Decellularized Femoral Artery Transplant for Chronic Kidney Failure
(NexeonAVX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. However, if you have a known sensitivity to certain antibiotics or processing reagents used in the trial, you may be excluded from participating.
Is the Nexeon AVX Decellularized Femoral Artery generally safe for use in humans?
Research on decellularized engineered allografts in sheep shows that these grafts remained open and functional without complications like dilatation or mineralization over 24 weeks, suggesting they are generally safe. However, this data is from animal studies, and human-specific safety data is not provided.12345
How is the Nexeon AVX Decellularized Femoral Artery Allograft treatment different from other treatments for chronic kidney failure?
The Nexeon AVX Decellularized Femoral Artery Allograft is unique because it uses a decellularized artery, which means all cellular components are removed to reduce immune reactions, making it potentially more biocompatible and less likely to be rejected by the body compared to synthetic or traditional grafts.12678
What data supports the effectiveness of the treatment Nexeon AVX Decellularized Femoral Artery Allograft for chronic kidney failure?
Research on similar treatments, like human acellular vessels and tissue-engineered vascular grafts, shows promise in improving safety and effectiveness for hemodialysis access in patients with kidney failure. These treatments have been used successfully in complex cases where traditional options are not viable, suggesting potential benefits for the Nexeon AVX Decellularized Femoral Artery Allograft.19101112
Are You a Good Fit for This Trial?
This trial is for men and women over 18 with end-stage renal disease (ESRD) or kidney dysfunction requiring hemodialysis. Participants need dialysis access, must understand the study's demands, provide written consent, and not be in another drug/device study. Those with severe heart issues, recent myocardial infarction, arrhythmias, unstable angina needing treatment, severe vascular disease in arms or unable to follow the visit schedule are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the decellularized femoral artery allograft for vascular access creation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including ultrasound evaluations of allograft patency
What Are the Treatments Tested in This Trial?
Interventions
- Nexeon AVX Decellularized Femoral Artery
Nexeon AVX Decellularized Femoral Artery is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
LifeNet Health
Lead Sponsor