[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506911":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":29,"overallOfficials":17,"centralContacts":35,"locations":45,"responsibleParty":121,"collaborators":17,"id":123,"slug":17,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":17,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":17,"enrollmentInfo":131,"targetDuration":134,"studyType":135,"phases":17,"briefSummary":136,"conditions":137,"keywords":17,"overallStatus":48,"whyStopped":17,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"LifeNet Health","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"UltraSound evaluation of allograft functional patency.","Ultrasound proof of vessel patency and blood flow","24 months",[14],{"measure":15,"description":16,"timeFrame":12},"Secondary Endpoint:","Evaluating the emergent adverse events as it pertains to the hemodialysis access anatomical site",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"CASE_ONLY","PROSPECTIVE","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.","The registry subject population will consist of male and female research subjects, 18 years of age or older at the time of graft placement, who require vascular access for hemodialysis that the surgeon determines, in their medical judgement, to be a candidate to receive the Nexeon AVX graft. The target study enrollment is 100 subjects. Each subject will be followed for a maximum of two (2) years or 24 months post-graft placement.",[24],{"label":25,"type":17,"description":26,"interventionNames":27},"Open Label","Open Label for subjects with End-Stage Renal Disease",[28],"Other: Nexeon Arterial Venous Allograft",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":17},"OTHER","Nexeon Arterial Venous Allograft","Nexeon AVX allograft for hemodialysis access in end stage renal disease",[25],[36,41],{"name":37,"role":38,"phone":39,"phoneExt":17,"email":40},"Kimberly Dorsch","CONTACT","757-609-4378","kimberly_dorsch@lifenethealth.org",{"name":42,"role":38,"phone":43,"phoneExt":17,"email":44},"Monique Alston-Epps","757-713-4657","monique_alstonepps@lifenethealth.org",[46,68,85,104],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Infirmary Heath","RECRUITING","Mobile","Alabama","36607","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-88.04305,30.69436,{"lat":58,"lon":57},[61,65],{"name":62,"role":38,"phone":63,"phoneExt":17,"email":64},"Wendy Blount, MSN","251 435 5931","wendy.blount@infirmaryhealth.org",{"name":66,"role":67,"phone":17,"phoneExt":17,"email":17},"Cullen McCarthy, MD","PRINCIPAL_INVESTIGATOR",{"facility":69,"status":48,"city":70,"state":71,"zip":72,"country":52,"countryCode":53,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Olive View - UCLA Medical Center","Sylmar","California","91342",{"type":55,"coordinates":74},[75,76],-118.44925,34.30778,{"lat":76,"lon":75},[79,83],{"name":80,"role":38,"phone":81,"phoneExt":17,"email":82},"Rosario Machicado","747 210 8811","rmachicado@dhs.lacounty.gov",{"name":84,"role":67,"phone":17,"phoneExt":17,"email":17},"Warren Chow, MD",{"facility":86,"status":48,"city":87,"state":71,"zip":88,"country":52,"countryCode":53,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Harbor-UCLA Medical Center","Torrance","90502",{"type":55,"coordinates":90},[91,92],-118.34063,33.83585,{"lat":92,"lon":91},[95,99,102],{"name":96,"role":38,"phone":97,"phoneExt":17,"email":98},"Elizabeth Hernandez","949-422-6701","ehernandez@lundquist.org",{"name":100,"role":38,"phone":97,"phoneExt":17,"email":101},"Rowena Buwalda","rbuwalda@dhs.lacounty.gov",{"name":103,"role":67,"phone":17,"phoneExt":17,"email":17},"Mark Archie, MD",{"facility":105,"status":48,"city":106,"state":107,"zip":108,"country":52,"countryCode":53,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Sentara Norfolk General Hospital","Norfolk","Virginia","23507",{"type":55,"coordinates":110},[111,112],-76.28522,36.84681,{"lat":112,"lon":111},[115,119],{"name":116,"role":38,"phone":117,"phoneExt":17,"email":118},"Amanda Anderson","757 388 2407","aganders@sentara.com",{"name":120,"role":67,"phone":17,"phoneExt":17,"email":17},"Animesh Rathore, MD",{"type":122,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100506911",false,"NCT05880537","Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry","Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft for Arteriovenous Access for Hemodialysis: A Multi-center Prospective Registry Study","Inclusion Criteria:\n\n1. Be male or female, ≥18 years of age at the time of graft placement\n2. Have a diagnosis of ESRD or renal dysfunction requiring hemodialysis\n3. Subject requires dialysis access to start or maintain dialysis treatment and placement of an AV access graft is a viable access option.\n4. Have the ability themselves, or through their legal guardian, to understand the requirements of the study, to provide written informed consent\u002Fassent 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\n5. Have provided written authorization for use and disclosure of protected health information\n\nExclusion Criteria:\n\n1. Be participating in a study of another investigational drug or device\n2. 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\u002Fglycerin)\n3. Have a history or evidence of severe cardiac disease, myocardial infarction within 6 months, ventricular arrhythmias, or unstable angina requiring continuing treatment\n4. Have a history or evidence of severe peripheral vascular disease in the upper extremities\n5. Have the inability or be unable or unwilling to follow the study visit schedule\n6. 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","ALL","18 Years",{"count":132,"type":133},100,"ESTIMATED","24 Months","OBSERVATIONAL","Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,",[138],"End-Stage Renal Disease","2025-03-28",{"date":141,"type":142},"2025-04-02","ACTUAL",{"date":144,"type":142},"2023-06-06",{"date":146,"type":133},"2027-12-15",{"name":5,"class":6},4]