AzTrials
AzTrials

AtherosclerosisCRESTNCT00004732

Carotid Revascularization Endarterectomy Versus Stenting Trial

A study testing Carotid Endarterectomy (CEA) and Carotid Artery Stenting (CAS) in people with Atherosclerosis and Stroke, run by Rutgers, The State University of New Jersey at 115 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atherosclerosis, Stroke, Carotid Stenosis
What is being tested?
Carotid Endarterectomy (CEA) and Carotid Artery Stenting (CAS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,502 participants
Where
115 sitesin 2 countries
Study dates
Dec 2000to Dec 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

115 sites in 2 countries.

115 sites in 2 countries

United States106 sites

  • Center for Vascular Awareness, Inc.

    Albany, New York, 12208

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Anne Arundel Health System Research Institute

    Annapolis, Maryland, 21401

  • Piedmont Hospital/Fuqua Heart Center

    Atlanta, Georgia, 30309

  • Emory University

    Atlanta, Georgia, 30322

  • St. Joseph's of Atlanta

    Atlanta, Georgia, 30342

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Vascular Surgery Associates

    Baton Rouge, Louisiana, 70809

  • Heritage Valley Medical Group

    Beaver, Pennsylvania, 15009

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

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

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

    Boston, Massachusetts, 02135

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Brigham and Womens Hospital, Inc.

    Boston, Massachusetts, 02215

  • Millard Fillmore SUNY Buffalo

    Buffalo, New York, 14209

  • UNC at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

  • The Charlotte-Mecklenburg Hospital Authority

    Charlotte, North Carolina, 28203

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Norwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • The Cleveland Clinic Lerner College Of Medicine of CWRU

    Cleveland, Ohio, 44195

  • South Carolina Heart Center

    Columbia, South Carolina, 29204

  • Midwest Ohio Health Research Institute

    Columbus, Ohio, 43214

  • The University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Catholic Health Initiatives /Mercy Hospital Center

    Des Moines, Iowa, 50314

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Alexian Brothers Specialty Group

    Elk Grove Village, Illinois, 60007

  • Michigan Vascular Research Center

    Flint, Michigan, 48507

  • Lutheran Medical Group, LLC,

    Fort Wayne, Indiana, 46804

  • Parkview Hospital, Inc.

    Fort Wayne, Indiana, 46805

  • Spectrum Health Hospital

    Grand Rapids, Michigan, 49503

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • UT Houston Memorial

    Houston, Texas, 77030

  • Cape Cod Health Care, Inc.,

    Hyannis, Massachusetts, 02601

  • St. Vincent's Hospital

    Indianapolis, Indiana, 46260

  • Mississippi Baptist Medical Center, Inc.

    Jackson, Mississippi, 39202

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Heartland Physician Services, LLC

    Kansas City, Missouri, 64114

  • Metro Knoxville HMA

    Knoxville, Tennessee, 37920

  • Dartmouth College and the constituent members of DARTMOUTH HITCHCOCK MEDICAL CENTER

    Lebanon, New Hampshire, 03756

  • Leesburg Medical Center

    Leesburg, Florida, 34748

  • Baptist Healthcare System, Inc.

    Lexington, Kentucky, 40504

  • Board of Trustees of the University of Arkansas

    Little Rock, Arkansas, 72701

  • USC University Hospital & LA County Hospital

    Los Angeles, California, 90033

  • The Regents of the University of California

    Los Angeles, California, 90095

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Loyola University of Chicago

    Maywood, Illinois, 60153

  • Rogue Valley Medical Center

    Medford, Oregon, 97504

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

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

    Miami, Florida, 33187

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • St. Patrick's Hospital International Heart Institute of MT

    Missoula, Montana, 59802

  • Ochsner Foundation Hospital

    New Orleans, Louisiana, 70121

  • NYU School of Medicine

    New York, New York, 10016

  • The Feinstein Institute for Medical Research

    New York, New York, 10021

  • Weill Medical College of Cornell University

    New York, New York, 10021

  • Columbia Presbyterian

    New York, New York, 10032

  • Christiana Care Health Services, Inc.

    Newark, Delaware, 19718

  • St. Michael's Medical Center

    Newark, New Jersey, 07013

  • Oklahoma Foundation for Cardiovascular Research

    Oklahoma City, Oklahoma, 73120

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

    Orlando, Florida, 32803

  • Orlando Regional Medical Center

    Orlando, Florida, 32828

  • Peoria Radiology Research and Education

    Peoria, Illinois, 61637

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

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

    Phoenix, Arizona, 85013

  • Allegheny Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • UPMC Presbyterian Shadyside

    Pittsburgh, Pennsylvania, 15232

  • St. Francis Hospital

    Port Washington, New York, 11050

  • Oregon Health Science University

    Portland, Oregon, 97201

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • North Memorial Health Care

