Kidney Failure Clinical Trial
Official title:
ACCESS: Prospective, Multi-center Trial of the Fusion Vascular Access Graft for Patients Who Require 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 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, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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