Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft for Arteriovenous Access for Hemodialysis: A Multi-center Prospective Registry Study
LifeNet Health
Summary
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 r…
Interventions
- OtherNexeon Arterial Venous Allograft
Nexeon AVX allograft for hemodialysis access in end stage renal disease
Locations (4)
- Infirmary HeathMobile, Alabama
- Olive View - UCLA Medical CenterSylmar, California
- Harbor-UCLA Medical CenterTorrance, California
- Sentara Norfolk General HospitalNorfolk, Virginia