Xeltis Hemodialysis Access Graft (aXess) US Study
NCT Number: NCT06494631
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: End Stage Renal Disease
Interventions: DEVICE: Xeltis Hemodialysis Access (aXess) graft
Sponsor: Xeltis
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2032-01

Summary:
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.

Primary Outcome Measures: 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, 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, 12 months
Secondary Outcome Measures: Freedom from device-related SAE, 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., 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., 6, 12, 18, 24, and 60 months|Time to first intervention and to access abandonment, 60 months|Rate of access-related interventions required to achieve/maintain patency, 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., 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, 12 months|Time to the first cannulation, Assessed only in subjects already on dialysis at the time of implant, 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, 12 months|Rate of peri-reintervention vascular injuries, 6 months