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โ† Trials
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Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry

Recruitingn/aAges 18 Years - anyAllLifeNet Health
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Be male or female, โ‰ฅ18 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
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What it tests

  • Nexeon Arterial Venous Allograft
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Where

4 sites
Infirmary Heath
Mobile, United States
Olive View - UCLA Medical Center
Sylmar, United States
Harbor-UCLA Medical Center
Torrance, United States
Sentara Norfolk General Hospital
Norfolk, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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