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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
149
vascular access graft implantation
Long Beach VA Medical Center
Long Beach, California, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
Secondary patency at 6 months as determined by ability of the graft to be used for vascular access for hemodialysis
Time frame: 6 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Boston, Massachusetts, United States
VA New Jersey Healthcare System
East Orange, New Jersey, United States
New York - Presbyterian, Columbia University Medical Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Texas Southwestern / VA Medical Center
Dallas, Texas, United States