Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry
ConditionEnd-Stage Renal Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLifeNet Health
About this trial
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nexeon Arterial Venous Allograft
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov