Lumbar Canal Stenosis |
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Clinical Trial: Stenting vs. Surgery to Prevent Stroke
This study is currently recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| Stroke Cerebral Infarction Carotid Stenosis Atherosclerosis | Procedure: carotid endarterectomy Procedure: carotid angioplasty with stenting | Phase III |
MedlinePlus related topics: Carotid Artery Disease; Stroke; Vascular Diseases
Study Type: Interventional
Study Design: Prevention, Randomized
Official Title: Carotid Revascularization Endarterectomy versus Stenting Trial (CREST)
Study start: December 2000
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 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 four years.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Symptomatic patients with recent neurological events (TIA or non-disabling stroke) with an associated carotid stenosis greater than 50% by angiography or greater than 70% by ultrasound 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 60% by angiography or greater than 70% by ultrasound 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.
Location and Contact Information
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States; Recruiting
William D. Jordan, Principal Investigator
Arizona
Barrow Neurological Institute--St. Joseph's Hospital, Phoenix, Arizona, 85013, United States; Recruiting
Robert F. Spetzler, MD, Principal Investigator
University of Arizona, Tucson, Arizona, United States; Recruiting
Joseph Mills, MD, Principal Investigator
California
USC University Hospital & LA County Hospital, Los Angeles, California, 90033, United States; Recruiting
Fred Weaver, MD, Principal Investigator
UCLA, Los Angeles, California, 90095, United States; Recruiting
Kathleen Walden kgwalden@mednet.ucla.edu
Wes Moore, MD, Principal Investigator
Kaiser Permanente Medical Center, San Diego, California, 92120, United States; Recruiting
Susan Barron 619-528-5503 susan.j.barron@kp.org
Robert J. Hye, MD, Principal Investigator
St. Joseph's Medical Center, Stockton, California, 95204, United States; Recruiting
Hooman Madyoon, MD, Principal Investigator
Delaware
Christiana Health Care, Newark, Delaware, 19718, United States; Not yet recruiting
John Shuck, Principal Investigator
Florida
Orlando Regional Medical Center, Orlando, Florida, 32828, United States; Recruiting
Joseph G. Andriole, MD, Principal Investigator
Miami Cardiac & Vascular Institute, Miami, Florida, 33187, United States; Recruiting
Barry Katzen, MD, Principal Investigator
Mayo Clinic--Jacksonville, Jacksonville, Florida, 32224, United States; Recruiting
Albert G. Hakaim, MD, Principal Investigator
USF Tampa General Hospital, Tampa, Florida, 33606, United States; Recruiting
Dennis Bandyk, MD, Principal Investigator
Florida Hospital, Orlando, Florida, 32803, United States; Not yet recruiting
Frank Huang-Hellinger, MD, Principal Investigator
Georgia
Emory University, Atlanta, Georgia, 30322, United States; Recruiting
Elliot Chaikof, MD, Principal Investigator
St. Joseph's Candler Health System, Savannah, Georgia, 31405, United States; Not yet recruiting
Jay Howington, MD, Principal Investigator
Memorial Health University Medical Center, Savannah, Georgia, 31405, United States; Recruiting
Jay Howington, MD, Principal Investigator
Illinois
Norwestern Memorial Hospital, Chicago, Illinois, 60611, United States; Recruiting
Mark Eskandari, MD, Principal Investigator
Prarie Cardiology-St. John's Hospital, Springfield, Illinois, 62794, United States; Recruiting
Gregory Mishkel, MD, Principal Investigator
Southern Illinois School of Medicine, Springfield, Illinois, 62794, United States; Recruiting
