First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft

Prior treatment

• Stroke within six months before study entry
• Previous dialysis access graft in the operative limb unless the aXess graft can be placed more proximally than the previous failed graft
• Anticipated renal transplant within 6 months
• Subjects receiving a forearm graft which crosses the elbow
• Previous enrollment in this study

Other illness

• History or evidence of severe cardiac disease (NHYA Functional Class IV and/or EF \<30%), myocardial infarction within six months of study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
• Active clinically significant autoimmune / inflammatory disease, immunodeficiency (including AIDS / HIV), use of immunosuppressive therapy or medication that likely interferes with restorative therapies
• Active bleeding disorder and/or any coagulopathy or thrombo embolic disease
• History or evidence of severe peripheral vascular disease in the upper limbs
• Allergies to study device (Nitinol) or agents/medication, such as contrast agents, aspirin, or clopidogrel, that cant be controlled medically
• Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and efficacy of the study conduit

Lab values

• Abnormal blood values (e.g. leurkopenia with white blood cell (WBC) count \< 4,000/mm3 and/or anemia with hemoglobin \<8g/dL and/or thrombocytopenia \< 100,000/mm3) that could influence patient recovery and/or graft hemostasis
• Any active local or systemic infection (WBC \> 15,000/mm3)
• Uncontrolled or poorly controlled diabetes (hemoglovin A1c \> 8% despite standard care) or hospitalization for poor glucose control within the previous 6 months
• Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase; International Normalized Ratio (INR) \> 1.5 or prothrombin time (PT) \> 18 seconds

Other

• Known heparin-induced thrombocytopenia
• Known or suspected central vein obstruction on the side of planned graft implantation
• More than 1 failed dialysis access graft in the operative limb
• Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
• Subject is participating in another study

• Subjects older than 18 years with end-stage renal disease (ESRD) who are not, or who are no longer, candidates for creation of an autogenous AV fistula, and therefore require placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy
• Suitable anatomy for the implantation of an aXess graft
• The patient has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent
• The patient has been informed and agrees to pre- and post- procedure follow up
• Life expectancy of at least 12 months