Carotid Revascularization Endarterectomy Versus Stenting Trial

NCT ID: NCT00004732

Last Updated: 2017-05-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2502 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2016-12-31

Brief Summary

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The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the traditional and accepted surgical approach of carotid endarterectomy (CEA) for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).

Detailed Description

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The primary aim of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to contrast the relative effectiveness of carotid artery stenting (CAS) versus carotid endarterectomy (CEA) in preventing stroke, myocardial infarction, and death. Stents are medical devices approved and commonly used for treatment of heart disease. The stent that will be used in this trial is the Rapid Exchange(RX) ACCULINK(TM) Carotid Stent System, an elastic-like metal scaffold that is expanded inside a carotid artery to hold the vessel open.

The RX ACCUNET(TM) Embolic Protection System (an umbrella-like device that expands above the narrowed portion of the carotid artery) will be used in conjunction with the RX ACCULINK stent. The RX ACCUNET system is designed to capture embolic material that could break off from the narrowed area in the carotid artery while still allowing blood to flow through the vessel during the procedure. Embolic material could block blood flow to the arteries beyond the narrowing and be harmful to the brain. The RX ACCUNET System is closed and removed after the stent is placed.

CEA involves a neck incision and physical removal of the plaque from the inside of the artery. CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. The stent is then placed to cover the plaque and hold the artery open. Participants will be randomly assigned to undergo either CAS or CEA, and all patients will receive best medical management, which includes treatment with aspirin, treatment of high blood pressure, and treatment of other stroke risk factors. Participants will be followed for up to ten years.

With the simplification of the protocol for long-term follow-up, the focus for secondary outcomes is to assess restenosis and viability of the procedure. Restenosis rates on an annual basis in both the endarterectomy and stenting arms of the study will be assessed using carotid duplex ultrasound exams performed annually (standard of care).

In addition to restenosis, the "viability" of the procedures will be assessed by the need (or lack of need) for repeat revascularization (either open surgical or endovascular) after the index procedure. The question "has a new carotid intervention been performed since last follow-up" will be asked at every contact with the patient. If answered positively, additional data will be collected on the appropriate case report forms(CRFs).

LINKAGE OF CREST COHORT WITH CENTERS FOR MEDICAID AND MEDICARE SERVICES(CMS) ADMINISTRATIVE DATA

The purpose of linking Medicare-eligible CREST participants with CMS data files is to assess patient outcomes and utilization of health care services. This plan to link in- and out-patient episodes of care using national Medicare data establishes a new resource that will enhance current follow-up strategies, as well as explore alternative strategies to ascertain patient outcomes for future clinical studies.

Conditions

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Atherosclerosis Stroke Carotid Stenosis Cerebral Infarction Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Carotid Artery Endarterectomy (CEA)

Carotid endarterectomy is surgery to remove plaque buildup that causes narrowing (stenosis) in the carotid artery.

Group Type ACTIVE_COMPARATOR

Carotid Endarterectomy (CEA)

Intervention Type PROCEDURE

CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.

Carotid Artery Stenting (CAS)

Carotid artery stenting (CAS) is a procedure used to open narrowed carotid arteries. During the procedure, a small, expandable wire tube called a stent is permanently inserted into the carotid artery.

Group Type ACTIVE_COMPARATOR

Carotid Artery Stenting (CAS)

Intervention Type DEVICE

CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. A stent is then placed to cover the plaque and hold the artery open. Participants randomized to this arm of the trial were treated using the RX Acculink Carotid Stent with or without the RX Accunet Embolic Protection Device.

Interventions

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Carotid Endarterectomy (CEA)

CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.

Intervention Type PROCEDURE

Carotid Artery Stenting (CAS)

CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. A stent is then placed to cover the plaque and hold the artery open. Participants randomized to this arm of the trial were treated using the RX Acculink Carotid Stent with or without the RX Accunet Embolic Protection Device.

Intervention Type DEVICE

Other Intervention Names

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Angioplasty of carotid artery and stent placement.

