The Boston Scientific ACCESS Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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ACCESS: Prospective, Multi-center Trial of the Fusion Vascular Access Graft for Patients Who Require Early Vascular Access for Hemodialysis

Conditions
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Renal Disease, Kidney Failure

Intervention / Treatment
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* Device: vascular access graft implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Need for early dialysis access (≤72 hours after implantation): Initiation of maintenance dialysis is recommended per K/DOQI or institutional guidelines; or Patient is currently receiving dialysis via catheter No prior implantation of synthetic graft in the arm to be treated Life expectancy of at least 2 years, based on physician's assessment of medical condition Exclusion Criteria: Patient younger than 18 years of age Any stenosis in the veins proximal to (downstream of) implant site, as determined previously or by current ultrasound Pregnancy Bleeding disorder, e.g., low platelet count (<50,000), hypercoagulable state, e.g., antithrombin III deficiency; antiphospholipid or anticardiolipin antibodies; Factor V Leiden; circulating Lupus anticoagulant; current, active heparin-induced thrombocytopenia; Protein C or S deficiency; or history of recurrent deep vein thrombosis not related to AV access. Active malignancy, e.g., condition either being treated or considered untreatable Active systemic infection, e.g., condition either being treated or considered untreatable Uncontrolled major symptomatic medical problem, e.g., undiagnosed severe pain, metabolic disturbance, fever, etc. Likelihood of poor compliance to required dialysis protocol, e.g., history of poor attendance to required clinic sessions or non-compliance to medication Mental incapacity; inability to understand treatment instructions Currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Device: vascular access graft implantation<br>* vascular access graft implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary patency at 6 months as determined by ability of the graft to be used for vascular access for hemodialysis |  | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular access, hemodialysis