Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Alabama at Birmingham
Rutgers, The State University of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00004732
First received: February 25, 2000
Last updated: March 14, 2014
Last verified: September 2013
  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
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
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Barrow Neurological Institute--St. Joseph's Hospital
Phoenix, Arizona, United States, 85013
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
University of Arizona
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States, 72701
United States, California
USC University Hospital & LA County Hospital
Los Angeles, California, United States, 90033
UCLA
Los Angeles, California, United States, 90095
Kaiser Permanente Medical Center
San Diego, California, United States, 92120
San Francisco VA Medical Center
San Francisco, California, United States, 94121
St. Joseph's Medical Center
Stockton, California, United States, 95204
United States, Delaware
Christiana Health Care
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
Baptist Cardiac & Vascular Institute
Miami, Florida, United States, 33187
Orlando Regional Medical Center
Orlando, Florida, United States, 32828
Florida Hospital
Orlando, Florida, United States, 32803
USF Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
St. Joseph's of Atlanta
Atlanta, Georgia, United States, 30342
Piedmont Hospital/Fuqua Heart Center
Atlanta, Georgia, United States, 30309
St. Joseph's Candler Health System
Savannah, Georgia, United States, 31405
United States, Illinois
Norwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Peoria Radiology Research and Education
Peoria, Illinois, United States, 61637
Southern Illinois School of Medicine
Springfield, Illinois, United States, 62794
Prarie Cardiology-St. John's Hospital
Springfield, Illinois, United States, 62794
Central Dupage Hospital
Winfield, Illinois, United States, 60190
United States, Indiana
Parkview Hospital
Fort Wayne, Indiana, United States, 46805
Lutheran Hospital of Indiana
Fort Wayne, Indiana, United States, 46804
St. Vincent's Hospital
Indianapolis, Indiana, United States, 46260
United States, Iowa
Iowa Heart Center/Mercy Hospital Center
Des Moines, Iowa, United States, 50314
United States, Kentucky
Central Baptist Hospital
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 Medical Center
Annapolis, Maryland, United States, 21401
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02215
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Michigan Vascular Research Center
Flint, Michigan, United States, 48507
Butterworth 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
Jackson, Mississippi, United States, 39202
United States, Missouri
St. Joseph's KC
Kansas City, Missouri, United States, 64114
St. John Mercy Medical Center
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 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
Albany Medical Center Hospital
Albany, New York, United States, 12208
Millard Fillmore SUNY Buffalo
Buffalo, New York, United States, 14209
Lenox Hill Hospital
New York, New York, United States, 10021
Columbia Presbyterian
New York, New York, United States, 10032
NYU School of Medicine
New York, New York, United States, 10016
Cornell Medical Center
New York, New York, United States, 10021
St. Francis Hospital--Long Island Surgical Specialists
Port Washington, New York, United States, 11050
University of Rochester/Strong Memorial
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
Carolinas Medical Center/Sanger Clinic
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 Medical Center
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
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Midwest Cardiology/Grant Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
The Toledo Hospital
Toledo, Ohio, United States, 43606
University of Toledo Medical Center
Toledo, Ohio, United States, 43614
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 Health System
Beaver, Pennsylvania, United States, 15009
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
UPENN
Philadelphia, Pennsylvania, United States, 19104
UPMC/Shadyside Hospital and Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15232
Allegheny General
Pittsburgh, Pennsylvania, United States, 15212
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
Baptist Hospital East Tennessee
Knoxville, Tennessee, United States, 37920
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
United States, Texas
University of Texas-Southwestern
Dallas, Texas, United States, 75390
UT Houston Memorial
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
Scott & White Memorial Hospital
Temple, Texas, United States, 76508
United States, Utah
Intermountain Health
Salt Lake City, Utah, United States, 84143
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Swedish Heart Institute
Seattle, Washington, United States, 98122
Deaconess Medical Center
Spokane, Washington, United States, 99204
Providence Medical Research Center
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
Foothills Hospital
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 3J5
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R2H2A6
Canada, Ontario
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 4A2
Ottawa Hospital
Ottawa, Ontario, Canada, K1H1A2
London Health Science Centre
Toronto, Ontario, Canada, N6A5A5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Hospital L'Enfant Jesus
Quebec City, Quebec, Canada, G1J1Z4
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
University of Alabama at Birmingham
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Thomas G. Brott, M.D. Mayo Clinic and Rutgers University
  More Information

Additional Information:
Publications:

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

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry 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: March 14, 2014
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Institutional Review Board
Canada: Health Canada

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
Stroke
Constriction, Pathologic
Infarction
Myocardial Infarction
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia
Pathological Conditions, Anatomical
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases

ClinicalTrials.gov processed this record on July 20, 2014