Eligibility Criteria

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Inclusion Criteria

* Symptomatic patients with recent neurological events (TIA or non-disabling stroke) with an associated carotid stenosis greater than or equal to 50% by angiography or greater than or equal to 70% by ultrasound or greater than or equal to 70% by Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) are eligible for randomization.
* Asymptomatic patients with no recent (in the last 6 months) neurological events referable to the study with artery and carotid stenosis (patients with symptoms beyond 180 days are considered asymptomatic) greater than or equal to 60% by angiography or greater than or equal to 70% by ultrasound or greater than or equal to 80% by CTA or MRA are eligible for randomization.

Exclusion Criteria

* Conditions that: (1) interfere with the evaluation of endpoints, (2) are known to interfere with the completion of CEA or CAS, or (3) affect the likelihood of survival for the study period (4 years). Chronic atrial fibrillation and/or anti-coagulation or episodic atrial fibrillation within the last 6 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas G. Brott, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic and Rutgers University

Locations

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The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Dignity Health dba St. Joseph's Hospital & Medical Center

Phoenix, Arizona, United States

Site Status

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Site Status

The Arizona Board of Regents for the University of Arizona

Tucson, Arizona, United States

Site Status

Board of Trustees of the University of Arkansas

Little Rock, Arkansas, United States

Site Status

USC University Hospital & LA County Hospital

Los Angeles, California, United States

Site Status

The Regents of the University of California

Los Angeles, California, United States

Site Status

Kaiser Permanente Medical Center

San Diego, California, United States

Site Status

Northern California Institute for Research and Education

San Francisco, California, United States

Site Status

Catholic Healthcare West

Stockton, California, United States

Site Status

Christiana Care Health Services, Inc.

Newark, Delaware, United States

Site Status

Morton Plant Hospital

Clearwater, Florida, United States

Site Status

Mayo Clinic

Jacksonville, Florida, United States

Site Status

Leesburg Medical Center

Leesburg, Florida, United States

Site Status

Miami Cardiac & Vascular Institute of Baptist Hospital of Miami, Inc.

Miami, Florida, United States

Site Status

Florida Hospital Neuroscience Institute, a division of Adventist Health System/Sunbelt, Inc.

Orlando, Florida, United States

Site Status

Orlando Regional Medical Center

Orlando, Florida, United States

Site Status

University of South Florida Board of Trustees

Tampa, Florida, United States

Site Status

Piedmont Hospital/Fuqua Heart Center

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

St. Joseph's of Atlanta

Atlanta, Georgia, United States

Site Status

St. Joseph's Candler Health System

Savannah, Georgia, United States

Site Status

Norwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Alexian Brothers Specialty Group

Elk Grove Village, Illinois, United States

Site Status

Loyola University of Chicago

Maywood, Illinois, United States

Site Status

Peoria Radiology Research and Education

Peoria, Illinois, United States

Site Status

Prarie Cardiology-St. John's Hospital

Springfield, Illinois, United States

Site Status

Southern Illinois School of Medicine

Springfield, Illinois, United States

Site Status

Central Dupage Hospital

Winfield, Illinois, United States

Site Status

Lutheran Medical Group, LLC,

Fort Wayne, Indiana, United States

Site Status

Parkview Hospital, Inc.

Fort Wayne, Indiana, United States

Site Status

St. Vincent's Hospital

Indianapolis, Indiana, United States

Site Status

Catholic Health Initiatives /Mercy Hospital Center

Des Moines, Iowa, United States

Site Status

Baptist Healthcare System, Inc.

Lexington, Kentucky, United States

Site Status

Vascular Surgery Associates

Baton Rouge, Louisiana, United States

Site Status

Ochsner Foundation Hospital

New Orleans, Louisiana, United States

Site Status

Anne Arundel Health System Research Institute

Annapolis, Maryland, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Adventist Healthcare, Inc.

Takoma Park, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Steward St. Elizabeth's Medical Center of Boston, Inc.

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Brigham and Womens Hospital, Inc.

