Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nexeon Arterial Venous Allograft.
- Who it may be relevant to
- Registry conditions: End-Stage Renal Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft for Arteriovenous Access for Hemodialysis: A Multi-center Prospective Registry Study
Overview
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
Detailed description
The clinical objective of this prospective, observational, post market registry study, CR-21-005, is to assess the safety and efficacy of a 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 ESRD.
Interventions
- Other Nexeon Arterial Venous Allograft
Nexeon AVX allograft for hemodialysis access in end stage renal disease
Primary outcome measures
- UltraSound evaluation of allograft functional patency. [Time frame: 24 months]
Secondary outcome measures (1)
- Secondary Endpoint: [Time frame: 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 4 centers
- Infirmary Heath — Mobile
- Olive View - UCLA Medical Center — Sylmar
- Harbor-UCLA Medical Center — Torrance
- Sentara Norfolk General Hospital — Norfolk
Identifiers
NCT: NCT05880537 · CR-21-005