Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study
Prospective, Non-randomized Feasibility Study to Confirm the Safety and Performance of the Xeltis Hemodialysis Access Conduit: aXess-E Study
Xeltis
20 participants
Dec 16, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria16
- 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
- Uncontrolled or poorly controlled diabetes
- Abnormal blood values that could influence patient recovery and or/ conduit 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
- Known heparin-induced thrombocytopenia
- 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
- Anticipated renal transplant within 6 months
- Known or suspected central vein obstruction on the side of planned conduit implantation
- 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
- Subject is participating in another study
- Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
- Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit
- \. Unsuitable anatomy to implant the aXess-E conduit (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)
Interventions
The aXess-E conduit is a sterile, regenerative biodegradable polymer-based vascular conduit, consisting of a tubular structure with a 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The aXess-E conduit is able to support both straight and loop configurations and may be implanted in the upper arm and forearm.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06329310