Boston, Massachusetts, United States

Site Status

Cape Cod Health Care, Inc.,

Hyannis, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

St. John Hospital and Medical Center

Detroit, Michigan, United States

Site Status

Michigan Vascular Research Center

Flint, Michigan, United States

Site Status

Spectrum Health Hospital

Grand Rapids, Michigan, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Providence St. John Hopital

Southfield, Michigan, United States

Site Status

Michigan Heart & Vascular Institute/St. Joseph's Mercy Hospital

Ypsilanti, Michigan, United States

Site Status

North Memorial Health Care

Robbinsdale, Minnesota, United States

Site Status

Mayo Clinic Rochester/St. Mary's

Rochester, Minnesota, United States

Site Status

Mississippi Baptist Medical Center, Inc.

Jackson, Mississippi, United States

Site Status

Heartland Physician Services, LLC

Kansas City, Missouri, United States

Site Status

Mercy Hospitals East Communities

St Louis, Missouri, United States

Site Status

St. Patrick's Hospital International Heart Institute of MT

Missoula, Montana, United States

Site Status

Dartmouth College and the constituent members of DARTMOUTH HITCHCOCK MEDICAL CENTER

Lebanon, New Hampshire, United States

Site Status

St. Michael's Medical Center

Newark, New Jersey, United States

Site Status

Center for Vascular Awareness, Inc.

Albany, New York, United States

Site Status

Millard Fillmore SUNY Buffalo

Buffalo, New York, United States

Site Status

NYU School of Medicine

New York, New York, United States

Site Status

The Feinstein Institute for Medical Research

New York, New York, United States

Site Status

Weill Medical College of Cornell University

New York, New York, United States

Site Status

Columbia Presbyterian

New York, New York, United States

Site Status

St. Francis Hospital

Port Washington, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Richmond University Medical Center

Staten Island, New York, United States

Site Status

Westchester Medical Center

Valhalla, New York, United States

Site Status

UNC at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

The Charlotte-Mecklenburg Hospital Authority

Charlotte, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Forsyth Radiological Associates

Winston-Salem, North Carolina, United States

Site Status

Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Christ Hospital

Cincinnati, Ohio, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

The Cleveland Clinic Lerner College Of Medicine of CWRU

Cleveland, Ohio, United States

Site Status

Midwest Ohio Health Research Institute

Columbus, Ohio, United States

Site Status

The Toledo Hospital

Toledo, Ohio, United States

Site Status

University of Toledo

Toledo, Ohio, United States

Site Status

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, United States

Site Status

Rogue Valley Medical Center

Medford, Oregon, United States

Site Status

Oregon Health Science University

Portland, Oregon, United States

Site Status

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Site Status

Heritage Valley Medical Group

Beaver, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, United States

Site Status

UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

South Carolina Heart Center

Columbia, South Carolina, United States

Site Status

Metro Knoxville HMA

Knoxville, Tennessee, United States

Site Status

Baptist Memorial Hospital

Memphis, Tennessee, United States

Site Status

The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

UT Houston Memorial

Houston, Texas, United States

Site Status

Scott & White Memorial Hospital

Temple, Texas, United States

Site Status

Intermountain Health Services

Salt Lake City, Utah, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Swedish Health Services

Seattle, Washington, United States

Site Status

Providence Health & Services - Washington

Spokane, Washington, United States

Site Status

Charleston Area Medical Center

Charleston, West Virginia, United States

Site Status

Marshfield Clinic

Marshfield, Wisconsin, United States

Site Status

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Governors of the University of Calgary and the Calgary Health Region

Calgary, Alberta, Canada

Site Status

The University of British Columbia and The Vancouver Coastal Health Authority

Vancouver, British Columbia, Canada

Site Status

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Site Status

The Credit Valley Hospital and Trillium Health Centre

Mississauga, Ontario, Canada

Site Status

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

University Health Network

Toronto, Ontario, Canada

Site Status

Lawson Health Research Institute

Toronto, Ontario, Canada

Site Status

CHU de Québec

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

References

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Hopkins LN, Roubin GS, Chakhtoura EY, Gray WA, Ferguson RD, Katzen BT, Rosenfield K, Goldstein J, Cutlip DE, Morrish W, Lal BK, Sheffet AJ, Tom M, Hughes S, Voeks J, Kathir K, Meschia JF, Hobson RW 2nd, Brott TG. The Carotid Revascularization Endarterectomy versus Stenting Trial: credentialing of interventionalists and final results of lead-in phase. J Stroke Cerebrovasc Dis. 2010 Mar;19(2):153-62. doi: 10.1016/j.jstrokecerebrovasdis.2010.01.001.

