NCT05880537 · LifeNet Health
Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry
What this study is about
Post market registry to assess the safety and effectiveness of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
View original scientific description
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
Interventions
OTHER
Nexeon Arterial Venous Allograft
Nexeon AVX allograft for hemodialysis access in end stage renal disease
Primary outcome measures
UltraSound evaluation of allograft functional patency.
Time frame: 24 months
Ultrasound proof of vessel patency and blood flow
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Be male or female, ≥18 years of age at the time of graft placement
- Have a diagnosis of ESRD or renal dysfunction requiring hemodialysis
- Subject requires dialysis access to start or maintain dialysis treatment and placement of an AV access graft is a viable access option.
- 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
- Have provided written authorization for use and disclosure of protected health information
Exclusion criteria
- Be participating in a study of another investigational drug or device
- 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)
- Have a history or evidence of severe cardiac disease, myocardial infarction within 6 months, ventricular arrhythmias, or unstable angina requiring continuing treatment
- Have a history or evidence of severe peripheral vascular disease in the upper extremities
- Have the inability or be unable or unwilling to follow the study visit schedule
- 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
Where
- Mobile, Alabama
- Sylmar, California
- Torrance, California
- Norfolk, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 2, 2025 · Source of record for eligibility and locations