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

This trial does not accept healthy volunteers

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 population

The registry subject population will consist of male and female research subjects, 18 years of age or older at the time of graft placement, who require vascular access for hemodialysis that the surgeon determines, in their medical judgement, to be a candidate to receive the Nexeon AVX graft. The target study enrollment is 100 subjects. Each subject will be followed for a maximum of two (2) years or 24 months post-graft placement.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Nexeon Arterial Venous Allograft
Other intervention
Nexeon AVX allograft for hemodialysis access in end stage renal disease

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Open Label1 intervention

Trial outcomes

Primary outcomes

UltraSound evaluation of allograft functional patency.

Ultrasound proof of vessel patency and blood flow

Time frame

24 months

Secondary outcomes

Secondary Endpoint:

Evaluating the emergent adverse events as it pertains to the hemodialysis access anatomical site

Time frame

24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LifeNet Health

Lead sponsor

Source ClinicalTrials.gov

Apply now