Reference Type BACKGROUND
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Howard VJ, Voeks JH, Lutsep HL, Mackey A, Milot G, Sam AD 2nd, Tom M, Hughes SE, Sheffet AJ, Longbottom M, Avery JB, Hobson RW 2nd, Brott TG. Does sex matter? Thirty-day stroke and death rates after carotid artery stenting in women versus men: results from the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) lead-in phase. Stroke. 2009 Apr;40(4):1140-7. doi: 10.1161/STROKEAHA.108.541847. Epub 2009 Feb 10.

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Sheffet AJ, Roubin G, Howard G, Howard V, Moore W, Meschia JF, Hobson RW 2nd, Brott TG. Design of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST). Int J Stroke. 2010 Feb;5(1):40-6. doi: 10.1111/j.1747-4949.2009.00405.x.

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PMID: 20088993 (View on PubMed)

Lal BK, Brott TG. The Carotid Revascularization Endarterectomy vs. Stenting Trial completes randomization: lessons learned and anticipated results. J Vasc Surg. 2009 Nov;50(5):1224-31. doi: 10.1016/j.jvs.2009.09.003.

Reference Type BACKGROUND
PMID: 19878793 (View on PubMed)

Hobson RW 2nd, Brott TG, Roubin GS, Silver FL, Barnett HJ. Carotid artery stenting: meeting the recruitment challenge of a clinical trial. Stroke. 2005 Jun;36(6):1314-5. doi: 10.1161/01.STR.0000165919.26944.05. Epub 2005 Apr 28. No abstract available.

Reference Type BACKGROUND
PMID: 15860747 (View on PubMed)

Hobson RW 2nd, Howard VJ, Roubin GS, Brott TG, Ferguson RD, Popma JJ, Graham DL, Howard G; CREST Investigators. Carotid artery stenting is associated with increased complications in octogenarians: 30-day stroke and death rates in the CREST lead-in phase. J Vasc Surg. 2004 Dec;40(6):1106-11. doi: 10.1016/j.jvs.2004.10.022.

Reference Type BACKGROUND
PMID: 15622363 (View on PubMed)

Hobson RW 2nd, Howard VJ, Roubin GS, Ferguson RD, Brott TG, Howard G, Sheffet AJ, Roberts J, Hopkins LN, Moore WS; CREST. Credentialing of surgeons as interventionalists for carotid artery stenting: experience from the lead-in phase of CREST. J Vasc Surg. 2004 Nov;40(5):952-7. doi: 10.1016/j.jvs.2004.08.039.

Reference Type BACKGROUND
PMID: 15557910 (View on PubMed)

Hobson RW 2nd, Howard VJ, Brott TG, Howard G, Roubin GS, Ferguson RD; For the CREST Executive Committee. Organizing the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): National Institutes of Health, Health Care Financing Administration, and industry funding. Curr Control Trials Cardiovasc Med. 2001 Jul 13;2(4):160-164. doi: 10.1186/cvm-2-4-160.

Reference Type BACKGROUND
PMID: 11806790 (View on PubMed)

Hobson RW 2nd, Brott T, Ferguson R, Roubin G, Moore W, Kuntz R, Howard G, Ferguson J. CREST: carotid revascularization endarterectomy versus stent trial. Cardiovasc Surg. 1997 Oct;5(5):457-8. doi: 10.1016/s0967-2109(97)00048-3. No abstract available.

Reference Type BACKGROUND
PMID: 9464598 (View on PubMed)

Brott TG, Hobson RW 2nd, Howard G, Roubin GS, Clark WM, Brooks W, Mackey A, Hill MD, Leimgruber PP, Sheffet AJ, Howard VJ, Moore WS, Voeks JH, Hopkins LN, Cutlip DE, Cohen DJ, Popma JJ, Ferguson RD, Cohen SN, Blackshear JL, Silver FL, Mohr JP, Lal BK, Meschia JF; CREST Investigators. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010 Jul 1;363(1):11-23. doi: 10.1056/NEJMoa0912321. Epub 2010 May 26.

