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The Boston Scientific ACCESS trial seeks to study the safety and to evaluate the success of the Fusion™ Vascular Access Graft for patients in need of early vascular access for hemodialysis.
The Boston Scientific ACCESS trial seeks to study the safety and to evaluate the success of the Fusion™ Vascular Access Graft for patients in need of early vascular access for hemodialysis. The primary objective is to demonstrate that secondary patency at 6 months for the Fusion™ Vascular Access Graft is not less than an objective performance criterion (OPC) minus a clinically relevant margin (δ). The OPC represents secondary patency at 6 months for the standard of care access grafts.
The secondary safety endpoint is the occurrence of CEC-adjudicated device or procedure related adverse events through 24 months post implant procedure, or through discharge for patients with unsuccessful device implantation. Secondary efficacy endpoints include:primary patency; primary assisted patency; ability to revise a failed graft; early access capability; time to hemostasis.
Subjects will undergo a thorough medical assessment and physical examination pre-procedure and will be assessed peri-procedure. Enrolled subjects with a device implanted will be evaluated at 1, 6, 12, 18 and 24 months post implant procedure.
Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
vascular access graft implantation
Long Beach VA Medical Center
Active, not recruiting
Published on BioPortfolio: 2014-08-27T03:47:22-0400
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Cardiovascular disease (CVD)
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