Kim J. Hodgson, MD, Principal Investigator
Loyola University Medical Center, Maywood, Illinois, 60153, United States; Recruiting
Jose Biller, MD, Principal Investigator
Rush University Medical Center, Chicago, Illinois, 60612, United States; Recruiting
Jeffrey R. Snell, MD, Principal Investigator
Peoria Radiology Research and Education, Peoria, Illinois, 61637, United States; Recruiting
Ken Fraser, M.D., Principal Investigator
Alexian Brothers Medical Center, Elkgrove, Illinois, 60007, United States; Not yet recruiting
Sarah Johnson, MD, Principal Investigator
Indiana
Parkview Hospital, Fort Wayne, Indiana, 46805, United States; Recruiting
Hollace Chastain, MD, Principal Investigator
Indiana University, Indianapolis, Indiana, 46202, United States; Not yet recruiting
Steven Willing, MD, Principal Investigator
St. Vincent's Hospital, Indianapolis, Indiana, 46260, United States; Not yet recruiting
Katherine Krol, MD, Principal Investigator
Lutheran Hospital of Indiana, Fort Wayne, Indiana, 46804, United States; Recruiting
Steven Orlow, MD, Principal Investigator
Iowa
Iowa Heart Center/Mercy Hospital Center, Des Moines, Iowa, 50314, United States; Recruiting
L. A. Iannone, MD, Principal Investigator
Kentucky
Central Baptist Hospital, Lexington, Kentucky, 40504, United States; Recruiting
William Brooks, Principal Investigator
Louisiana
Ochsner Foundation Hospital, New Orleans, Louisiana, 70121, United States; Recruiting
Robert Felberg, MD, Principal Investigator
Terrebonne General Medical Center, Houma, Louisiana, 70360, United States; Not yet recruiting
Peter Fall, MD, Principal Investigator
Vascular Surgery Associates, Baton Rouge, Louisiana, 70809, United States; Not yet recruiting
Albert Sam, MD, Principal Investigator
Maryland
Washington Adventist Hospital, Takoma Park, Maryland, 20912, United States; Recruiting
Fayaz Shawl, MD, Principal Investigator
Anne Arundel Medical Center, Annapolis, Maryland, 21401, United States; Not yet recruiting
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Frank LoGerfo, Principal Investigator
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States; Recruiting
Kenneth Rosenfield, MD, Principal Investigator
Cape Cod Hospital, Hyannis, Massachusetts, 02601, United States; Recruiting
Richard Zelman, MD, Principal Investigator
St. Elizabeth's Medical Center, Boston, Massachusetts, 02135, United States; Recruiting
Peter A. Soukas, M.D., Principal Investigator
Brigham and Womens Hospital, Boston, Massachusetts, 02215, United States; Recruiting
Michael Belkin, M.D., Principal Investigator
Michigan
William Beaumont Hospital, Royal Oak, Michigan, 48075, United States; Recruiting
O. William Brown, MD, Principal Investigator
St. John Hospital and Medical Center, Detroit, Michigan, 48236, United States; Recruiting
Thomas Davis, MD, Principal Investigator
Harper University Hospital, Detroit, Michigan, 48201, United States; Not yet recruiting
Thomas Davis, MD, Principal Investigator
Henry Ford Hospital, Detroit, Michigan, 48202, United States; Not yet recruiting
Daniel Reddy, MD, Principal Investigator
Butterworth Hospital, Grand Rapids, Michigan, 49503, United States; Recruiting
Ashraf Mansour, MD, Principal Investigator
Michigan Vascular Research Center, Flint, Michigan, 48507, United States; Recruiting
Robert Molnar, MD, Principal Investigator
Minnesota
Mayo Clinic Rochester/St. Mary's, Rochester, Minnesota, 55905, United States; Recruiting
Harry Cloft, MD, Principal Investigator
North Memorial Health Care, Robbinsdale, Minnesota, 55422, United States; Recruiting
Irfan Altafullah, Principal Investigator
Missouri
