Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry

LifeNet Health

Status: Enrolling

Conditions: End-Stage Renal Disease

Treatments: Other: Nexeon Arterial Venous Allograft

Study type: Observational

Funder types: Industry

Identifiers

NCT05880537

CR-21-005

Details and patient eligibility

About

Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be male or female, ≥18 years of age at the time of graft placement
2. Have a diagnosis of ESRD or renal dysfunction requiring hemodialysis
3. Subject requires dialysis access to start or maintain dialysis treatment and placement of an AV access graft is a viable access option.
4. 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
5. Have provided written authorization for use and disclosure of protected health information

Exclusion criteria

1. Be participating in a study of another investigational drug or device
2. 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)
3. Have a history or evidence of severe cardiac disease, myocardial infarction within 6 months, ventricular arrhythmias, or unstable angina requiring continuing treatment
4. Have a history or evidence of severe peripheral vascular disease in the upper extremities
5. Have the inability or be unable or unwilling to follow the study visit schedule
6. 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

Trial design

100 participants in 1 patient group

Open Label

Description:

Open Label for subjects with End-Stage Renal Disease

Treatment:

Other: Nexeon Arterial Venous Allograft