NexeonAVX: Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft

Sponsor

LifeNet Health (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05880537

Collaborator

(none)

100

Enrollment

Locations

Arm

30.8

Anticipated Duration (Months)

33.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease	Biological: Nexeon AVX	Early Phase 1

Detailed Description

The clinical objective of this study, CR-21-005, is to assess the safety and efficacy of a novel 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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This study is a prospective registry trial designed to evaluate the efficacy and safety of a novel decellularized human femoral artery allograft (Nexeon AVX) in the creation of vascular access for Intraoperative information related to surgical outcome, reintervention, and immunogenicity will be collected.This study is a prospective registry trial designed to evaluate the efficacy and safety of a novel decellularized human femoral artery allograft (Nexeon AVX) in the creation of vascular access for Intraoperative information related to surgical outcome, reintervention, and immunogenicity will be collected.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

May 22, 2023

Anticipated Primary Completion Date :

Dec 15, 2024

Anticipated Study Completion Date :

Dec 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Open Label Open Label for subjects with end stage renal disease	Biological: Nexeon AVX Nexeon AVX allograft for hemodialysis access in end stage renal disease

Arm

Intervention/Treatment

Experimental: Open Label

Open Label for subjects with end stage renal disease

Biological: Nexeon AVX

Nexeon AVX allograft for hemodialysis access in end stage renal disease

Outcome Measures

Primary Outcome Measures

Establishing vascular access for patients needing hemodialysis and evaluating the outcome of aneurysm formation, anastomotic bleeding, graft infection, and irritation and inflammation at the implant site. [24 months]
Establishing vascular access for patients needing hemodialysis while measuring the outcomes of aneurysm formation, anastomotic bleeding, graft infection, and irritation and inflammation at the implant site.

Secondary Outcome Measures

Secondary Endpoint: [24 months]
Evaluating the emergent adverse events as it pertains to the hemodialysis access anatomical site

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Olive View - UCLA Medical Center	Sylmar	California	United States	91342
2	Harbor-UCLA Medical Center	Torrance	California	United States	90502
3	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

LifeNet Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LifeNet Health

ClinicalTrials.gov Identifier:

NCT05880537

Other Study ID Numbers:

CR-21-005

First Posted:

May 30, 2023

Last Update Posted:

May 30, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by LifeNet Health

End Stage Renal Disease requiring Dialysis

Additional relevant MeSH terms:

Kidney Diseases

Kidney Failure, Chronic

Study Results

No Results Posted as of May 30, 2023