Xeltis Hemodialysis Access Graft (aXess) US Study

Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft

A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon.

Inclusion Criteria:

1. 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.
2. At least 18 years of age at screening.
3. Suitable anatomy (e.g. a target vein with a minimum diameter of 4mm) for the implantation of an aXess graft
4. The patient has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent.
5. The patient has been informed and agrees to pre- and post-procedure follow-up.
6. Life expectancy of at least 12 months.

Exclusion Criteria:

1. 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.
2. Uncontrolled or poorly controlled diabetes in the opinion of the investigator. Recommended standards of A1c level <8% / 183 mg/dl / 10.2 eAG.
3. 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.
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 graft implantation.
11. Previous dialysis access graft in the operative limb, unless the aXess graft can be placed more proximally than the previously failed graft.
12. Previous enrollment in this study.
13. Subject is participating in another study.
14. A female who is breastfeeding or of childbearing potential with a positive pregnancy test or not using adequate contraception.
15. 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:

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