Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry (NexeonAVX)

March 28, 2025 updated by: LifeNet Health

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

Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
    • California
      • Sylmar, California, United States, 91342
        • Recruiting
        • Olive View - UCLA Medical Center
        • Contact:
        • Contact:
          • Warren Chow, MD
      • Torrance, California, United States, 90502
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General Hospital
        • Contact:
        • Contact:
          • Animesh Rathore, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The registry subject population will consist of male and female research subjects, 18 years of age or older at the time of graft placement, who require vascular access for hemodialysis that the surgeon determines, in their medical judgement, to be a candidate to receive the Nexeon AVX graft. The target study enrollment is 100 subjects. Each subject will be followed for a maximum of two (2) years or 24 months post-graft placement.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open Label
Open Label for subjects with End-Stage Renal Disease
Other: Nexeon Arterial Venous Allograft
Nexeon AVX allograft for hemodialysis access in end stage renal disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UltraSound evaluation of allograft functional patency.
Time Frame: 24 months
Ultrasound proof of vessel patency and blood flow
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Endpoint:
Time Frame: 24 months
Evaluating the emergent adverse events as it pertains to the hemodialysis access anatomical site
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeNet Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2023

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-21-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe