Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

NCT ID: NCT02089217

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2486 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-09

Study Completion Date

2025-09-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Prevention of stroke involves managing and treating risk factors. Most strokes are caused when blood flow to a portion of the brain is blocked. One place this often happens is in the carotid artery. This blockage is called atherosclerosis or hardening of the arteries.

The purpose of this trial is to determine the best way to prevent strokes in people who have a high amount of blockage of their carotid artery but no stroke symptoms related to that blockage. Each eligible participant will be evaluated to determine which procedure(s) is best for him/her. All participants will receive intensive medical treatment. In addition, participants will be randomized to receive the selected procedure or not.

The trial will be conducted in the United States and Canada by physicians carefully selected on their ability to perform the procedures at low risk. Another key component of the trial is that important stroke risk factors, including hypertension, diabetes, high cholesterol, cigarette smoking, physical activity, and diet will be managed intensively. Participants will remain in the study for 4 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carotid Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Carotid Endarterectomy (CEA)

Carotid Endarterectomy

Group Type ACTIVE_COMPARATOR

Carotid endarterectomy (CEA)

Intervention Type PROCEDURE

Carotid endarterectomy

Carotid Stenting (CAS)

Carotid Stenting

Group Type ACTIVE_COMPARATOR

Carotid Stenting (CAS)

Intervention Type DEVICE

Carotid stenting

Intensive Medical Management - no CEA

Intensive Medical Management alone - no CEA

Group Type EXPERIMENTAL

Intensive Medical Management - no CEA

Intervention Type OTHER

Intensive Medical Management alone - no CEA

Intensive Medical Management - no CAS

Intensive Medical Management alone - no CAS

Group Type EXPERIMENTAL

Intensive Medical Management - no CAS

Intervention Type OTHER

Intensive Medical Management alone - no CAS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carotid endarterectomy (CEA)

Carotid endarterectomy

Intervention Type PROCEDURE

Carotid Stenting (CAS)

Carotid stenting

Intervention Type DEVICE

Intensive Medical Management - no CEA

Intensive Medical Management alone - no CEA

Intervention Type OTHER

Intensive Medical Management - no CAS

Intensive Medical Management alone - no CAS

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients ≥35 years old.
2. 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:

1. an end diastolic velocity ≥100 cm/s, or
2. internal carotid/common carotid artery peak systolic velocity ratio ≥4.0, or
3. computed tomography angiography (CTA) with ≥ 70% stenosis, or
4. magnetic resonance angiography (MRA) with ≥ 70% stenosis.
3. 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).
4. Patients must have a modified Rankin Scale (mRS) score of 0 or 1 at the time of informed consent.
5. Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization.
6. Patients must agree to comply with all protocol-specified follow-up appointments.
7. 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.
8. 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).
9. Carotid stenosis must be treatable with carotid endarterectomy (CEA), carotid artery stenting (CAS), or either procedure.

Exclusion Criteria

1. Intolerance or allergic reaction to a study medication without a suitable management alternative.
2. GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy.
3. Prior major ipsilateral stroke in the past with substantial residual disability (mRS ≥ 2) that is likely to confound study outcomes.
4. Severe dementia.
5. History of major symptomatic intracranial hemorrhage within 12 months that was not related to anticoagulation.
6. 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.
7. Current neurologic illness characterized by fleeting or fixed neurologic deficits that cannot be distinguished from TIA or stroke.
8. Patient objects to future blood transfusions.
9. Platelet count \<100,000/microliter or history of heparin-induced thrombocytopenia.
10. Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin inhibitor, or anti-Xa agents.
11. Chronic atrial fibrillation, unless the patient has had successful atrial appendage closure (e.g., Watchman Device) and no longer requires chronic therapeutic anticoagulation.
12. Any episode of atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation that is deemed to require chronic anticoagulation.
13. 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.
14. 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).
15. Left Ventricular Ejection fraction \<30% or admission for heart failure in prior 6 months.
16. Respiratory insufficiency with life expectancy \< 4 years or forced expiratory volume (FEV1) \<30% of predicted value.
17. Known malignancy other than basal cell non-melanoma skin cancer. There are two exceptions to this rule: patients with prior cancer treatment and no recurrence for \>5 years are eligible for enrollment and cancer patients with life expectancy of greater than 5 years are eligible for enrollment.
18. Any major surgery, major trauma, revascularization procedure, or acute coronary syndrome within the past 1 month.
19. Either the serum creatinine is ≥ 2.5 mg/dl or the estimated glomerular filtration rate (GFR) is \< 30 cc/min.
20. Major (non-carotid) surgery/procedures planned within 3 months after enrollment.
21. Currently listed or being evaluated for major organ transplantation (i.e. heart, lung, liver, kidney).
22. Actively participating in another drug or aortic arch or cerebrovascular device trial for which participation in CREST-2 would be compromised with regard to follow-up assessment of outcomes or continuation in CREST-2.
23. Inability to understand and cooperate with study procedures or provide informed consent.
24. Non-atherosclerotic carotid stenosis (dissection, fibromuscular dysplasia, or stenosis following radiation therapy).
25. Previous ipsilateral CEA or CAS.
26. Ipsilateral internal or common carotid artery occlusion.
27. Intra-carotid floating thrombus.
28. Ipsilateral intracranial aneurysm \> 5 mm.
29. Extreme morbid obesity that would compromise patient safety during the procedure or would compromise patient safety during the periprocedural period.
30. Coronary artery disease with two or more proximal or major diseased coronary arteries with 70% stenosis that have not, or cannot, be revascularized.


