The Boston Scientific ACCESS Trial

Inclusion Criteria:

1. 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
2. No prior implantation of synthetic graft in the arm to be treated
3. Life expectancy of at least 2 years, based on physician's assessment of medical condition

Exclusion Criteria:

1. Patient younger than 18 years of age
2. Any stenosis in the veins proximal to (downstream of) implant site, as determined previously or by current ultrasound
3. Pregnancy
4. 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.
5. Active malignancy, e.g., condition either being treated or considered untreatable
6. Active systemic infection, e.g., condition either being treated or considered untreatable
7. Uncontrolled major symptomatic medical problem, e.g., undiagnosed severe pain, metabolic disturbance, fever, etc.
8. Likelihood of poor compliance to required dialysis protocol, e.g., history of poor attendance to required clinic sessions or non-compliance to medication
9. Mental incapacity; inability to understand treatment instructions
10. Currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study