An interventional study of Xeltis aXess Hemodialysis Conduit in End Stage Renal Failure, Hemodialysis, sponsored by Xeltis. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Xeltis · Not applicable, Interventional, and Treatment
A prospective, single arm, non-randomized Post Market Clinical Follow-up (PMCF) registry study to evaluate the safety and performance of the aXess Hemodialysis Conduit, called aXess4All. Intended for Patients older than 18 years of age with end-stage renal disease who require a vascular access for hemodialysis, compliant with the Instructions for Use who consented in study participation.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's planned enrollment of 350 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Xeltis is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients older than 18 years of age with end-stage renal disease who require a vascular access for hemodialysis, compliant with the Instructions for Use who consented in study participation.
Device: Xeltis aXess Hemodialysis Conduit
The aXess Hemodialysis 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 Hemodialysis Conduit is able to support both straight and loop configurations and may be implanted in the upper arm or forearm.
Freedom from major aXess infection
Major aXess infection defined as conduit-related infections resulting in (partial) aXess Hemodialysis Conduit explantation.
Time frame: 12 months post-implant
Primary, primary-assisted and secondary patency
Primary patency: Defined as the interval between vascular access creation and the first intervention to maintain or restore patency. 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 of the vascular access. Secondary patency: Defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain or restore the functionality the vascular access, including occurrence of a censored event (death, change of modality, loss of follow-up).
Time frame: 6, 12, 24, 36, 48 months post-implant
Freedom from major aXess infection
Major aXess infection defined as conduit-related infections resulting in (partial) aXess Hemodialysis Conduit explantation.
Time frame: 6, 24, 36, 48 months post-implant
Rate of interventions to maintain or restore patency
Time frame: 6, 12, 24, 36, 48 months post-implant
Rate of interventions to treat pseudoaneurysms
Time frame: 6, 12, 24, 36, 48 months post-implant
Rate of treatment failures
Treatment failure defined as patients that had an implant attempted but are discharged without a functional aXess Hemodialysis Conduit
Time frame: Day 0 post-implant
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2030, 49 months later.
Of 40 industry-sponsored interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 49 months is above that.
Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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