End-Stage Renal Disease
Conditions
Brief summary
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
Detailed description
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.
Interventions
OTHERNexeon Arterial Venous Allograft
Nexeon AVX allograft for hemodialysis access in end stage renal disease
Sponsors
LifeNet Health
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UltraSound evaluation of allograft functional patency. | 24 months | Ultrasound proof of vessel patency and blood flow |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint: | 24 months | Evaluating the emergent adverse events as it pertains to the hemodialysis access anatomical site |
Countries
United States
Contacts
CONTACTKimberly Dorsch
CONTACTMonique Alston-Epps
Outcome results
None listed