Reference Type RESULT
PMID: 20505173 (View on PubMed)

Mantese VA, Timaran CH, Chiu D, Begg RJ, Brott TG; CREST Investigators. The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): stenting versus carotid endarterectomy for carotid disease. Stroke. 2010 Oct;41(10 Suppl):S31-4. doi: 10.1161/STROKEAHA.110.595330.

Reference Type RESULT
PMID: 20876500 (View on PubMed)

Silver FL, Mackey A, Clark WM, Brooks W, Timaran CH, Chiu D, Goldstein LB, Meschia JF, Ferguson RD, Moore WS, Howard G, Brott TG; CREST Investigators. Safety of stenting and endarterectomy by symptomatic status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2011 Mar;42(3):675-80. doi: 10.1161/STROKEAHA.110.610212. Epub 2011 Feb 9.

Reference Type RESULT
PMID: 21307169 (View on PubMed)

Blackshear JL, Cutlip DE, Roubin GS, Hill MD, Leimgruber PP, Begg RJ, Cohen DJ, Eidt JF, Narins CR, Prineas RJ, Glasser SP, Voeks JH, Brott TG; CREST Investigators. Myocardial infarction after carotid stenting and endarterectomy: results from the carotid revascularization endarterectomy versus stenting trial. Circulation. 2011 Jun 7;123(22):2571-8. doi: 10.1161/CIRCULATIONAHA.110.008250. Epub 2011 May 23.

Reference Type RESULT
PMID: 21606394 (View on PubMed)

Vilain KR, Magnuson EA, Li H, Clark WM, Begg RJ, Sam AD 2nd, Sternbergh WC 3rd, Weaver FA, Gray WA, Voeks JH, Brott TG, Cohen DJ; CREST Investigators. Costs and cost-effectiveness of carotid stenting versus endarterectomy for patients at standard surgical risk: results from the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2012 Sep;43(9):2408-16. doi: 10.1161/STROKEAHA.112.661355. Epub 2012 Jul 19.

Reference Type RESULT
PMID: 22821614 (View on PubMed)

Lal BK, Beach KW, Roubin GS, Lutsep HL, Moore WS, Malas MB, Chiu D, Gonzales NR, Burke JL, Rinaldi M, Elmore JR, Weaver FA, Narins CR, Foster M, Hodgson KJ, Shepard AD, Meschia JF, Bergelin RO, Voeks JH, Howard G, Brott TG; CREST Investigators. Restenosis after carotid artery stenting and endarterectomy: a secondary analysis of CREST, a randomised controlled trial. Lancet Neurol. 2012 Sep;11(9):755-63. doi: 10.1016/S1474-4422(12)70159-X. Epub 2012 Aug 2.

Reference Type RESULT
PMID: 22857850 (View on PubMed)

Hill MD, Brooks W, Mackey A, Clark WM, Meschia JF, Morrish WF, Mohr JP, Rhodes JD, Popma JJ, Lal BK, Longbottom ME, Voeks JH, Howard G, Brott TG; CREST Investigators. Stroke after carotid stenting and endarterectomy in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). Circulation. 2012 Dec 18;126(25):3054-61. doi: 10.1161/CIRCULATIONAHA.112.120030. Epub 2012 Nov 16.

Reference Type RESULT
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Timaran CH, Mantese VA, Malas M, Brown OW, Lal BK, Moore WS, Voeks JH, Brott TG; CREST Investigators. Differential outcomes of carotid stenting and endarterectomy performed exclusively by vascular surgeons in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). J Vasc Surg. 2013 Feb;57(2):303-8. doi: 10.1016/j.jvs.2012.09.014. Epub 2012 Dec 20.

Reference Type RESULT
PMID: 23265585 (View on PubMed)

Matsumura JS, Hanlon BM, Rosenfield K, Voeks JH, Howard G, Roubin GS, Brott TG. Treatment of carotid stenosis in asymptomatic, nonoctogenarian, standard risk patients with stenting versus endarterectomy trials. J Vasc Surg. 2022 Apr;75(4):1276-1283.e1. doi: 10.1016/j.jvs.2021.10.020. Epub 2021 Oct 22.

