Xeltis Hemodialysis Access Graft (aXess) US Study

Inclusion criteria

• Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start (within the first 6 months of follow-up) or maintain hemodialysis therapy and are deemed unsuitable for fistula creation by the investigational surgeon.
• At least 18 years of age at screening.
• Suitable anatomy (e.g. a target vein with a minimum diameter of 4mm) 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.

Exclusion criteria

• History or evidence of severe cardiac disease (NYHA Functional Class IV and/or EF <25%), myocardial infarction within 6 months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina.
• Uncontrolled or poorly controlled diabetes in the opinion of the investigator. Recommended standards of A1c level <8% / 183 mg/dl / 10.2 eAG.
• Abnormal blood values (e.g., leukopenia with white blood cell count (WBC) <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.
• 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.
• Any active local or systemic infection.
• Known heparin-induced thrombocytopenia.
• Known active bleeding disorder and/or any coagulopathy or thromboembolic disease.
• Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically.
• Anticipated renal transplant within 6 months.
• Known or suspected central vein obstruction on the side of planned graft implantation.
• Previous dialysis access graft in the operative limb, unless the aXess graft can be placed more proximally than the previously failed graft.
• Previous enrollment in this study.
• Subject is participating in another study.
• A female who is breastfeeding or of childbearing potential with a positive pregnancy test or not using adequate contraception.
• Any other condition which, in the judgment of the investigator, would preclude adequate evaluation for the safety and performance of the study conduit.

Intra-operative exclusion criteria:

• Unsuitable anatomy to implant the aXess graft (e.g., target vein and/or artery diameter not suitable; severe calcification).