Registry for a new type of artery graft for dialysis access

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: kimberly_dorsch@lifenethealth.org
• Phone: 757-609-4378

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.