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic Rochester/St. Mary's

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • William Beaumont Hospital

    Royal Oak, Michigan, 48075

  • Intermountain Health Services

    Salt Lake City, Utah, 84143

  • Kaiser Permanente Medical Center

    San Diego, California, 92120

  • Northern California Institute for Research and Education

    San Francisco, California, 94121

  • St. Joseph's Candler Health System

    Savannah, Georgia, 31405

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Swedish Health Services

    Seattle, Washington, 98122

  • Providence St. John Hopital

    Southfield, Michigan, 48075

  • Providence Health & Services - Washington

    Spokane, Washington, 99204

  • Prarie Cardiology-St. John's Hospital

    Springfield, Illinois, 62794

  • Southern Illinois School of Medicine

    Springfield, Illinois, 62794

  • Mercy Hospitals East Communities

    St Louis, Missouri, 63141

  • Richmond University Medical Center

    Staten Island, New York, 10310

  • Catholic Healthcare West

    Stockton, California, 95204

  • Adventist Healthcare, Inc.

    Takoma Park, Maryland, 20912

  • University of South Florida Board of Trustees

    Tampa, Florida, 33606

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • The Toledo Hospital

    Toledo, Ohio, 43606

  • University of Toledo

    Toledo, Ohio, 43614

  • The Arizona Board of Regents for the University of Arizona

    Tucson, Arizona, 85724

  • Westchester Medical Center

    Valhalla, New York, 10595

  • Central Dupage Hospital

    Winfield, Illinois, 60190

  • Forsyth Radiological Associates

    Winston-Salem, North Carolina, 27103

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

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

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada9 sites

  • Governors of the University of Calgary and the Calgary Health Region

    Calgary, Alberta, T2N 2T9

  • The Credit Valley Hospital and Trillium Health Centre

    Mississauga, Ontario, L5B 4A2

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H1A2

  • CHU de Québec

    Québec, Quebec, G1J1Z4

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • University Health Network

    Toronto, Ontario, M5T 2S8

  • Lawson Health Research Institute

    Toronto, Ontario, N6A5A5

  • The University of British Columbia and The Vancouver Coastal Health Authority

    Vancouver, British Columbia, V5Z 3J5

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H2A6

Other trials in Canada

About this study

Official title: Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

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).

Read the detailed description

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.

Being tested
Carotid Endarterectomy (CEA), Carotid Artery Stenting (CAS)
Keywords
angioplasty, asymptomatic, atherosclerosis, carotid endarterectomy, carotid stenting, CREST, Cerebral Infarction, device, intervention, restenosis, revascularization, stenosis, stent, stroke, symptomatic, surgery, transient ischemic attack
Medical subject headings
Atherosclerosis, Stroke, Carotid Stenosis, Cerebral Infarction, Myocardial Infarction, Constriction, Pathologic, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carotid Endarterectomy (CEA)Procedure or surgery

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

  • Carotid Artery Stenting (CAS)Device

    Also called Angioplasty of carotid artery and stent placement.

    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.

Study groups in NCT00004732
Study groupRoleWhat they receive
Carotid Artery Endarterectomy (CEA)Active comparatorCarotid endarterectomy is surgery to remove plaque buildup that causes narrowing (stenosis) in the carotid artery.
Receives: Procedure: Carotid Endarterectomy (CEA)
Carotid Artery Stenting (CAS)Active comparatorCarotid 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.
Receives: Device: Carotid Artery Stenting (CAS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years.

    The primary aim of CREST is to assess if the efficacy of CAS differs from that of CEA in preventing stroke, myocardial infarction and death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period in patients with symptomatic (>=50%) or asymptomatic (>=60%) extracranial carotid stenosis. Four-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.

    Measured: 30 days and 4 years

Secondary outcomes (1)

  1. Differential Efficacy of CAS and CEA in Male and Female Participants in the Primary Endpoint (Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke).

    4-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2000 (estimated)
  2. Study startDec 2000
  3. Primary completionFeb 2011
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
2,502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004732
Sponsor's protocol ID
0119970017
Other IDs
R01NS038384
Acronym
CREST
Status last verified
Apr 2017
First submitted
25 Feb 2000
Last updated
17 May 2017
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 20189092

  • 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.

    PubMed 19211486

  • 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.

    PubMed 20088993

  • 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.

    PubMed 19878793

  • 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.

    PubMed 15860747

  • 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.

    PubMed 15622363

  • 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.

    PubMed 15557910

  • 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.

    PubMed 11806790

  • 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: 10.1177/096721099700500504. No abstract available.

    PubMed 9464598

  • 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.

    PubMed 20505173

  • 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.

    PubMed 20876500

  • 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.

    PubMed 21307169

  • 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.

    PubMed 21606394

  • 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.

    PubMed 22821614

  • 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.

    PubMed 22857850

Questions about this trial

What is this clinical trial studying?

A study testing Carotid Endarterectomy (CEA) and Carotid Artery Stenting (CAS) in people with Atherosclerosis and Stroke, run by Rutgers, The State University of New Jersey at 115 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years. (time frame: 30 days and 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00004732, which also lists 43 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017; AzTrials last refreshed its copy on 4 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in