An interventional study of aXess-E conduit in End Stage Renal Disease, sponsored by Xeltis. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Xeltis · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Intra-operative exclusion criteria:
1. Unsuitable anatomy to implant the aXess-E conduit (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)
Device: aXess-E conduit
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.
Primary Patency rate
Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.
Time frame: 6 months
Freedom from device-related Serious Adverse Event (SAE)
Time frame: 6 months
Implantation success rate
Defined as a technically successful aXess-E conduit implantation in the planned configuration, free from kinking and tension in the anastomoses.
Time frame: 1 day, from moment of implant until end of procedure day
Primary patency rate
Primary patency: Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.
Time frame: 6, 12, 18, and 24 months
Primary assisted patency rate
Assisted primary patency: Defined as the interval between vascular access creation and the first occlusion (thrombosis), including interventions (operative or endovascular) aimed to maintain the functionality the vascular access.
Time frame: 6, 12, 18, and 24 months
Secondary patency rate
Secondary patency: Defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain the functionality the vascular access, including occurrence of a censored event (death, change of modality, loss of follow-up).
Time frame: 6, 12, 18, and 24 months
Functional patency rate
Functional patency: Defined as the interval between first cannulation and abandonment, including occurrence of a censored event (death, change of modality, loss of follow-up).
Time frame: 6, 12, 18, and 24 months
Time (expressed in months) to first intervention and to access abandonment
Time frame: 24 months
Rate of access-related interventions required to achieve/maintain patency
Time frame: 6, 12, 18, and 24 months
Freedom from device-related SAE
Time frame: 12, 18, and 24 months
Rate of access site infections
Time frame: 6, 12, 18, and 24 months
Proportion of hemodialysis sessions completed via central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment
Time frame: 24 months
Time to first cannulation
Assessed only in subjects who are already on dialysis at the time of implant.
Time frame: 24 months
Following first cannulation, number of days with CVC in situ (catheter contact time) irrespective of access abandonment
Time frame: 12 months
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