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Home > "S" Clinical Trials Conditions > Stenting vs. Surgery to Prevent Stroke  Stenting vs. Surgery to Prevent Stroke
Stenting vs. Surgery to Prevent Stroke
For Condition: Atherosclerosis,Stroke,Cerebral Infarction,Carotid Stenosis
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: 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.
Details: The primary aim of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to contrast the relative effectiveness of carotid angioplasty with stenting (CAS) versus carotid endarterectomy (CEA) in preventing stroke, myocardial infarction, and death. Patients will be followed for up to four years. CAS is a relatively new procedure that has increased in popularity in recent years due in part to advances in stent technology. Stents are medical devices approved and commonly used for treatment of heart disease. The investigational 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 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 ACCULINK stent. The 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 ACCUNET System is closed and removed after the stent is placed. Many interventionalists believe that CAS has advantages over CEA because CAS is less invasive. 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. A balloon dilates the artery and the stent is then placed to cover the plaque and hold the artery open. Even though both procedures provide benefits to patients, no studies have shown conclusively which procedure, stenting or surgery, is better overall. Patients 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.
Eligibility:
Study Type: Interventional, Prevention, Randomized
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 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).
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertHobson, Principal Investigator, University of Medicine and Dentistry of New Jersey
Cape Cod Hospital *Recruiting*
Hyannis, Massachusetts, 02601
United States
Recruiting Lizbeth Shea 508-957-7248
New York University Medical Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Ronnie Landis 212-263-7710
Mercy Hospital Center *Recruiting*
Des Moines, Iowa, 50314
United States
Recruiting Rochelle Porter 515-235-5114
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Debbie O'Shaughnessy 617-726-3057
UT Health Science Center at San Antonio *Not yet recruiting*
San Antonio, Texas, 78284
United States
Not yet recruiting Carmen Young 210-567-3760
Sacred Heart Medical Center *Recruiting*
Spokane, Washington, 99220
United States
Recruiting Lynn Dahlstrom 509-625-3028
Marshfield Clinic *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Kathy Mancl 715-389-3748
Mayo Clinic Rochester/St. Mary's *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Leigh Gray 507-255-4377
Norwestern Memorial Hospital *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Wendy Meadows 312-695-2928
University of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting Dell Day 205-934-7279
Oregon Health Science University *Recruiting*
Portland, Oregon, 97201
United States
Recruiting Anne Doherty 503-494-7224
Thomas Jefferson University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting Maureen Jensen 215-503-5739
Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Lourdes Norwick 708-216-2057
Sanger Clinic *Recruiting*
Charlotte, North Carolina, 28203
United States
Recruiting Gale Schwarz 704-355-4794
Rush University Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Jason Daily 312-942-8144
Deaconess Medical Center *Recruiting*
Spokane, Washington, 99204
United States
Recruiting Jason Krauss 509-473-3492
Orlando Regional Healthcare *Recruiting*
Orlando, Florida, 32828
United States
Recruiting Lucia Lilien 321-841-8101
Mayo Clinic--Jacksonville *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Diana Partin 904-953-8736
UPENN *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Kathy Riese 215-662-2058
Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Betty Ship 404-778-3164
Trillium Health Centre *Recruiting*
Mississauga, Ontario, L5B 4A2
Canada
Recruiting Heather Hink 905-848-7367
Grant Riverside Methodist Hospital *Recruiting*
Columbus, Ohio, 43214
United States
Recruiting Beth Weirick 614-263-1011
North Memorial Health Care *Recruiting*
Robbinsdale, Minnesota, 55422
United States
Recruiting Krista Miller 763-302-4069
William Beaumont Hospital *Recruiting*
Southfield, Michigan, 48075
United States
Recruiting Brian Walker 248-551-7930
USC University Hospital & LA County Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Joy Hunt 323-442-5752
Kaiser Permanente Medical Center *Recruiting*
San Diego, California, 92120
United States
Recruiting Sonni Longson 619-528-5503
Peoria Radiology Research and Education *Recruiting*
Peoria, Illinois, 61637
United States
Recruiting J. Vrabel 309-655-7653
Parkview Hospital *Recruiting*
Ft. Wayne, Indiana, 46805
United States
Recruiting Jeanne Carroll 260-373-8175
USF Tampa General Hospital *Recruiting*
Tampa, Florida, 33606
United States
Recruiting Jaime Parker 813-259-0683
Caritas St. Elizabeth's Hospital *Recruiting*
Boston, Massachusetts, 02135
