Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study

Ki vehet részt

• 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

Ki nem vehet részt

• 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