Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Warren Chow, MD (ucla)Mark Archie, MD (ucla)

Description

Summary

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

Official Title

Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft for Arteriovenous Access for Hemodialysis: A Multi-center Prospective Registry Study

Details

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.

Keywords

End-Stage Renal Disease, Chronic Kidney Failure, Nexeon Arterial Venous Allograft, Open Label

Eligibility

Locations

  • Olive View - UCLA Medical Center accepting new patients
    Sylmar California 91342 United States
  • Harbor-UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • Infirmary Heath accepting new patients
    Mobile Alabama 36607 United States
  • Sentara Norfolk General Hospital accepting new patients
    Norfolk Virginia 23507 United States

Lead Scientists at University of California Health

  • Warren Chow, MD (ucla)
    HS Assistant Clinical Professor, Surgery, Medicine
  • Mark Archie, MD (ucla)
    HS Associate Clinical Professor, Surgery, Medicine. Authored (or co-authored) 15 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
LifeNet Health
ID
NCT05880537
Study Type
Observational [Patient Registry]
Participants
Expecting 100 study participants
Last Updated