Kidney Diseases Clinical Trial
Official title:
Trial to Assess the Effectiveness of Maintaining Patency and Safety of the Vascular Wrap Paclitaxel-Eluting Mesh After Surgical Implantation With the Lifespan® ePTFE Vascular Graft in the Upper Extremity for Hemodialysis Vascular Access
This is a multi-center clinical study in subjects requiring arteriovenous grafts in the
upper extremity for hemodialysis access. All subjects will provide informed consent before
undergoing any study procedures. The study will consist of multiple subject visits and
telephone contacts during the 52 week study period. During the study period subjects must
also maintain an appropriate hemodialysis schedule.
IDE Number: G060250
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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