Xeltis Hemodialysis Access Graft: aXess Pivotal Study

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Non-randomized Pivotal Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft: aXess Pivotal Study

Conditions
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End-stage Renal Disease

Intervention / Treatment
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* Device: Xeltis Hemodialysis Access (aXess) graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start or maintain hemodialysis therapy At least 18 years of age at screening Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess graft The patient, or legal representative, has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent The patient has been informed and agrees to pre- and post- procedure follow-up Life expectancy of at least 12 months Exclusion Criteria: History or evidence of severe cardiac disease (NYHA Functional Class IV and/or EF <25%), myocardial infarction within six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina Uncontrolled or poorly controlled diabetes Abnormal blood values that could influence patient recovery and or/ graft hemostasis Reduced liver function, defined as: >2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) >1.5 or prothrombin time (PT) >18 seconds Any active local or systemic infection Known heparin-induced thrombocytopenia Known active bleeding disorder and/or any coagulopathy or thromboembolic disease Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically Anticipated renal transplant within 6 months Known or suspected central vein obstruction on the side of planned graft implantation Previous dialysis access graft in the operative limb unless the aXess graft can be placed more proximally than the previous failed graft Previous enrolment in this study Subject is participating in another study Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aXess graft<br> | Device: Xeltis Hemodialysis Access (aXess) graft<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency rate | Defined as the interval between vascular access creation and the first intervention to maintain or restore patency. | 6 months | 
| Freedom from device-related SAE during the first 6 months |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 6, 12, 18, 24 and 60 months | 
| Time (expressed in months) to first intervention and to access abandonment |  | 60 months | 
| Rate of access-related interventions required to achieve/maintain patency |  | 6, 12, 18, 24, and 60 months | 
| Freedom from device-related SAE |  | 12, 18, 24, and 60 months | 
| Rate of access site infections |  | 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 |  | 12 months | 
| Time to first cannulation |  | 12 months | 
| Following first cannulation, number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment |  | 12 months |