Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft (Nexeon AVX)

Study Overview
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Brief Summary
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To assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,

Detailed Description
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The clinical objective of this study, CR-21-005, is to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery, LifeNet Health, Virginia Beach, VA) in the creation of vascular access for hemodialysis in patients with End-Stage Renal Disease.

Official Title
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Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft for Arteriovenous Access for Hemodialysis: A Multi-center Prospective Registry Study

Conditions
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End-Stage Renal Disease

Intervention / Treatment
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* Other: Nexeon Arterial Venous Allograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be male or female, ≥18 years of age at the time of graft placement Have a diagnosis of ESRD or renal dysfunction requiring hemodialysis Subject requires dialysis access to start or maintain dialysis treatment and placement of an AV access graft is a viable access option. Have the ability themselves, or through their legal guardian, to understand the requirements of the study, to provide written informed consent/assent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and to agree to abide by the study restrictions and return to the site for the required assessments Have provided written authorization for use and disclosure of protected health information Exclusion Criteria: Be participating in a study of another investigational drug or device Have a known sensitivity to any of the processing reagents utilized in the manufacture of this product such as antibiotics (Lincomycin, Polymyxin B, Ciprofloxacin, Meropenum, Gentamicin, or Vancomycin) and processing reagents (N-lauroyl sarcosine, Denarase and glycerol/glycerin) Have a history or evidence of severe cardiac disease, myocardial infarction within 6 months, ventricular arrhythmias, or unstable angina requiring continuing treatment Have a history or evidence of severe peripheral vascular disease in the upper extremities Have the inability or be unable or unwilling to follow the study visit schedule Have the presence of any condition that, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated

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
Interventional Model Description: This study is a prospective registry trial designed to evaluate the efficacy and safety of a novel decellularized human femoral artery allograft (Nexeon AVX) in the creation of vascular access for Intraoperative information related to surgical outcome, reintervention, and immunogenicity will be collected.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label<br>Open Label for subjects with End-Stage Renal Disease | Other: Nexeon Arterial Venous Allograft<br>* Nexeon AVX allograft for hemodialysis access in end stage renal disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UltraSound evaluation of allograft functional patency. | Ultrasound proof of vessel patency and blood flow | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoint: | Evaluating the emergent adverse events as it pertains to the hemodialysis access anatomical site | 24 months |