A prospective, single arm, non-randomized pivotal study to evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start or maintain hemodialysis therapy
✓. At least 18 years of age at screening
✓. Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess graft
✓. The patient, or legal representative, 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 six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
✕. Uncontrolled or poorly controlled diabetes
✕. Abnormal blood values 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
✕
What they're measuring
1
Primary patency rate
Timeframe: 6 months
2
Freedom from device-related SAE during the first 6 months