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 |
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
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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529 West Markham Street
Little Rock, Arkansas 72205
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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Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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