Carotid Stenting vs. Surgery of Severe Carotid Artery Disease and Stroke Prevention in Asymptomatic Patients (ACT I)



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:April 2005
End Date:December 2019
Contact:Leah Green
Email:leah.green@av.abbott.com
Phone:408-845-3000

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Trial Summary
Trial Overview
Inclusion Criteria

Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)


The study is being conducted to demonstrate the non-inferiority of carotid artery stenting
(CAS) using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System to
carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid
atherosclerotic disease.


Randomization for ACT 1 employs a 3:1 ratio of CAS versus CEA. A lead-in phase of up to 400
carotid stent subjects will provide investigators experience with the study devices prior to
pivotal enrollment.

Inclusion Criteria:

- Severe carotid artery disease

- Patients who have not had symptoms related to their carotid artery disease in the
last 180 days

- Patients who are able to undergo either an interventional stenting or surgical
procedure

Exclusion Criteria:

- Patients who have had symptoms in the last 180 days

- Patients who are high risk for surgery

- Patients who have certain conditions that might confound the results of the study
We found this trial at
64
sites
Dallas Veteran's Administration Medical Center
Dallas, Texas 75390
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Baptist Cardiac and Vascular Institute
8900 North Kendall Drive
Miami, Florida 33176
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Miami, FL
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Hospital of the University of Pennsylvania
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
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Deaconess Medical Center
800 West 5th Avenue
Spokane, Washington 99210
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Spokane, WA
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Cape Cod Research Institute
, Maine 02601
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Albany Medical College
47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
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Albany, NY
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Piedmont Hospital
1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Atlanta, GA
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Heart Hospital of Austin
Austin, Texas 78756
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Austin, TX
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Westlake Medical Center Seton Heart Institute
Austin, Texas 78705
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Austin, TX
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Johns Hopkins Bayview Medical Center
4940 Eastern Ave
Baltimore, Maryland 21224
(410) 550-0100
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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Heritage Valley Health System
Beaver, Pennsylvania 15009
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Millard Fillmore Hospital
Buffalo, New York 14209
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Our Lady of Lourdes Medical Center
Camden, New Jersey 08103
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Northwestern University Memorial Hospital
Chicago, Illinois 60611
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Chicago, IL
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Rush University Medical Center
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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Cleveland Clinic Foundation
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Providence Hospital-SC
Columbia, South Carolina 29204
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Riverside Methodist Hospital
3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
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Presbyterian Hospital of Dallas
Dallas, Texas 75231
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Harper University Hospital - Detroit Medical Center
Detroit, Michigan 48201
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Duke Univ Med Ctr
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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McLaren Regional Medical Center
Flint, Michigan 48507
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Parkview Hospital
Fort Wayne, Indiana 46805
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Northeast Georgia Medical Center
743 Spring St NE
Gainesville, Georgia 30501
770-219-9000
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The Stern Cardiovascular Center/Methodist Germantown Hospital
Germantown, Tennessee 38138
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Harrisburg Hospital / Pinnacle Health
Harrisburg, Pennsylvania 17110
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Hawaii Permanente Medical Group - Kaiser
Honolulu, Hawaii 96819
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St. Luke's Episcopal Hospital
Houston, Texas 77030
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St. Vincent's Hospital
Indianapolis, Indiana 46260
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Wellmont Holston Valley Medical Center
Kingsport, Tennessee 37660
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Mercy Medical West/Turkey Creek Medical Center
Knoxville, Tennessee 37934
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Cardiovascular Institute of the South
Lafayette, Louisiana 70506
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Lafayette, LA
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Dartmouth Hitchcock Medical Center
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Central Baptist Hospital
1740 Nicholasville Rd
Lexington, Kentucky 40503
(859) 260-6100
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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University of Louisville
500 S Preston St
Louisville, Kentucky
(502) 852-5555
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University of Wisconsin
Madison, Wisconsin 53792
(608) 263-2400
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St. Luke's Medical Center - Milwaukee
Milwaukee, Wisconsin 53215
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Fogarty Clinical Research Inc./El Camino Hospital
Mountain View, California 94040
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Ochsner Medical Center
1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
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Lenox Hill Hospital
New York, New York 10021
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Columbia Presbyterian Hospital
New York, New York 10021
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NYU Medical Center
New York, New York 10016
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Hoag Memorial Hospital
Newport Beach, California 92663
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Chesapeake General Hospital/Sentara Norfolk General Hospital
Norfolk, Virginia 23507
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St. Joseph Hospital
Orange, California 92868
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St. Luke's Hospital-Phoenix
Phoenix, Arizona 85006
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Mayo Clinic
5777 East Mayo Boulevard
Phoenix, Arizona 85054
(480) 515-6296
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University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania 15213
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University of Pittsburgh Physicians Division of Vascular Surgery/Shadyside Medical
Pittsburgh, Pennsylvania 15232
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Allegheny General Hospital
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
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Oregon Health and Science University Stroke Center
Portland, Oregon 97239
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Portland, OR
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WakeMed Health and Hospital
Raleigh, North Carolina 27610
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Raleigh, NC
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St. Mary's Hospital / Virginia Cardiovascular Specilists
Richmond, Virginia 23226
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Richmond, VA
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University of Rochester-Strong Memorial Hospital
Rochester, New York 14618
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St. Francis Hospital
Roslyn, New York 11576
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William Beaumont Hospital-Royal Oak
3601 W 13 Mile Rd
Royal Oak, Michigan 48073
(248) 898-5000
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Kaiser Foundation Hospital-San Diego
San Diego, California 92120
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North Central Heart Institute
Sioux Falls, South Dakota 57108
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St. John's Hospital and Memorial Medical Center/ Prairie Heart Cooperative
Springfield, Illinois 62701
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St. John's Mercy Medical Center
St. Louis, Missouri 63141
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MedStar Washington Hospital Center
110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
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Forsyth Medical Center
Winston-Salem, North Carolina 27103
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St. Joseph's Medical Center/Berks Cardiologists
Wyomissing, Pennsylvania 19610
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