Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Alabama at Birmingham
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00004732
First received: February 25, 2000
Last updated: January 4, 2016
Last verified: October 2015
  Purpose
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).

Condition Intervention Phase
Atherosclerosis
Stroke
Carotid Stenosis
Cerebral Infarction
Myocardial Infarction
Procedure: Carotid Endarterectomy (CEA)
Device: Carotid Artery Stenting (CAS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 2502
Study Start Date: December 2000
Estimated Study Completion Date: December 2016
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Angioplasty of carotid artery and stent placement.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004732

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

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00004732     History of Changes
Other Study ID Numbers: 0119970017  R01NS038384 
Study First Received: February 25, 2000
Results First Received: September 26, 2013
Last Updated: January 4, 2016
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board
Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
angioplasty
asymptomatic
atherosclerosis
carotid endarterectomy
carotid stenting
CREST
Cerebral Infarction
device
intervention
restenosis
revascularization
stenosis
stent
stroke
symptomatic
surgery
transient ischemic attack

Additional relevant MeSH terms:
Atherosclerosis
Carotid Stenosis
Cerebral Infarction
Infarction
Myocardial Infarction
Arterial Occlusive Diseases
Arteriosclerosis
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Stroke
Vascular Diseases

ClinicalTrials.gov processed this record on May 30, 2016