First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft

Study Overview
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Brief Summary
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A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.

Detailed Description
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A prospective, single arm, non-randomized FIH feasibility study to evaluate the preliminary 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, and are deemed not suitable for fistula creation by the operating surgeon.

Official Title
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First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess)

Conditions
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End Stage Renal Disease, End Stage Renal Failure on Dialysis

Intervention / Treatment
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* Device: aXess


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects older than 18 years with end-stage renal disease (ESRD) who are not, or who are no longer, candidates for creation of an autogenous AV fistula, and therefore require placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy Suitable anatomy for the implantation of an aXess graft The patient 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 (NHYA Functional Class IV and/or EF <30%), myocardial infarction within six months of study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina Stroke within six months before study entry Active clinically significant autoimmune / inflammatory disease, immunodeficiency (including AIDS / HIV), use of immunosuppressive therapy or medication that likely interferes with restorative therapies Abnormal blood values (e.g. leurkopenia with white blood cell (WBC) count < 4,000/mm3 and/or anemia with hemoglobin <8g/dL and/or thrombocytopenia < 100,000/mm3) that could influence patient recovery and/or graft hemostasis Any active local or systemic infection (WBC > 15,000/mm3) Uncontrolled or poorly controlled diabetes (hemoglovin A1c > 8% despite standard care) or hospitalization for poor glucose control within the previous 6 months Reduced liver function, defined as: >2x the upper limit of normal for serum bilirubin, aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase; International Normalized Ratio (INR) > 1.5 or prothrombin time (PT) > 18 seconds Known heparin-induced thrombocytopenia Active bleeding disorder and/or any coagulopathy or thrombo embolic disease History or evidence of severe peripheral vascular disease in the upper limbs 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 More than 1 failed dialysis access graft in the operative limb Anticipated renal transplant within 6 months Subjects receiving a forearm graft which crosses the elbow Allergies to study device (Nitinol) or agents/medication, such as contrast agents, aspirin, or clopidogrel, that cant be controlled medically Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives Subject is participating in another study Previous enrollment in this study Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and efficacy of the study conduit

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<br>Patients will be implanted with the Xeltis hemodialysis access graft (aXess) | Device: aXess<br>* Patients will be implanted with one Xeltis hemodialysis access device (aXess) in the arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from device related serious adverse events | The number of patients who have a device related serious adverse event | 6 months | 
| Functional patency of graft | The number of patients with a functionally patent graft | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from device related serious adverse events | The number of patients who have a device related serious adverse event | 12, 18, 24, and 60 months | 
| Functional patency of graft | The number of patients with a functionally patent graft | 12, 18, 24, and 60 months | 
| Patency (primary, primary assisted, and secondary) of graft | The number of patients with a patient graft | 6, 12, 18, 24, and 60 months | 
| Time to potential central venous catheter removal | Time that patients with a central venous catheter could have had the catheter removed after the Xeltis hemodialysis access graft was placed | Assessed retrospectively at 30 days | 
| Time to loss of patency (primary, primary assisted, and secondary) | Number of days from implant to graft occlusion in patients who no longer have a patent graft | 6, 12, 18, 24, and 60 months | 
| Rate of access related interventions required to achieve/maintain patency | Number of interventions that were performed on grafts to achieve/maintain patency | 6, 12, and 24 months | 
| Rate of access site infections | Number of access graft sites that become infected | 6, 12, and 24 months | 
| Proportion of hemodialysis (HD) sessions completed via central venous catheter | Number of hemodialysis sessions performed with a central venous catheter vs. the number of sessions performed with the Xeltis hemodialysis access graft | 12 months | 
| Number of days with central venous catheter in place (catheter contact time) | Number of days the patients have a central venous catheter in place irrespective of access abandonment | 12 months | 
| Pseudoaneurysm formation | Number of grafts that have a pseudoaneurysm form | 6, 12, and 24 months |