To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a claim of substantial equivalence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Primary patency at 12 months
Major device complication rates at 12 months
Technical failures
Secondary patency
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