Nexeon Arterial Venous Allograft: Nexeon AVX allograft for hemodialysis access in end stage renal disease
Study summary
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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 restrictions and return to the site for the required assessments
5. Have provided written authorization for use and disclosure of protected health information
Exclusion Criteria:
1. Be participating in a study of another investigational drug or device
2. 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)
3. Have a history or evidence of severe cardiac disease, myocardial infarction within 6 months, ventricular arrhythmias, or unstable angina requiring continuing treatment
4. Have a history or evidence of severe peripheral vascular disease in the upper extremities
5. Have the inability or be unable or unwilling to follow the study visit schedule
6. 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
Primary outcome measure(s)
UltraSound evaluation of allograft functional patency. — 24 months Ultrasound proof of vessel patency and blood flow
Trial sites (4)
Facility
City
Region
Status
Infirmary Heath
Mobile
Alabama
Recruiting
Olive View - UCLA Medical Center
Sylmar
California
Recruiting
Harbor-UCLA Medical Center
Torrance
California
Recruiting
Sentara Norfolk General Hospital
Norfolk
Virginia
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.