An interventional study of Xeltis Hemodialysis Access (aXess) graft in End-stage Renal Disease, sponsored by Xeltis. Active, not recruiting at 22 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Xeltis · Not applicable, Interventional, and Treatment
A prospective, single arm, non-randomized pivotal study to evaluate the safety and performance of the Xeltis hemodialysis access graft 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 graft (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)
Device: Xeltis Hemodialysis Access (aXess) graft
The aXess graft is a sterile, regenerative biodegradable polymer-based vascular graft, 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 graft 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 SAE during the first 6 months
Time frame: up to 6 months
Implantation success rate
Defined as a technically successful aXess graft implantation in the planned configuration, free from kinking and tension in the anastomoses. This is assessed at the procedure day itself.
Time frame: 1 day, from moment of implant until end of procedure day
Patency (primary, primary assisted, secondary, and functional) rates
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 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 the functionality the vascular access, including occurrence of a censored event (death, change of modality, loss of follow-up). 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, 24 and 60 months
Time (expressed in months) to first intervention and to access abandonment
Time frame: 60 months
Rate of access-related interventions required to achieve/maintain patency
Time frame: 6, 12, 18, 24, and 60 months
Freedom from device-related SAE
Time frame: 12, 18, 24, and 60 months
Rate of access site infections
Time frame: 6, 12, 18, 24, and 60 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: 12 months
Time to first cannulation
Time frame: 12 months
Following first cannulation, number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment
Time frame: 12 months
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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