Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry

NCT05880537 | Recruiting

• 1 other identifier: CR-21-005
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

End-Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• UltraSound evaluation of allograft functional patency.

  Ultrasound proof of vessel patency and blood flow

  24 months

Secondary Outcomes (1)

• Secondary Endpoint:

  24 months

Study Arms (1)

Open Label

Open Label for subjects with End-Stage Renal Disease

Other: Nexeon Arterial Venous Allograft

Interventions

Nexeon Arterial Venous Allograft OTHER

Nexeon AVX allograft for hemodialysis access in end stage renal disease

Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Be male or female, ≥18 years of age at the time of graft placement
• Have a diagnosis of ESRD or renal dysfunction requiring hemodialysis
• Subject requires dialysis access to start or maintain dialysis treatment and placement of an AV access graft is a viable access option.
• 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
• Have provided written authorization for use and disclosure of protected health information

You may not qualify if:

• Be participating in a study of another investigational drug or device
• 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)
• Have a history or evidence of severe cardiac disease, myocardial infarction within 6 months, ventricular arrhythmias, or unstable angina requiring continuing treatment
• Have a history or evidence of severe peripheral vascular disease in the upper extremities
• Have the inability or be unable or unwilling to follow the study visit schedule
• 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

Sponsors & Collaborators

• LifeNet Health: lead

Study Sites (4)

Infirmary Heath

Mobile, Alabama, 36607, United States

RECRUITING

Olive View - UCLA Medical Center

Sylmar, California, 91342, United States

RECRUITING

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kimberly Dorsch

CONTACT

757-609-4378; kimberly_dorsch@lifenethealth.org

Monique Alston-Epps

CONTACT

757-713-4657; monique_alstonepps@lifenethealth.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: May 30, 2023
• Study Start: June 6, 2023
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)