Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry

End-Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880537
• Other study ID #: CR-21-005
• Status: Recruiting
• Start date: June 6, 2023
• Est. completion date: December 15, 2027

Study information

• Verified date: January 2024
• Source: LifeNet Health
• Contact: Kimberly Dorsch
• Phone: 757-609-4378
• Email: kimberly_dorsch[@]lifenethealth.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 15, 2027
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• Nexeon Arterial Venous Allograft
Nexeon AVX allograft for hemodialysis access in end stage renal disease

Locations

Country	Name	City	State
United States	Infirmary Heath	Mobile	Alabama
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Olive View - UCLA Medical Center	Sylmar	California
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
LifeNet Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UltraSound evaluation of allograft functional patency.	Ultrasound proof of vessel patency and blood flow	24 months
Secondary	Secondary Endpoint:	Evaluating the emergent adverse events as it pertains to the hemodialysis access anatomical site	24 months