Tests the aXess-E conduit for dialysis access in people with kidney failure
Tests the aXess-E conduit as dialysis access in adults with end-stage kidney disease.
Plain-language title generated from the registry record
Registry title: Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study
Key facts
- Where
- Belgrade, SerbiaSee the site
Where in Serbia
- Kliničko bolnički centar Zvezdara Klinika za Interne BolestiBelgrade, SerbiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xeltis
- Trial code
- NCT06329310
- Record updated
- 29 July 2026
- Original description
A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, 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.Read full original descriptionShow less
Prospective, Non-randomized Feasibility Study to Confirm the Safety and Performance of the Xeltis Hemodialysis Access Conduit: aXess-E Study
A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, 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.
Inclusion: Subjects with end-stage renal disease (ESRD) who require placement of an Arteriovenous Graft (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-E conduit; The patient has been informed about the nature of the study, understands and agrees to its provisions, and has personally 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: Anticipated renal transplant within 6 months; Previous dialysis access conduit in the operative limb unless the aXess-E conduit can be placed more proximally than the previous failed conduit; Previous enrolment in this study; Unsuitable anatomy to implant the aXess-E conduit (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification); Uncontrolled or poorly controlled diabetes; Any active local or systemic infection; 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; Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit; Intra-operative exclusion criteria:; 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; 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; Abnormal blood values that could influence patient recovery and or/ conduit hemostasis; Known heparin-induced thrombocytopenia; Known or suspected central vein obstruction on the side of planned conduit implantation; Subject is participating in another study; Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives.