|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Medicine and Dentistry New Jersey |
|---|---|
| Collaborator: |
National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00004732 |
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 |
|---|---|---|
|
Stroke Cerebral Infarction Carotid Stenosis Atherosclerosis |
Procedure: carotid endarterectomy Procedure: carotid angioplasty with stenting |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Parallel Assignment |
| Official Title: | Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) |
| Estimated Enrollment: | 2500 |
| Study Start Date: | December 2000 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Procedure: carotid endarterectomy
CEA involves a neck incision and physical removal of the plaque from the inside of the artery.
|
| 2: Active Comparator |
Procedure: carotid angioplasty with stenting
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.
|
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 older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study 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 | |
| University of Arizona | |
| Tucson, Arizona, United States, 85724 | |
| Mayo Clinic Arizona | |
| Scottsdale, Arizona, United States, 85259 | |
| 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 | |
| St. Joseph's Medical Center | |
| Stockton, California, United States, 95204 | |
| San Francisco VA Medical Center | |
| San Francisco, California, United States, 94121 | |
| United States, Delaware | |
| Christiana Health Care | |
| Newark, Delaware, United States, 19718 | |
| United States, Florida | |
| USF Tampa General Hospital | |
| Tampa, Florida, United States, 33606 | |
| 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 | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| Morton Plant Hospital | |
| Clearwater, Florida, United States, 33756 | |
| Leesburg Medical Center | |
| Leesburg, Florida, United States, 34748 | |
| United States, Georgia | |
| Piedmont Hospital/Fuqua Heart Center | |
| Atlanta, Georgia, United States, 30309 | |
| St. Joseph's Candler Health System | |
| Savannah, Georgia, United States, 31405 | |
| St. Joseph's of Atlanta | |
| Atlanta, Georgia, United States, 30342 | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Central Dupage Hospital | |
| Winfield, Illinois, United States, 60190 | |
| Prarie Cardiology-St. John's Hospital | |
| Springfield, Illinois, United States, 62794 | |
| Southern Illinois School of Medicine | |
| Springfield, Illinois, United States, 62794 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Peoria Radiology Research and Education | |
| Peoria, Illinois, United States, 61637 | |
| Alexian Brothers Medical Center | |
| Elk Grove Village, Illinois, United States, 60007 | |
| Norwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Parkview Hospital | |
| Fort Wayne, Indiana, United States, 46805 | |
| St. Vincent's Hospital | |
| Indianapolis, Indiana, United States, 46260 | |
| Lutheran Hospital of Indiana | |
| Fort Wayne, Indiana, United States, 46804 | |
| 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 | |
| Ochsner Foundation Hospital | |
| New Orleans, Louisiana, United States, 70121 | |
| Vascular Surgery Associates | |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Maryland | |
| Washington Adventist Hospital | |
| Takoma Park, Maryland, United States, 20912 | |
| Anne Arundel Medical Center | |
| Annapolis, Maryland, United States, 21401 | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Brigham and Womens Hospital | |
| Boston, Massachusetts, United States, 02215 | |
| St. Elizabeth's Medical Center | |
| Boston, Massachusetts, United States, 02135 | |
| Cape Cod Hospital | |
| Hyannis, Massachusetts, United States, 02601 | |
| United States, Michigan | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48075 | |
| St. John Hospital and Medical Center | |
| Detroit, Michigan, United States, 48236 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Butterworth Hospital | |
| Grand Rapids, Michigan, United States, 49503 | |
| Michigan Heart & Vascular Institute/St. Joseph's Mercy Hospital | |
| Ypsilanti, Michigan, United States, 48197 | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| Michigan Vascular Research Center | |
| Flint, Michigan, United States, 48507 | |
| Providence St. John Hopital | |
| Southfield, Michigan, United States, 48075 | |
| United States, Minnesota | |
| Mayo Clinic Rochester/St. Mary's | |
| Rochester, Minnesota, United States, 55905 | |
| North Memorial Health Care | |
| Robbinsdale, Minnesota, United States, 55422 | |
| 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 | |
| St. Francis Hospital--Long Island Surgical Specialists | |
| Port Washington, New York, United States, 11050 | |
| Cornell Medical Center | |
| New York, New York, United States, 10021 | |
| University of Rochester/Strong Memorial | |
| Rochester, New York, United States, 14642 | |
| Millard Fillmore SUNY Buffalo | |
| Buffalo, New York, United States, 14209 | |
| Albany Medical Center Hospital | |
| Albany, New York, United States, 12208 | |
| Columbia Presbyterian | |
| New York, New York, United States, 10032 | |
| Westchester Medical Center | |
| Valhalla, New York, United States, 10595 | |
| NYU School of Medicine | |
| New York, New York, United States, 10016 | |
| Lenox Hill Hospital | |
| New York, New York, United States, 10021 | |
| Richmond University Medical Center | |
| Staten Island, New York, United States, 10310 | |
| 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 | |
| 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 | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267 | |
| Christ Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Oklahoma | |
| Oklahoma Foundation for Cardiovascular Research | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, Oregon | |
| Oregon Health Science University | |
| Portland, Oregon, United States, 97201 | |
| Rogue Valley Medical Center | |
| Medford, Oregon, United States, 97504 | |
| United States, Pennsylvania | |
| Thomas Jefferson University Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| UPMC/Shadyside Hospital and Presbyterian Hospital | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| UPENN | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| Tri-State Medical Center | |
| Beaver, Pennsylvania, United States, 15009 | |
| Lehigh Valley Hospital | |
| Allentown, Pennsylvania, United States, 18105 | |
| 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 | |
| UT Houston Memorial | |
| Houston, Texas, United States, 77030 | |
| Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| University of Texas-Southwestern | |
| Dallas, Texas, United States, 75390 | |
| Scott & White Memorial Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| LDS Hospital | |
| 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 | |
| Toronto Western Hospital | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Trillium Health Centre | |
| Mississauga, Ontario, Canada, L5B 4A2 | |
| London Health Science Centre | |
| Toronto, Ontario, Canada, N6A5A5 | |
| Ottawa Hospital | |
| Ottawa, Ontario, Canada, K1H1A2 | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Canada, Quebec | |
| Hospital L'Enfant Jesu | |
| Quebec City, Quebec, Canada, G1J1Z4 | |
| Principal Investigator: | Thomas G. Brott, M.D. | Mayo Clinic and University of Medicine and Dentistry New Jersey |
More Information
| Responsible Party: | Mayo Clinic and University of Medicine and Dentistry New Jersey ( Thomas G. Brott, MD, Principal Investigator ) |
| Study ID Numbers: | 0119970017 |
| Study First Received: | February 25, 2000 |
| Last Updated: | August 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004732 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
surgery stenting CREST Stroke Cerebral Infarction carotid endarterectomy |
carotid stenting revascularization angioplasty stenosis atherosclerosis |
|
Atherosclerosis Arterial Occlusive Diseases Cerebral Infarction Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases Ischemia Arteriosclerosis Brain Diseases |
Cerebrovascular Disorders Carotid Stenosis Necrosis Pathologic Processes Brain Ischemia Cardiovascular Diseases Brain Infarction Infarction Carotid Artery Diseases |
