Carotid Revascularization Endarterectomy Versus Stenting Trial
- Conditions
- StrokeMyocardial InfarctionAtherosclerosisCarotid StenosisCerebral Infarction
- Interventions
- Procedure: Carotid Endarterectomy (CEA)Device: Carotid Artery Stenting (CAS)
- Registration Number
- NCT00004732
- Lead Sponsor
- Rutgers, The State University of New Jersey
- Brief 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 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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2502
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carotid Artery Endarterectomy (CEA) Carotid Endarterectomy (CEA) Carotid endarterectomy is surgery to remove plaque buildup that causes narrowing (stenosis) in the carotid artery. Carotid Artery Stenting (CAS) 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.
- Primary Outcome Measures
Name Time Method Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years. 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.
- Secondary Outcome Measures
Name Time Method 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 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.
Trial Locations
- Locations (115)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Piedmont Hospital/Fuqua Heart Center
🇺🇸Atlanta, Georgia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
St. Joseph's of Atlanta
🇺🇸Atlanta, Georgia, United States
USC University Hospital & LA County Hospital
🇺🇸Los Angeles, California, United States
Norwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Midwest Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Allegheny Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
The Cleveland Clinic Lerner College Of Medicine of CWRU
🇺🇸Cleveland, Ohio, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Steward St. Elizabeth's Medical Center of Boston, Inc.
🇺🇸Boston, Massachusetts, United States
St. Vincent's Hospital
🇺🇸Indianapolis, Indiana, United States
Kaiser Permanente Medical Center
🇺🇸San Diego, California, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Northern California Institute for Research and Education
🇺🇸San Francisco, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Dignity Health dba St. Joseph's Hospital & Medical Center
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Oklahoma Foundation for Cardiovascular Research
🇺🇸Oklahoma City, Oklahoma, United States
The Regents of the University of California
🇺🇸Los Angeles, California, United States
The Arizona Board of Regents for the University of Arizona
🇺🇸Tucson, Arizona, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Board of Trustees of the University of Arkansas
🇺🇸Little Rock, Arkansas, United States
Leesburg Medical Center
🇺🇸Leesburg, Florida, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Central Dupage Hospital
🇺🇸Winfield, Illinois, United States
Catholic Health Initiatives /Mercy Hospital Center
🇺🇸Des Moines, Iowa, United States
Parkview Hospital, Inc.
🇺🇸Fort Wayne, Indiana, United States
Miami Cardiac & Vascular Institute of Baptist Hospital of Miami, Inc.
🇺🇸Miami, Florida, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Vascular Surgery Associates
🇺🇸Baton Rouge, Louisiana, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Anne Arundel Health System Research Institute
🇺🇸Annapolis, Maryland, United States
Peoria Radiology Research and Education
🇺🇸Peoria, Illinois, United States
Lutheran Medical Group, LLC,
🇺🇸Fort Wayne, Indiana, United States
Prarie Cardiology-St. John's Hospital
🇺🇸Springfield, Illinois, United States
St. Joseph's Candler Health System
🇺🇸Savannah, Georgia, United States
Loyola University of Chicago
🇺🇸Maywood, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Alexian Brothers Specialty Group
🇺🇸Elk Grove Village, Illinois, United States
Southern Illinois School of Medicine
🇺🇸Springfield, Illinois, United States
Cape Cod Health Care, Inc.,
🇺🇸Hyannis, Massachusetts, United States
Michigan Vascular Research Center
🇺🇸Flint, Michigan, United States
St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Baptist Healthcare System, Inc.
🇺🇸Lexington, Kentucky, United States
Millard Fillmore SUNY Buffalo
🇺🇸Buffalo, New York, United States
Providence St. John Hopital
🇺🇸Southfield, Michigan, United States
North Memorial Health Care
🇺🇸Robbinsdale, Minnesota, United States
Richmond University Medical Center
🇺🇸Staten Island, New York, United States
Dartmouth College and the constituent members of DARTMOUTH HITCHCOCK MEDICAL CENTER
🇺🇸Lebanon, New Hampshire, United States
Mississippi Baptist Medical Center, Inc.
🇺🇸Jackson, Mississippi, United States
Spectrum Health Hospital
🇺🇸Grand Rapids, Michigan, United States
Mercy Hospitals East Communities
🇺🇸St. Louis, Missouri, United States
St. Michael's Medical Center
🇺🇸Newark, New Jersey, United States
Brigham and Womens Hospital, Inc.
🇺🇸Boston, Massachusetts, United States
Michigan Heart & Vascular Institute/St. Joseph's Mercy Hospital
🇺🇸Ypsilanti, Michigan, United States
The Feinstein Institute for Medical Research
🇺🇸New York, New York, United States
Columbia Presbyterian
🇺🇸New York, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
St. Francis Hospital
🇺🇸Port Washington, New York, United States
NYU School of Medicine
🇺🇸New York, New York, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
The Charlotte-Mecklenburg Hospital Authority
🇺🇸Charlotte, North Carolina, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
The Toledo Hospital
🇺🇸Toledo, Ohio, United States
University of Toledo
🇺🇸Toledo, Ohio, United States
Rogue Valley Medical Center
🇺🇸Medford, Oregon, United States
UT Houston Memorial
🇺🇸Houston, Texas, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
South Carolina Heart Center
🇺🇸Columbia, South Carolina, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Lawson Health Research Institute
🇨🇦Toronto, Ontario, Canada
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Governors of the University of Calgary and the Calgary Health Region
🇨🇦Calgary, Alberta, Canada
The University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada
The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Mayo Clinic Rochester/St. Mary's
🇺🇸Rochester, Minnesota, United States
Oregon Health Science University
🇺🇸Portland, Oregon, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
University of South Florida Board of Trustees
🇺🇸Tampa, Florida, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Presbyterian Shadyside
🇺🇸Pittsburgh, Pennsylvania, United States
Florida Hospital Neuroscience Institute, a division of Adventist Health System/Sunbelt, Inc.
🇺🇸Orlando, Florida, United States
Orlando Regional Medical Center
🇺🇸Orlando, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Forsyth Radiological Associates
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Catholic Healthcare West
🇺🇸Stockton, California, United States
Center for Vascular Awareness, Inc.
🇺🇸Albany, New York, United States
Heritage Valley Medical Group
🇺🇸Beaver, Pennsylvania, United States
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
Intermountain Health Services
🇺🇸Salt Lake City, Utah, United States
Swedish Health Services
🇺🇸Seattle, Washington, United States
Providence Health & Services - Washington
🇺🇸Spokane, Washington, United States
The Credit Valley Hospital and Trillium Health Centre
🇨🇦Mississauga, Ontario, Canada
Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
CHU de Québec
🇨🇦Quebec City, Quebec, Canada
Metro Knoxville HMA
🇺🇸Knoxville, Tennessee, United States
Christiana Care Health Services, Inc.
🇺🇸Newark, Delaware, United States
University of Rochester
🇺🇸Rochester, New York, United States
St. Patrick's Hospital International Heart Institute of MT
🇺🇸Missoula, Montana, United States
The University of British Columbia and The Vancouver Coastal Health Authority
🇨🇦Vancouver, British Columbia, Canada
Ochsner Foundation Hospital
🇺🇸New Orleans, Louisiana, United States
Adventist Healthcare, Inc.
🇺🇸Takoma Park, Maryland, United States
Heartland Physician Services, LLC
🇺🇸Kansas City, Missouri, United States
UNC at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States