldan A, LeMatty T, Haley W, Lopes-Virella M, Chaturvedi S, Jones M, Heck D, Howard G, Lal BK, Meschia JF, Brott TG. Rationale, Design, and Implementation of Intensive Risk Factor Treatment in the CREST2 Trial. Stroke. 2020 Oct;51(10):2960-2971. doi: 10.1161/STROKEAHA.120.030730. Epub 2020 Sep 21.

  • Lal BK, Meschia JF, Roubin GS, Jankowitz B, Heck D, Jovin T, White CJ, Rosenfield K, Katzen B, Dabus G, Gray W, Matsumura J, Hopkins LN, Luke S, Sharma J, Voeks JH, Howard G, Brott TG; CREST-2 Investigators. Factors influencing credentialing of interventionists in the CREST-2 trial. J Vasc Surg. 2020 Mar;71(3):854-861. doi: 10.1016/j.jvs.2019.05.035. Epub 2019 Jul 26.

  • Musialek P, Roubin GS. Commentary: Double-Layer Carotid Stents: From the Clinical Need, through a Stent-in-Stent Strategy, to Effective Plaque Isolation... the Journey Toward Safe Carotid Revascularization Using the Endovascular Route. J Endovasc Ther. 2019 Aug;26(4):572-577. doi: 10.1177/1526602819861546. No abstract available.

  • Lal BK, Meschia JF, Brott TG. Clinical need, design, and goals for the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis trial. Semin Vasc Surg. 2017 Mar;30(1):2-7. doi: 10.1053/j.semvascsurg.2017.04.004. Epub 2017 Apr 27.

  • Demaerschalk BM, Brown RD Jr, Roubin GS, Howard VJ, Cesko E, Barrett KM, Longbottom ME, Voeks JH, Chaturvedi S, Brott TG, Lal BK, Meschia JF, Howard G; CREST-2 Investigators. Factors Associated With Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial. Stroke. 2017 Sep;48(9):2511-2518. doi: 10.1161/STROKEAHA.117.016976. Epub 2017 Aug 2.

  • Howard VJ, Meschia JF, Lal BK, Turan TN, Roubin GS, Brown RD Jr, Voeks JH, Barrett KM, Demaerschalk BM, Huston J 3rd, Lazar RM, Moore WS, Wadley VG, Chaturvedi S, Moy CS, Chimowitz M, Howard G, Brott TG; CREST-2 study investigators. Carotid revascularization and medical management for asymptomatic carotid stenosis: Protocol of the CREST-2 clinical trials. Int J Stroke. 2017 Oct;12(7):770-778. doi: 10.1177/1747493017706238. Epub 2017 May 2.

Related Links

MeSH Terms

Conditions

Carotid StenosisHypertensionHyperlipidemias

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • James F. Meschia, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
  • Brajesh K. Lal, MD

    University of Maryland

    PRINCIPAL INVESTIGATOR
  • George Howard, DrPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR
  • Lloyd Edwards, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 17, 2014

Study Start

December 9, 2014

Primary Completion

September 12, 2025

Study Completion

September 12, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations