Xeltis Hemodialysis Access Graft (aXess) US Study (NCT06494631) | Clinical Trial Compass
By InvitationNot Applicable
Xeltis Hemodialysis Access Graft (aXess) US Study
United States140 participantsStarted 2024-11-11
Plain-language summary
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.
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 (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.