Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry

Part of paid clinical trials in Mobile, Alabama.

Sponsor
LifeNet Health
Study ID
NCT05880537
Status
Recruiting
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Conditions

  • End-Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nexeon Arterial Venous Allograft — OTHER
    Nexeon AVX allograft for hemodialysis access in end stage renal disease

Study Details

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

Key Dates

Start date
Jun 6, 2023
Status verified
Mar 2025
Primary completion
Dec 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Open Label
    Open Label for subjects with End-Stage Renal Disease

Primary Outcome Measure

UltraSound evaluation of allograft functional patency. [ Time Frame: 24 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Infirmary HeathMobileAlabama36607
Wendy Blount, MSN
[email protected]
251 435 5931
Cullen McCarthy, MD (PRINCIPAL_INVESTIGATOR)
Olive View - UCLA Medical CenterSylmarCalifornia91342
Rosario Machicado
[email protected]
747 210 8811
Warren Chow, MD (PRINCIPAL_INVESTIGATOR)
Harbor-UCLA Medical CenterTorranceCalifornia90502
Elizabeth Hernandez
[email protected]
949-422-6701
Rowena Buwalda
[email protected]
949-422-6701
Mark Archie, MD (PRINCIPAL_INVESTIGATOR)
Sentara Norfolk General HospitalNorfolkVirginia23507
Amanda Anderson
[email protected]
757 388 2407
Animesh Rathore, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Mobile, AL

By research site
Infirmary Heath· Mobile, ALOlive View - UCLA Medical Center· Sylmar, CAHarbor-UCLA Medical Center· Torrance, CASentara Norfolk General Hospital· Norfolk, VA

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