Reference Type DERIVED
PMID: 34695552 (View on PubMed)

Howard VJ, Algra A, Howard G, Bonati LH, de Borst GJ, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Greving JP, Halliday A, Hendrikse J, Jansen O, Brown MM, Mas JL, Ringleb PA, Brott TG; Carotid Stenosis Trialists' Collaboration. Absence of Consistent Sex Differences in Outcomes From Symptomatic Carotid Endarterectomy and Stenting Randomized Trials. Stroke. 2021 Jan;52(2):416-423. doi: 10.1161/STROKEAHA.120.030184. Epub 2021 Jan 25.

Reference Type DERIVED
PMID: 33493046 (View on PubMed)

Muller MD, von Felten S, Algra A, Becquemin JP, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Halliday A, Hendrikse J, Howard G, Gregson J, Jansen O, Brown MM, Mas JL, Brott TG, Ringleb PA, Bonati LH. Secular Trends in Procedural Stroke or Death Risks of Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis. Circ Cardiovasc Interv. 2019 Aug;12(8):e007870. doi: 10.1161/CIRCINTERVENTIONS.119.007870. Epub 2019 Aug 5.

Reference Type DERIVED
PMID: 31378071 (View on PubMed)

Moore WS, Voeks JH, Roubin GS, Clark WM, Howard VJ, Jones MR, Brott TG; CREST Investigators. Duration of asymptomatic status and outcomes following carotid endarterectomy and carotid artery stenting in the Carotid Revascularization Endarterectomy vs Stenting Trial. J Vasc Surg. 2019 Jun;69(6):1797-1800. doi: 10.1016/j.jvs.2018.09.054. Epub 2019 Jan 8.

Reference Type DERIVED
PMID: 30630649 (View on PubMed)

Jones MR, Howard G, Roubin GS, Blackshear JL, Cohen DJ, Cutlip DE, Leimgruber PP, Rhodes D, Prineas RJ, Glasser SP, Lal BK, Voeks JH, Brott TG; CREST Investigators. Periprocedural Stroke and Myocardial Infarction as Risks for Long-Term Mortality in CREST. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004663. doi: 10.1161/CIRCOUTCOMES.117.004663.

Reference Type DERIVED
PMID: 30571337 (View on PubMed)

Lal BK, Roubin GS, Jones M, Clark W, Mackey A, Hill MD, Voeks JH, Howard G, Hobson RW 2nd, Brott TG. Influence of multiple stents on periprocedural stroke after carotid artery stenting in the Carotid Revascularization Endarterectomy versus Stent Trial (CREST). J Vasc Surg. 2019 Mar;69(3):800-806. doi: 10.1016/j.jvs.2018.06.221. Epub 2018 Dec 4.

Reference Type DERIVED
PMID: 30527940 (View on PubMed)

Muller MD, von Felten S, Algra A, Becquemin JP, Brown M, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Halliday A, Hendrikse J, Gregson J, Howard G, Jansen O, Mas JL, Brott TG, Ringleb PA, Bonati LH; Carotid Stenosis Trialists' Collaboration. Immediate and Delayed Procedural Stroke or Death in Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis. Stroke. 2018 Nov;49(11):2715-2722. doi: 10.1161/STROKEAHA.118.020684.

Reference Type DERIVED
PMID: 30355202 (View on PubMed)

Sheffet AJ, Howard G, Sam A, Jamil Z, Weaver F, Chiu D, Voeks JH, Howard VJ, Hughes SE, Flaxman L, Longbottom ME, Brott TG; CREST Investigators. Challenge and Yield of Enrolling Racially and Ethnically Diverse Patient Populations in Low Event Rate Clinical Trials. Stroke. 2018 Jan;49(1):84-89. doi: 10.1161/STROKEAHA.117.018063. Epub 2017 Nov 30.

Reference Type DERIVED
PMID: 29191852 (View on PubMed)

Rantner B, Kollerits B, Roubin GS, Ringleb PA, Jansen O, Howard G, Hendrikse J, Halliday A, Gregson J, Eckstein HH, Calvet D, Bulbulia R, Bonati LH, Becquemin JP, Algra A, Brown MM, Mas JL, Brott TG, Fraedrich G; Carotid Stenosis Trialists' Collaboration. Early Endarterectomy Carries a Lower Procedural Risk Than Early Stenting in Patients With Symptomatic Stenosis of the Internal Carotid Artery: Results From 4 Randomized Controlled Trials. Stroke. 2017 Jun;48(6):1580-1587. doi: 10.1161/STROKEAHA.116.016233. Epub 2017 Apr 28.