St. Luke's Hospital, Kansas City, Missouri, 64110, United States; Recruiting
Steven Laster, MD, Principal Investigator
Washington University/St. Louis/Barnes Jewish, St. Louis, Missouri, 63110, United States; Not yet recruiting
Gregorio A. Sicard, MD, Principal Investigator
Montana
St. Patrick's Hospital International Heart Institute of MT, Missoula, Montana, 59802, United States; Not yet recruiting
Mark Sanz, MD, Principal Investigator
New Hampshire
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States; Not yet recruiting
Richard Powell, MD, Principal Investigator
New Jersey
St. Michael's Medical Center, Newark, New Jersey, 07013, United States; Recruiting
Zafar Jamil, MD, Principal Investigator
New York
St. Francis Hospital--Long Island Surgical Specialists, Port Washington, New York, 11050, United States; Recruiting
Renato B. Berroya, MD, Principal Investigator
Cornell Medical Center, New York, New York, 10021, United States; Recruiting
Pierre Gobin, MD, Principal Investigator
Columbia Presbyterian, New York, New York, 10032, United States; Recruiting
J. P. Mohr, MD, Principal Investigator
Millard Fillmore SUNY Buffalo, Buffalo, New York, 14209, United States; Recruiting
Mary Hartney mhartney@buffins.org
L. Nelson Hopkins, MD, Principal Investigator
Albany Medical Center Hospital, Albany, New York, 12208, United States; Recruiting
Manish Mehta, MD, Principal Investigator
University of Rochester/Strong Memorial, Rochester, New York, 14642, United States; Recruiting
Craig Narins, MD, Principal Investigator
Westchester Medical Center, Valhalla, New York, 10595, United States; Recruiting
Anthony Pucillo, MD, Principal Investigator
New York University Medical Center, New York, New York, 10016, United States; Recruiting
Neal Cayne, M.D., Principal Investigator
Lenox Hill Hospital, New York, New York, 10021, United States; Recruiting
Gary Roubin, MD, Principal Investigator
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States; Recruiting
Tony P. Smith, MD, Principal Investigator
Carolinas Medical Center/Sanger Clinic, Charlotte, North Carolina, 28203, United States; Recruiting
Michael Rinaldi, MD, Principal Investigator
UNC at Chapel Hill, Chapel Hill, North Carolina, 27599, United States; Recruiting
Walter Tan, MD, Principal Investigator
Wake Forest University, Winston Salem, North Carolina, 27157, United States; Recruiting
Juan Ayerdi, MD, Principal Investigator
Ohio
Cleveland Clinic, Cleveland, Ohio, 44195, United States; Recruiting
Daniel Clair, MD, Principal Investigator
Midwest Cardiology/Grant Riverside Methodist Hospital, Columbus, Ohio, 43214, United States; Recruiting
Gary Ansel, MD, Principal Investigator
University of Cincinnati, Cincinnati, Ohio, 45267, United States; Recruiting
Andrew Ringer, Principal Investigator
Medical College of Ohio, Cincinnati, Ohio, 46314, United States; Not yet recruiting
Munier Nazzal, MD, Principal Investigator
The Toledo Hospital, Toledo, Ohio, 43606, United States; Recruiting
John Pigott, MD, Principal Investigator
Oregon
Oregon Health Science University, Portland, Oregon, 97201, United States; Recruiting
Wayne M. Clark, MD, Principal Investigator
Rogue Valley Medical Center, Medford, Oregon, 97504, United States; Recruiting
Kent Dauterman, MD, Principal Investigator
Pennsylvania
UPENN, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Michael Golden, MD, Principal Investigator
UPMC/Shadyside Hospital and Presbyterian Hospital, Pittsburgh, Pennsylvania, 15232, United States; Recruiting
Sharon Decesares 412-647-4998 decesares@upmc.edu
Lawrence Wechsler, Principal Investigator
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, 19107, United States; Recruiting
