Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery



Status:Archived
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:June 2009
End Date:December 2012

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Comparison of the SUpera® PERipheral System to a Performance Goal Derived From Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery


The main objective of this study is to demonstrate the safety and effectiveness of the IDev
SUPERA® Nitinol Stent System in treating subjects with obstructive superficial femoral
artery (SFA) disease. The primary endpoint will be the primary patency of the SFA evaluated
at 12 months. The outcome will be compared to a performance goal based on clinical trials of
percutaneous transvenous angioplasty (PTA) alone.



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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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22 Bramhall Street
Portland, Maine 04102
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Alice, Texas 78332
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Austin, Texas 78756
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Beaver, Pennsylvania 15009
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Bellingham, Washington 98225
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Beverly Hills, California 90210
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Bossier City, Louisiana 71111
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Bradenton, Florida 34205
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Brighton, Massachusetts 02135
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Browns Mills, New Jersey 08015
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Bryn Mawr, Pennsylvania 19010
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Charlotte, North Carolina 28210
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850 Boylston Street
Chestnut Hill, Massachusetts 02467
1-800-BWH-9999
Brigham & Women's Hospital Women's Health Center At Brigham and Women
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Cincinnati, Ohio 45219
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Cincinnatti, Ohio 45267
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Fishers, Indiana 46038
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Fort Worth, Texas 76104
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Greenville, South Carolina 29605
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Hattiesburg, Mississippi 39401
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Houma, Louisiana 70360
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Hutchinson, Kansas 67502
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Jacksonville, Florida 32216
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Kingsport, Tennessee 37660
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Lafayette, Louisiana 70506
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Lenexa, Kansas 66124
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Little Rock, Alaska 72211
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Liverpool, New York 13088
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Milwaukee, Wisconsin 53211
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Nashville, Tennessee 37212
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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Olney, Maryland 20832
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Opelousas, Louisiana 70570
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Phoenix, Arizona 85006
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Slidell, Louisiana 70458
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Tucson, Arizona 85712
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Tupelo, Mississippi 38801
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Washington, Washington DC 20010
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Winston-Salem, North Carolina 27103
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Wormleysburg, Pennsylvania 17043
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5900 Byron Center Ave SW
Wyoming, Michigan 49519
(616) 252-7200
Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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