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PMID: 28455318 (View on PubMed)

Brott TG, Howard G, Roubin GS, Meschia JF, Mackey A, Brooks W, Moore WS, Hill MD, Mantese VA, Clark WM, Timaran CH, Heck D, Leimgruber PP, Sheffet AJ, Howard VJ, Chaturvedi S, Lal BK, Voeks JH, Hobson RW 2nd; CREST Investigators. Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis. N Engl J Med. 2016 Mar 17;374(11):1021-31. doi: 10.1056/NEJMoa1505215. Epub 2016 Feb 18.

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PMID: 26890472 (View on PubMed)

Moore WS, Popma JJ, Roubin GS, Voeks JH, Cutlip DE, Jones M, Howard G, Brott TG; CREST Investigators. Carotid angiographic characteristics in the CREST trial were major contributors to periprocedural stroke and death differences between carotid artery stenting and carotid endarterectomy. J Vasc Surg. 2016 Apr;63(4):851-7, 858.e1. doi: 10.1016/j.jvs.2015.08.119. Epub 2015 Nov 21.

Reference Type DERIVED
PMID: 26610643 (View on PubMed)

Meschia JF, Hopkins LN, Altafullah I, Wechsler LR, Stotts G, Gonzales NR, Voeks JH, Howard G, Brott TG. Time From Symptoms to Carotid Endarterectomy or Stenting and Perioperative Risk. Stroke. 2015 Dec;46(12):3540-2. doi: 10.1161/STROKEAHA.115.011123. Epub 2015 Oct 22.

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PMID: 26493675 (View on PubMed)

Voeks JH, Howard G, Roubin G, Farb R, Heck D, Logan W, Longbottom M, Sheffet A, Meschia JF, Brott TG. Mediators of the Age Effect in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2015 Oct;46(10):2868-73. doi: 10.1161/STROKEAHA.115.009516. Epub 2015 Sep 8.

Reference Type DERIVED
PMID: 26351359 (View on PubMed)

Howard G, Hopkins LN, Moore WS, Katzen BT, Chakhtoura E, Morrish WF, Ferguson RD, Hye RJ, Shawl FA, Harrigan MR, Voeks JH, Howard VJ, Lal BK, Meschia JF, Brott TG. Temporal Changes in Periprocedural Events in the Carotid Revascularization Endarterectomy Versus Stenting Trial. Stroke. 2015 Aug;46(8):2183-9. doi: 10.1161/STROKEAHA.115.008898. Epub 2015 Jul 14.

Reference Type DERIVED
PMID: 26173731 (View on PubMed)

Sheffet AJ, Voeks JH, Mackey A, Brooks W, Clark WM, Hill MD, Howard VJ, Hughes SE, Tom M, Longbottom ME, Brott TG; CREST Investigators. Characteristics of participants consenting versus declining follow-up for up to 10 years in a randomized clinical trial. Clin Trials. 2015 Dec;12(6):657-63. doi: 10.1177/1740774515590807. Epub 2015 Jun 29.

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PMID: 26122922 (View on PubMed)

Malas M, Glebova NO, Hughes SE, Voeks JH, Qazi U, Moore WS, Lal BK, Howard G, Llinas R, Brott TG. Effect of patching on reducing restenosis in the carotid revascularization endarterectomy versus stenting trial. Stroke. 2015 Mar;46(3):757-61. doi: 10.1161/STROKEAHA.114.007634. Epub 2015 Jan 22.

Reference Type DERIVED
PMID: 25613307 (View on PubMed)

Meschia JF, Voeks JH, Leimgruber PP, Mantese VA, Timaran CH, Chiu D, Demaerschalk BM, Howard VJ, Hughes SE, Longbottom M, Howard AG, Brott TG. Management of vascular risk factors in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). J Am Heart Assoc. 2014 Nov 26;3(6):e001180. doi: 10.1161/JAHA.114.001180.

