Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
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.
Study Type
OBSERVATIONAL
Enrollment
100
Nexeon AVX allograft for hemodialysis access in end stage renal disease
Infirmary Heath
Mobile, Alabama, United States
RECRUITINGOlive View - UCLA Medical Center
Sylmar, California, United States
RECRUITINGHarbor-UCLA Medical Center
Torrance, California, United States
RECRUITINGUltraSound evaluation of allograft functional patency.
Ultrasound proof of vessel patency and blood flow
Time frame: 24 months
Secondary Endpoint:
Evaluating the emergent adverse events as it pertains to the hemodialysis access anatomical site
Time frame: 24 months
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Sentara Norfolk General Hospital
Norfolk, Virginia, United States
RECRUITING