Randomized Controlled, 3 Arm Clinical Trial Comparing EXXCEL Soft, FUSION and FUSION Bioline



Status:Archived
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:April 2010
End Date:March 2012

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Comparison of Safety and Primary Patency Between FUSIONTM Vascular Graft, FUSIONTM Vascular Graft With BiolinE, and EXXCELTM Soft ePTFE (FINEST)


To demonstrate The purpose of the study is to compare the performance EXXCEL with FUSION and
FUSION Bioline at 6 months. The investigators expect the performance of the grafts to be
similar.


The study is a prospective, randomized, single-blind, three-arm, parallel group,
multi-center study to evaluate the safety and efficacy of the FUSIONâ„¢ Vascular Graft and the
FUSIONâ„¢ Vascular Graft with Bioline (heparin) coating, compared with EXXCEL Soft ePTFE in a
peripheral bypass setting, to support a claim of substantial equivalence.


We found this trial at
8
sites
43 New Scotland Avenue
Albany, New York 12208
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Albany, NY
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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Little Rock, AR
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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Birmingham, Alabama 35294
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Birmingham, AL
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506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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Brooklyn, NY
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New York, NY
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