RecruitingNCT05880537

Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry

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


Sponsor

LifeNet Health

Enrollment

100 participants

Start Date

Jun 6, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry study follows patients with end-stage kidney disease who receive a decellularized (processed) femoral artery graft called Nexeon AVX as a way to create a working access site for hemodialysis (a permanent vascular access to connect to a dialysis machine). The study tracks how well the graft works over time. **You may be eligible if...** - You are 18 or older - You have end-stage renal disease (kidney failure) and need hemodialysis - You need a vascular access graft and your doctor recommends this type of graft as a viable option - You are willing to comply with follow-up visits **You may NOT be eligible if...** - You are participating in another investigational study - You have a known allergy to any of the processing agents used to make the graft (certain antibiotics or chemicals) - You have had a heart attack in the past 6 months, severe heart disease, or unstable angina - You have severe peripheral vascular disease in your arms - You are unable or unwilling to attend follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNexeon Arterial Venous Allograft

Nexeon AVX allograft for hemodialysis access in end stage renal disease


Locations(4)

Infirmary Heath

Mobile, Alabama, United States

Olive View - UCLA Medical Center

Sylmar, California, United States

Harbor-UCLA Medical Center

Torrance, California, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05880537


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