Patients who are being considered for revascularization by CEA must not have any of the following criteria:

1. Serious adverse reaction to anesthesia not able to be overcome by pre-medication.
2. Distal/intracranial stenosis greater than index lesion.
3. Any of the following anatomical: radical neck dissection; surgically inaccessible lesions (e.g. above cervical spine level 2 (C2)); adverse neck anatomy that limits surgical exposure (e.g. spinal immobility - inability to flex neck beyond neutral or kyphotic deformity, or short obese neck); presence of tracheostomy stoma; laryngeal nerve palsy contralateral to target vessel; or previous extracranial-intracranial or subclavian bypass procedure ipsilateral to the target vessel.


Patients who are being considered for revascularization by CAS must not have any of the following criteria:

1. Allergy to intravascular contrast dye not amenable to pre-medication.
2. Type III, aortic arch anatomy.
3. Angulation or tortuosity (≥ 90 degree) of the innominate and common carotid artery that precludes safe, expeditious sheath placement or that will transmit a severe loop to the internal carotid after sheath placement.
4. Severe angulation or tortuosity of the internal carotid artery (including calyceal origin from the carotid bifurcation) that precludes safe deployment of embolic protection device or stent. Severe tortuosity is defined as 2 or more ≥ 90 degree angles within 4 cm of the target stenosis.
5. Proximal/ostial common carotid artery (CCA), innominate stenosis or distal/intracranial stenosis greater than index lesion.

Excessive circumferential calcification of the stenotic lesion defined as \>3mm thickness of calcification seen in orthogonal views on fluoroscopy.(Note: Anatomic considerations such as tortuosity, arch anatomy, and calcification must be evaluated even more carefully in elderly subjects (≥ 70 years).)
6. Target ICA vessel reference diameter \<4.0 mm or \>9.0 mm. Target internal carotid artery (ICA) measurements may be made from angiography of the contralateral artery. The reference diameter must be appropriate for the devices to be used.
7. Inability to deploy or utilize an FDA-approved Embolic Protection Device (EPD).
8. Non-contiguous lesions and long lesions (\>3 cm).
9. Qualitative characteristics of stenosis and stenosis-length of the carotid bifurcation (common carotid) and/or ipsilateral external carotid artery, that preclude safe sheath placement.
10. Occlusive or critical ilio-femoral disease including severe tortuosity or stenosis that necessitates additional endovascular procedures to facilitate access to the aortic arch or that prevents safe and expeditious femoral access to the aortic arch. "String sign" of the ipsilateral common or internal carotid artery.
11. Angiographic, computed tomography (CT), magnetic resonance (MR) or ultrasound evidence of severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries that would preclude safe passage of the sheath and other endovascular devices to the target artery as needed for carotid stenting.
Minimum Eligible Age

35 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

James F. Meschia

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James F. Meschia, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Brajesh K. Lal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

George Howard, DrPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Lloyd Edwards, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Huntsville Hospital/ Heart Center Research Alabama