United States
Recruiting Laura Kenney 617-789-2841
Westchester Medical Center *Recruiting*
Valhalla, New York, 10595
United States
Recruiting Jean Baruth 914-493-5324
Cornell Medical Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Kimberly Scott 212-746-4998
Southern Illinois School of Medicine *Recruiting*
Springfield, Illinois, 62794
United States
Recruiting Carol Buettner 217-545-2320
Columbia Presbyterian *Recruiting*
New York City, New York, 10032
United States
Recruiting Leslie Schmidt 212-342-0551
Montefiore Medical Center *Recruiting*
Bronx, New York, 10467
United States
Recruiting Jamie McKay 718-920-7329
Foothills Hospital *Recruiting*
Calgary, Alberta, T2N 2T9
Canada
Recruiting Marie McClelland 403-944-4347
Methodist Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting David McCane 713-798-6225
University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Deborah Schofield 410-328-7490
East Tennessee Baptist Hospital *Recruiting*
Knoxville, Tennessee, 37920
United States
Recruiting Beth Polk 865-549-7535
University of Cincinnati *Recruiting*
Cincinnati, Ohio, 45267
United States
Recruiting Suzanne Kempisty-Cliver 513-558-5387
Indiana University *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Alison Sears 317-278-1976
Geisinger Medical Center *Recruiting*
Danville, Pennsylvania, 17822
United States
Recruiting Al Griffin 570-271-6866
UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Candace Vescera 310-206-1115
Miami Cardiac & Vascular Institute *Recruiting*
Miami, Florida, 33187
United States
Recruiting Sarah Orendorff-Alegre 305-596-1960
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Jennifer Lambert 617-632-9962
St. Francis Hospital--Long Island Surgical Specialists *Recruiting*
Port Washington, New York, 11050
United States
Recruiting Elizabeth Haag 516-562-6790
Prarie Cardiology-St. John's Hospital *Recruiting*
Springfield, Illinois, 62794
United States
Recruiting Nancy Staten 217-544-6464
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Joanna Stoner 919-668-5275
Brigham and Womens Hospital *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Lisamarie Fahy 617-732-4778
UT Health Sciences Center--Houston *Recruiting*
Houston, Texas, 77030
United States
Recruiting Carol Underwood 713-500-6563
St. John Hospital and Medical Center *Recruiting*
Detroit, Michigan, 48236
United States
Recruiting Teresa Ingle 313-343-8335
Washington University/St. Louis/Barnes Jewish *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Christine Keller 314-362-6290
Albany Medical Center Hospital *Recruiting*
Albany, New York, 12208
United States
Recruiting Linda Graca 518-262-5868
St. Joseph's Medical Center *Recruiting*
Stockton, California, 95204
United States
Recruiting Theresa Weaver 209-461-5257
UPMC/Shadyside Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Tarra Davis 412-235-1301
University of Rochester/Strong Memorial *Recruiting*
Rochester, New York, 14642
United States
Recruiting Lori Caufield 585-273-4956
Washington Adventist Hospital *Recruiting*
Takoma Park, Maryland, 20912
United States
Recruiting Cathy Garey 301-891-5901
Charleston Area Medical Health Systems *Recruiting*
Charleston, West Virginia, 25304
United States
Recruiting Cyndi Tignor 304-388-9937
Cleveland Clinic *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Robin Hughes 216-444-5937
St. Michael's Hospital *Recruiting*
Newark, New Jersey, 07013
United States
Recruiting Madge Geohagen 973-877-5059
Millard Fillmore Neurosurgery SUNY Buffalo *Recruiting*
Buffalo, New York, 14209
United States
Recruiting Anne Crumlish 716-887-5210
St. Luke's Hospital *Recruiting*
Kansas City, Missouri, 64110
United States
Recruiting Margie Santiago 816-932-6248
University of Medicine and Dentistry of New Jersey *Recruiting*
Newark, New Jersey, 07017
United States
Recruiting
Swedish Heart Institute *Recruiting*
Seattle, Washington, 98122
United States
Recruiting Robyn Martin 206-386-6844
Toronto Hospital *Recruiting*
Toronto, Ontario,
Canada
Recruiting Gail Reintamm 416-603-5800
St. Joseph's Hospital of Atlanta *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Lynn Krug 404-851-7979
Central Baptist Hospital *Recruiting*
Lexington, Kentucky, 40504
United States
Recruiting Linda Breathitt 859-260-6344
Barrow Neurological Institute *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting Sonna Hunsley 602-406-3343
Ochsner Foundation Hospital *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Aura Cole 504-842-5622
Additional Information:
Study ID Numbers: R01NS38384;
Study Start Date: December 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004732
Other Carotid Stenosis Studies:
1. Families In Recovery From Stroke Trial (F.I.R.S.T.)
2. Walking Therapy In Hemiparetic Stroke Patients Using Robotic-Assisted Treadmill Training
3. Effects of Exercise on patients with Hemiparetic Stroke
4. Effects of Flumazenil on Brain Excitability
5. Motor Learning in Stroke Patients and Healthy Volunteers
Related Studies:
Other Carotid Stenosis Clinical Trials
Other Minnesota Clinical Trials
Other Robbinsdale Clinical Trials
Stenting vs. Surgery to Prevent Stroke
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