Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study

Exclusion Criteria

• •1. History or evidence of severe cardiac disease (New York Heart Association (NYHA) Functional Class IV and/or Ejection Fraction (EF) \<25%), myocardial infarction within six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
• •2. Uncontrolled or poorly controlled diabetes
• •3. Abnormal blood values that could influence patient recovery and or/ conduit hemostasis
• •4. Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) \>1.5 or prothrombin time (PT) \>18 seconds
• •5. Any active local or systemic infection
• •6. Known heparin-induced thrombocytopenia
• •7. Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
• •8. Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
• •9. Anticipated renal transplant within 6 months
• •10. Known or suspected central vein obstruction on the side of planned conduit implantation
• •11. Previous dialysis access conduit in the operative limb unless the aXess-E conduit can be placed more proximally than the previous failed conduit
• •12. Previous enrolment in this study
• •13. Subject is participating in another study
• •14. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
• •15. Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit
• •1\. Unsuitable anatomy to implant the aXess-E conduit (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)