Huntsville, Alabama, United States

Site Status

Banner University Medical Center

Phoenix, Arizona, United States

Site Status

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

Phoenix, Arizona, United States

Site Status

Abrazo Arizona Heart Hospital

Phoenix, Arizona, United States

Site Status

Mayo Clinic Arizona

Phoenix, Arizona, United States

Site Status

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, United States

Site Status

Banner University Medical Center

Tucson, Arizona, United States

Site Status

Central Arkansas Veteran's Healthcare System

Little Rock, Arkansas, United States

Site Status

Mission Cardiovascular Research Institute

Fremont, California, United States

Site Status

Mission Cardiovascular Research

Fremont, California, United States

Site Status

University of California Irvine

Irvine, California, United States

Site Status

UC San Diego Health

La Jolla, California, United States

Site Status

Kaiser Permanente Los Angeles

Los Angeles, California, United States

Site Status

Keck Medical Center of University of Southern California

Los Angeles, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

University of California Los Angeles (UCLA)

Los Angeles, California, United States

Site Status

VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status

University of California San Diego

San Diego, California, United States

Site Status

Kaiser Permanente

San Diego, California, United States

Site Status

Kaiser Permanente Northern California

San Francisco, California, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

San Francisco VA Medical Center

San Francisco, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

St. Joseph's Medical Center

Stockton, California, United States

Site Status

Providence Little Company of Mary Medical Center

Torrance, California, United States

Site Status

St. Mary's Hospital Regional Medical Center

Grand Junction, Colorado, United States

Site Status

Medical Center of the Rockies

Loveland, Colorado, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Medstar/Washington Hospital Center

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

Site Status

Morton Plant Hospital

Clearwater, Florida, United States

Site Status

University of Florida Health at Shands

Gainesville, Florida, United States

Site Status

Lyerly Neurosurgery

Jacksonville, Florida, United States

Site Status

UF Jacksonville

Jacksonville, Florida, United States

Site Status

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Site Status

Mayo Clinic

Jacksonville, Florida, United States

Site Status

University of Miami Hospital

Miami, Florida, United States

Site Status

Miami Cardiac and Vascular Institute at Baptist Hospital of Miami

Miami, Florida, United States

Site Status

Mount Sinai Medical Center of Florida

Miami Beach, Florida, United States

Site Status

Cardiovascular Institute of Northwest Florida

Panama City, Florida, United States

Site Status

Tallahassee Neurological Clinic

Tallahassee, Florida, United States

Site Status

Tampa General/University of South Florida

Tampa, Florida, United States

Site Status

Atlanta VA Medical Center

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Southern Illinois Healthcare

Carbondale, Illinois, United States

Site Status

The University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Northshore University

Evanston, Illinois, United States

Site Status

Northwestern University

Evanston, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Mercy Health Riverside

Rockford, Illinois, United States

Site Status

Prairie Heart/St. John's Hospital

Springfield, Illinois, United States

Site Status

Franciscan St. Francis Health

Indianapolis, Indiana, United States

Site Status

Deaconess Heart Group

Newburgh, Indiana, United States

Site Status

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Baptist Health Lexington

Lexington, Kentucky, United States

Site Status

University of Kentucky Hospital

Lexington, Kentucky, United States

Site Status

University of Louisville Hospital

Louisville, Kentucky, United States

Site Status

Tulane University Heart and Vascular

New Orleans, Louisiana, United States

Site Status

Ochsner Health System

New Orleans, Louisiana, United States

Site Status

Maine Medical Center

Portland, Maine, United States

Site Status

University of Maryland VA

Baltimore, Maryland, United States

Site Status

Johns Hopkins Medical Institution

Baltimore, Maryland, United States

Site Status

White Oak Medical Center

Takoma Park, Maryland, United States

Site Status

St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, United States

Site Status

University of Massachusetts Memorial Hospital

Worcester, Massachusetts, United States

Site Status

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Site Status

University of Michigan Hospital and Health Systems

Ann Arbor, Michigan, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Michigan Vascular Center/McLaren- Flint

Flint, Michigan, United States

Site Status

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Site Status

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

Petoskey, Michigan, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Trinity Health/Michigan Heart

Ypsilanti, Michigan, United States

Site Status

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

Golden Valley, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

St. Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status

Cox Medical Center

Springfield, Missouri, United States

Site Status

Mercy Medical Research Institute

Springfield, Missouri, United States

Site Status

John Cochran VA Medical Center

St Louis, Missouri, United States

Site Status

Mercy Hospital

St Louis, Missouri, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Cooper University

