An interventional study of Xeltis Hemodialysis Access (aXess) graft in End Stage Renal Disease, sponsored by Xeltis. Enrolling by invitation at 7 sites in United States. 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 multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon.
Exclusion Criteria:
Intra-operative exclusion criteria:
1. Unsuitable anatomy to implant the aXess graft (e.g., target vein and/or artery diameter not suitable; severe calcification).
Device: Xeltis Hemodialysis Access (aXess) graft
The aXess graft is a sterile, restorative 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.
Secondary patency rate in survivors
Secondary patency is defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain or restore the vascular access's functionality. Patients who died or changed dialysis modality before 12 months will be excluded from the primary effectiveness analysis if loss of secondary patency was not observed before these events
Time frame: 12 months
Rate of device related infections and bleeding
Infections are defined as: All device or procedure related infections potentially resulting from surgical manipulations or device cannulation, including both minor and major infections., Bleeding (procedure or device related bleeding, at least BARC 2) and device related hematoma defined as blood accumulation around the graft arising from the implantation or cannulation that triggered a medical or surgical action
Time frame: 12 months
Freedom from device-related SAE
Time frame: Discharge, 1, 3, 6, 12, 18, 24, and 60 months
Implantation success rate
Defined as a technically successful aXess graft implantation in the planned configuration, free from kinking and tension in the anastomoses.
Time frame: 1 day, from moment of implant until discharge
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 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 vascular access's functionality Functional patency: defined as an AV access that can be cannulated with two dialysis needles for at least 75% of dialysis sessions within a 4-week period to achieve the prescribed dialysis.
Time frame: 6, 12, 18, 24, and 60 months
Time 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, 60 months
Incidence rate of access site infections
Infections are defined as all device or procedure related infections potentially resulting from surgical manipulations or device cannulation, including both minor and major infections.
Time frame: 6, 12, 18, 24, and 60 months
Proportion of hemodialysis sessions completed via a 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 the first cannulation
Assessed only in subjects already on dialysis at the time of implant
Time frame: 12 months
Following the first cannulation, the number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment
Time frame: 12 months
Rate of peri-reintervention vascular injuries
Time frame: 6 months
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