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

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: End-Stage Renal Disease
• Intervention / Treatment: Other: Nexeon Arterial Venous Allograft

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

• Study Contact: Name: Kimberly Dorsch; Phone Number: 757-609-4378; Email: kimberly_dorsch@lifenethealth.org
• Study Contact Backup: Name: Monique Alston-Epps; Phone Number: 757-713-4657; Email: monique_alstonepps@lifenethealth.org

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36607
      • Recruiting
      • Infirmary Heath
      • Contact: Wendy Blount, MSN; Phone Number: 251 435 5931; Email: wendy.blount@infirmaryhealth.org
      • Contact: Cullen McCarthy, MD
  • California
    • Sylmar, California, United States, 91342
      • Recruiting
      • Olive View - UCLA Medical Center
      • Contact: Rosario Machicado; Phone Number: 747 210 8811; Email: rmachicado@dhs.lacounty.gov
      • Contact: Warren Chow, MD
    • Torrance, California, United States, 90502
      • Recruiting
      • Harbor-UCLA Medical Center
      • Contact: Elizabeth Hernandez; Phone Number: 949-422-6701; Email: ehernandez@lundquist.org
      • Contact: Rowena Buwalda; Phone Number: 949-422-6701; Email: rbuwalda@dhs.lacounty.gov
      • Contact: Mark Archie, MD
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Sentara Norfolk General Hospital
      • Contact: Amanda Anderson; Phone Number: 757 388 2407; Email: aganders@sentara.com
      • Contact: Animesh Rathore, MD

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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.	Ultrasound proof of vessel patency and blood flow	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: LifeNet Health

Study record dates

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: End Stage Renal Disease requiring Dialysis
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• 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