Reference Type DERIVED
PMID: 25428209 (View on PubMed)

Gonzales NR, Demaerschalk BM, Voeks JH, Tom M, Howard G, Sheffet AJ, Garcia L, Clair DG, Barr J, Orlow S, Brott TG; CREST Investigators. Complication rates and center enrollment volume in the carotid revascularization endarterectomy versus stenting trial. Stroke. 2014 Nov;45(11):3320-4. doi: 10.1161/STROKEAHA.114.006228. Epub 2014 Sep 25.

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PMID: 25256180 (View on PubMed)

Howard G, Voeks JH, Meschia JF, Howard VJ, Brott TG. Picking the good apples: statistics versus good judgment in choosing stent operators for a multicenter clinical trial. Stroke. 2014 Nov;45(11):3325-9. doi: 10.1161/STROKEAHA.114.006807. Epub 2014 Sep 11.

Reference Type DERIVED
PMID: 25213339 (View on PubMed)

Sheffet AJ, Flaxman L, Tom M, Hughes SE, Longbottom ME, Howard VJ, Marler JR, Brott TG; CREST Investigators. Financial management of a large multisite randomized clinical trial. Int J Stroke. 2014 Aug;9(6):811-3. doi: 10.1111/ijs.12259. Epub 2014 Mar 24.

Reference Type DERIVED
PMID: 24661748 (View on PubMed)

Zierler RE, Beach KW, Bergelin RO, Lal BK, Moore WS, Roubin GS, Voeks JH, Brott TG; CREST Investigators. Agreement between site-reported and ultrasound core laboratory results for duplex ultrasound velocity measurements in the Carotid Revascularization Endarterectomy versus Stenting Trial. J Vasc Surg. 2014 Jan;59(1):2-7. doi: 10.1016/j.jvs.2013.06.071. Epub 2013 Sep 19.

Reference Type DERIVED
PMID: 24055515 (View on PubMed)

Habersberger J, Brott TG, Roubin GS. Carotid artery stenting: a clinical update. Curr Opin Cardiol. 2012 Nov;27(6):565-71. doi: 10.1097/HCO.0b013e3283587506.

Reference Type DERIVED
PMID: 22941123 (View on PubMed)

Voeks JH, Howard G, Roubin GS, Malas MB, Cohen DJ, Sternbergh WC 3rd, Aronow HD, Eskandari MK, Sheffet AJ, Lal BK, Meschia JF, Brott TG; CREST Investigators. Age and outcomes after carotid stenting and endarterectomy: the carotid revascularization endarterectomy versus stenting trial. Stroke. 2011 Dec;42(12):3484-90. doi: 10.1161/STROKEAHA.111.624155. Epub 2011 Oct 6.

Reference Type DERIVED
PMID: 21980205 (View on PubMed)

Cohen DJ, Stolker JM, Wang K, Magnuson EA, Clark WM, Demaerschalk BM, Sam AD Jr, Elmore JR, Weaver FA, Aronow HD, Goldstein LB, Roubin GS, Howard G, Brott TG; CREST Investigators. Health-related quality of life after carotid stenting versus carotid endarterectomy: results from CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial). J Am Coll Cardiol. 2011 Oct 4;58(15):1557-65. doi: 10.1016/j.jacc.2011.05.054.

Reference Type DERIVED
PMID: 21958882 (View on PubMed)

Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7.

Reference Type DERIVED
PMID: 21899409 (View on PubMed)

Howard VJ, Lutsep HL, Mackey A, Demaerschalk BM, Sam AD 2nd, Gonzales NR, Sheffet AJ, Voeks JH, Meschia JF, Brott TG; CREST investigators. Influence of sex on outcomes of stenting versus endarterectomy: a subgroup analysis of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). Lancet Neurol. 2011 Jun;10(6):530-7. doi: 10.1016/S1474-4422(11)70080-1. Epub 2011 May 5.

Reference Type DERIVED
PMID: 21550314 (View on PubMed)

Other Identifiers

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

R01NS038384

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0119970017

Identifier Type: -

Identifier Source: org_study_id

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