Registry for a new type of artery graft for dialysis access

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

This study is testing a new type of artery graft to see if it can safely and effectively help adults with kidney failure get the dialysis access they need.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: LifeNet Health (Industry-sponsored)
• Locations: 4 sites (Mobile, Alabama and 3 other locations)
• Trial ID: NCT05880537 on ClinicalTrials.gov

What this trial studies

This observational registry aims to evaluate the safety and effectiveness of the Nexeon AVX Decellularized Femoral Artery allograft in creating vascular access for hemodialysis in patients with end-stage renal disease (ESRD). Participants will be monitored post-graft placement to assess outcomes related to dialysis access. The study includes adults aged 18 and older who require dialysis access and can provide informed consent. The registry will collect data on patient experiences and graft performance over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with end-stage renal disease requiring hemodialysis and viable options for arterial venous access.

Not a fit: Patients who are not candidates for dialysis access or those with known sensitivities to the graft processing reagents may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve vascular access options for patients with ESRD, enhancing their quality of life and treatment outcomes.

How similar studies have performed: While this specific approach is novel, similar studies involving vascular grafts have shown promising results in improving dialysis access.

Eligibility criteria

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

Where this trial is running

Mobile, Alabama and 3 other locations

• Infirmary Heath — Mobile, Alabama, United States (Recruiting)
• Olive View - UCLA Medical Center — Sylmar, California, United States (Recruiting)
• Harbor-UCLA Medical Center — Torrance, California, United States (Recruiting)
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Kimberly Dorsch

Conditions End-Stage Renal Disease