Camden, New Jersey, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

SUNY Buffalo

Buffalo, New York, United States

Site Status

The Feinstein Institute of Medical Research/Northwell Health

Manhasset, New York, United States

Site Status

Mount Sinai Hospital New York

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

St. Francis Hospital

Roslyn, New York, United States

Site Status

Stony Brook University

Stony Brook, New York, United States

Site Status

Crouse Hospital

Syracuse, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

North Carolina Heart & Vascular Research

Raleigh, North Carolina, United States

Site Status

Coastal Carolina Surgical Associates PA

Wilmington, North Carolina, United States

Site Status

Novant Health/Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Sanford Health

Fargo, North Dakota, United States

Site Status

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Ohio State Medical Center

Columbia, Ohio, United States

Site Status

OhioHealth Research Institute

Columbus, Ohio, United States

Site Status

Jobst Vascular Institute/University of Toledo

Toledo, Ohio, United States

Site Status

Mercy Health St. Vincent Medical Center

Toledo, Ohio, United States

Site Status

St. John Clinical Research Institute

Tulsa, Oklahoma, United States

Site Status

Providence Brain and Spine Institute

Portland, Oregon, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Lehigh Valley Hospital - Network Office of Research

Allentown, Pennsylvania, United States

Site Status

UPMC Altoona

Altoona, Pennsylvania, United States

Site Status

Doylestown Hospital

Doylestown, Pennsylvania, United States

Site Status

UPMC Hamot

Erie, Pennsylvania, United States

Site Status

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

UPMC Presbyterian University Hospital

Pittsburgh, Pennsylvania, United States

Site Status

VA Pittsburgh Healthcare

Pittsburgh, Pennsylvania, United States

Site Status

Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, United States

Site Status

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Site Status

Berks Cardiologists / St. Joseph's Medical Center

Wyomissing, Pennsylvania, United States

Site Status

The Miriam Hospital

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

North Central Heart Institute

Sioux Falls, South Dakota, United States

Site Status

CVA Heart Institute

Kingsport, Tennessee, United States

Site Status

Tennova Healthcare/ Turkey Creek Medical Center

Knoxville, Tennessee, United States

Site Status

Baptist Memorial Hospital

Memphis, Tennessee, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Seton Medical Center Austin

Austin, Texas, United States

Site Status

Cardiothoracic and Vascular Surgeons

Austin, Texas, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Valley Baptist Medical Center

Harlingen, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

Memorial Hermann Texas Medical Center

Houston, Texas, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

University of Utah Hospitals and Clinics

Salt Lake City, Utah, United States

Site Status

George E. Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, Utah, United States

Site Status

University of Virginia Health System

Charlottesville, Virginia, United States

Site Status

Inova Fairfax Health Care

Falls Church, Virginia, United States

Site Status

Winchester Medical Center

Winchester, Virginia, United States

Site Status

Overlake Hospital

Bellevue, Washington, United States

Site Status

University of Washington Medicine-Harborview Medical Center

Seattle, Washington, United States

Site Status

VA Puget Sound Health Care System

Seattle, Washington, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

Providence Sacred Heart Medical Center

Spokane, Washington, United States

Site Status

West Virginia University

Morgantown, West Virginia, United States

Site Status

Gundersen Clinic, Ltd

La Crosse, Wisconsin, United States

Site Status

University of Wisconsin Hospitals & Clinics

Madison, Wisconsin, United States

Site Status

Fiona Stanley Hospital

Perth, , Australia

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

St. Boniface Hospital

Winnipeg, Ontario, Canada

Site Status

CHU de Québec/ Hôpital de l'Enfant-Jésus

Québec, Quebec, Canada

Site Status

Soroka University Medical Center

Beersheba, , Israel

Site Status

Soroka University Vascular Surgery

Beersheba, , Israel

Site Status

Rambam Healthcare

Haifa, , Israel

Site Status

Hadassah Medical Center

Jerusalem, , Israel

Site Status

Shaare-Zedek Medical Center

Jerusalem, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

Hospital Clinic Barcelona

Barcelona, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Canada Israel Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36746636 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35713008 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34433306 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34148021 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33071206 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32951538 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31353274 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31303133 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28818255 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28768800 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28462683 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U01NS080168

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-004051

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

TRACER RGD-K5 Carotid Plaque Imaging Study
NCT01968226 TERMINATED PHASE2
Revacept in Symptomatic Carotid Stenosis
NCT01645306 COMPLETED PHASE2