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Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft (Nexeon AVX)

Primary Purpose

End-Stage Renal Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nexeon Arterial Venous Allograft
Sponsored by
LifeNet Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Olive View - UCLA Medical Center
  • Harbor-UCLA Medical CenterRecruiting
  • Sentara Norfolk General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm Description

Open Label for subjects with End-Stage Renal Disease

Outcomes

Primary Outcome Measures

UltraSound evaluation of allograft functional patency.
Ultrasound proof of vessel patency and blood flow

Secondary Outcome Measures

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

Full Information

First Posted
March 1, 2023
Last Updated
September 27, 2023
Sponsor
LifeNet Health
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1. Study Identification

Unique Protocol Identification Number
NCT05880537
Brief Title
Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft (Nexeon AVX)
Official Title
Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft for Arteriovenous Access for Hemodialysis: A Multi-center Prospective Registry Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
December 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeNet Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
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 End-Stage Renal Disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Label
Arm Type
Experimental
Arm Description
Open Label for subjects with End-Stage Renal Disease
Intervention Type
Other
Intervention Name(s)
Nexeon Arterial Venous Allograft
Intervention Description
Nexeon AVX allograft for hemodialysis access in end stage renal disease
Primary Outcome Measure Information:
Title
UltraSound evaluation of allograft functional patency.
Description
Ultrasound proof of vessel patency and blood flow
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Secondary Endpoint:
Description
Evaluating the emergent adverse events as it pertains to the hemodialysis access anatomical site
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Olive View - UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosario Machicado, SC
Phone
747-210-8811
Email
rmachicado@dhs.lacounty.gov
First Name & Middle Initial & Last Name & Degree
Warren Chow, MD
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hernandez, SC
Phone
949-422-6701
Email
ehernandez@lundquist.org
First Name & Middle Initial & Last Name & Degree
Rowena Buwalda, SC
Phone
949-422-6701
Email
rbuwalda@dhs.lacounty.gov
First Name & Middle Initial & Last Name & Degree
Mark Archie, MD
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Havert, SC
Phone
757-388-2991
Email
ssharvert@sentara.com
First Name & Middle Initial & Last Name & Degree
Animesh Rathore, MD

12. IPD Sharing Statement

Learn more about this trial

Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft (Nexeon AVX)

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