Robert H. Rosenwasser, MD, Principal Investigator
Geisinger Medical Center, Danville, Pennsylvania, 17822, United States; Recruiting
James Elmore, Principal Investigator
Tri-State Medical Center, Beaver, Pennsylvania, 15009, United States; Not yet recruiting
Richard Begg, MD, Principal Investigator
Lehigh Valley Hospital, Allentown, Pennsylvania, 18105, United States; Not yet recruiting
Bryan Kluck, MD, Principal Investigator
Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02903, United States; Not yet recruiting
Timothy Murphy, MD, Principal Investigator
Tennessee
Baptist Hospital East Tennessee, Knoxville, Tennessee, 37920, United States; Recruiting
Malcolm Foster, MD, Principal Investigator
Baptist Memorial Hospital, Memphis, Tennessee, 38120, United States; Not yet recruiting
John D. Barr, MD, Principal Investigator
Texas
UT Health Sciences Center--Houston, Houston, Texas, 77030, United States; Recruiting
John Choi, Principal Investigator
UT Health Science Center at San Antonio, San Antonio, Texas, 78284, United States; Not yet recruiting
Michael Wholey, MD, Principal Investigator
Methodist Hospital, Houston, Texas, 77030, United States; Recruiting
David Chiu, MD, Principal Investigator
Utah
LDS Hospital, Salt Lake City, Utah, 84143, United States; Recruiting
Sherman Sorenson, MD, Principal Investigator
Washington
Swedish Heart Institute, Seattle, Washington, 98122, United States; Recruiting
William Gray, MD, Principal Investigator
Deaconess Medical Center, Spokane, Washington, 99204, United States; Recruiting
Pierre Leimgruber, Principal Investigator
Sacred Heart Medical Center, Spokane, Washington, 99220, United States; Recruiting
Rodney D. Raabe, MD, Principal Investigator
West Virginia
Charleston Area Medical Center, Charleston, West Virginia, 25304, United States; Recruiting
Mark Bates, MD, Principal Investigator
Wisconsin
Marshfield Clinic, Marshfield, Wisconsin, 54449, United States; Recruiting
Percy Karanjia, MD, Principal Investigator
St. Luke's Medical Center, Milwaukee, Wisconsin, 53215, United States; Not yet recruiting
Tanvir Bajwa, MD, Principal Investigator
Canada, Alberta
Foothills Hospital, Calgary, Alberta, T2N 2T9, Canada; Recruiting
Michael Hill, MD, Principal Investigator
University of Alberta, Edmonton, Alberta, T7G2B7, Canada; Not yet recruiting
Derek Emory, MD, Principal Investigator
Canada, British Columbia
Vancouver General Hospital, Vancouver, British Columbia, V5Z 3J5, Canada; Not yet recruiting
Phil Teal, MD, Principal Investigator
Canada, Manitoba
St. Boniface General Hospital, Winnipeg, Manitoba, R2H2A6, Canada; Recruiting
Randy Guzman, MD, Principal Investigator
Canada, Ontario
Toronto Western Hospital, Toronto, Ontario, M5T 2S8, Canada; Recruiting
Walter Montanera, Principal Investigator
Trillium Health Centre, Mississauga, Ontario, L5B 4A2, Canada; Not yet recruiting
Daniel Selchen, M.D., Principal Investigator
London Health Science Centre, Toronto, Ontario, N6A5A5, Canada; Not yet recruiting
David Pelz, MD, Principal Investigator
Canada, Quebec
Hospital L'Enfant Jesu, Quebec City, Quebec, G1J1Z4, Canada; Recruiting
Ariane Mackey, MD, Principal Investigator
Robert W. Hobson, II, M.D., Principal Investigator, University of Medicine and Dentistry of New Jersey
More Information
CREST study website
Record last reviewed: March 2005
Last Updated: March 22, 2005
Record first received: February 25, 2000
ClinicalTrials.gov Identifier: NCT00004732
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Lumbar Canal Stenosis (Cleveland Clinic)
- Lumbar Canal Stenosis (Cleveland Clinic)

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