Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

April 13, 2017 updated by: Rutgers, The State University of New Jersey

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2502

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Governors of the University of Calgary and the Calgary Health Region
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3J5
        • The University of British Columbia and The Vancouver Coastal Health Authority
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H2A6
        • St. Boniface General Hospital
    • Ontario
      • Mississauga, Ontario, Canada, L5B 4A2
        • The Credit Valley Hospital and Trillium Health Centre
      • Ottawa, Ontario, Canada, K1H1A2
        • Ottawa Hospital Research Institute
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5T 2S8
        • University Health Network
      • Toronto, Ontario, Canada, N6A5A5
        • Lawson Health Research Institute
    • Quebec
      • Quebec City, Quebec, Canada, G1J1Z4
        • Chu De Quebec
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Dignity Health dba St. Joseph's Hospital & Medical Center
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona
      • Tucson, Arizona, United States, 85724
        • The Arizona Board of Regents for the University of Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72701
        • Board of Trustees of the University of Arkansas
    • California
      • Los Angeles, California, United States, 90095
        • The Regents of the University of California
      • Los Angeles, California, United States, 90033
        • USC University Hospital & LA County Hospital
      • San Diego, California, United States, 92120
        • Kaiser Permanente Medical Center
      • San Francisco, California, United States, 94121
        • Northern California Institute for Research and Education
      • Stockton, California, United States, 95204
        • Catholic Healthcare West
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health Services, Inc.
    • Florida
      • Clearwater, Florida, United States, 33756
        • Morton Plant Hospital
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Leesburg, Florida, United States, 34748
        • Leesburg Medical Center
      • Miami, Florida, United States, 33187
        • Miami Cardiac & Vascular Institute of Baptist Hospital of Miami, Inc.
      • Orlando, Florida, United States, 32803
        • Florida Hospital Neuroscience Institute, a division of Adventist Health System/Sunbelt, Inc.
      • Orlando, Florida, United States, 32828
        • Orlando Regional Medical Center
      • Tampa, Florida, United States, 33606
        • University of South Florida Board of Trustees
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital/Fuqua Heart Center
      • Atlanta, Georgia, United States, 30342
        • St. Joseph's of Atlanta
      • Savannah, Georgia, United States, 31405
        • St. Joseph's Candler Health System
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Norwestern Memorial Hospital
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Specialty Group
      • Maywood, Illinois, United States, 60153
        • Loyola University of Chicago
      • Peoria, Illinois, United States, 61637
        • Peoria Radiology Research and Education
      • Springfield, Illinois, United States, 62794
        • Prarie Cardiology-St. John's Hospital
      • Springfield, Illinois, United States, 62794
        • Southern Illinois School of Medicine
      • Winfield, Illinois, United States, 60190
        • Central DuPage Hospital
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Parkview Hospital, Inc.
      • Fort Wayne, Indiana, United States, 46804
        • Lutheran Medical Group, LLC,
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent's Hospital
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Catholic Health Initiatives /Mercy Hospital Center
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Baptist Healthcare System, Inc.
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Vascular Surgery Associates
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Foundation Hospital
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Health System Research Institute
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
      • Takoma Park, Maryland, United States, 20912
        • Adventist Healthcare, Inc.
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02135
        • Steward St. Elizabeth's Medical Center of Boston, Inc.
      • Boston, Massachusetts, United States, 02215
        • Brigham and Womens Hospital, Inc.
      • Hyannis, Massachusetts, United States, 02601
        • Cape Cod Health Care, Inc.,
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Detroit, Michigan, United States, 48236
        • St. John Hospital and Medical Center
      • Flint, Michigan, United States, 48507
        • Michigan Vascular Research Center
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Hospital
      • Royal Oak, Michigan, United States, 48075
        • William Beaumont Hospital
      • Southfield, Michigan, United States, 48075
        • Providence St. John Hopital
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart & Vascular Institute/St. Joseph's Mercy Hospital
    • Minnesota
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Health Care
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester/St. Mary's
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Mississippi Baptist Medical Center, Inc.
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Heartland Physician Services, LLC
      • St. Louis, Missouri, United States, 63141
        • Mercy Hospitals East Communities
    • Montana
      • Missoula, Montana, United States, 59802
        • St. Patrick's Hospital International Heart Institute of MT
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth College and the constituent members of DARTMOUTH HITCHCOCK MEDICAL CENTER
    • New Jersey
      • Newark, New Jersey, United States, 07013
        • St. Michael's Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Center for Vascular Awareness, Inc.
      • Buffalo, New York, United States, 14209
        • Millard Fillmore SUNY Buffalo
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
      • New York, New York, United States, 10016
        • NYU School of Medicine
      • New York, New York, United States, 10021
        • The Feinstein Institute for Medical Research
      • New York, New York, United States, 10032
        • Columbia Presbyterian
      • Port Washington, New York, United States, 11050
        • St. Francis Hospital
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Staten Island, New York, United States, 10310
        • Richmond University Medical Center
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC at Chapel Hill
      • Charlotte, North Carolina, United States, 28203
        • The Charlotte-Mecklenburg Hospital Authority
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Radiological Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cincinnati, Ohio, United States, 45219
        • Christ Hospital
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Lerner College Of Medicine of CWRU
      • Columbus, Ohio, United States, 43214
        • Midwest Ohio Health Research Institute
      • Toledo, Ohio, United States, 43614
        • University of Toledo
      • Toledo, Ohio, United States, 43606
        • The Toledo Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Foundation for Cardiovascular Research
    • Oregon
      • Medford, Oregon, United States, 97504
        • Rogue Valley Medical Center
      • Portland, Oregon, United States, 97201
        • Oregon Health Science University
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Lehigh Valley Hospital
      • Beaver, Pennsylvania, United States, 15009
        • Heritage Valley Medical Group
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Singer Research Institute
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Presbyterian Shadyside
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • South Carolina Heart Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Metro Knoxville HMA
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • The University of Texas Southwestern Medical Center at Dallas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030
        • UT Houston Memorial
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • Intermountain Health Services
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Health Services
      • Spokane, Washington, United States, 99204
        • Providence Health & Services - Washington
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Carotid Artery Endarterectomy (CEA)
Carotid endarterectomy is surgery to remove plaque buildup that causes narrowing (stenosis) in the carotid artery.
Procedure: Carotid Endarterectomy (CEA)
CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
ACTIVE_COMPARATOR: 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.
Device: 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.
Other Names:
  • Angioplasty of carotid artery and stent placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
30 days and 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 4 years
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.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

University of Alabama at Birmingham
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Thomas G. Brott, M.D., Mayo Clinic and Rutgers University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

February 25, 2000

First Submitted That Met QC Criteria

February 25, 2000

First Posted (ESTIMATE)

February 28, 2000

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0119970017
  • R01NS038384 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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