[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504305":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":127,"collaborators":10,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":131,"sex":137,"minAge":138,"maxAge":10,"enrollmentInfo":139,"targetDuration":142,"studyType":143,"phases":10,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"W.L.Gore & Associates","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ESRD patients that require hemodialysis access through the GORE® ACUSEAL Vascular Graft.",null,"Patient population - patients with CKD in ESRD that require hemodialysis access through the GORE® ACUSEAL Vascular Graft.\n\nRegistry subject population - those patients with CKD in ESRD that require hemodialysis access through the GORE® ACUSEAL Vascular Graft meeting the inclusion and exclusion criteria will be eligible for screening for participation in this registry.\n\nThe registry has been designed with broad eligibility criteria to capture real-world GORE® ACUSEAL Vascular Graft use, for which the device is intended to be implanted. Only patients who meet all of the inclusion criteria and none of the exclusion criteria will be implanted.\n\nNo vulnerable populations are included in this registry.",[13],"Device: GORE® ACUSEAL Vascular Graft",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","GORE® ACUSEAL Vascular Graft","The device placement will be performed according to each participating site's standard practice. No specific procedures are required by the protocol.\n\nAt the time of the GORE® ACUSEAL Vascular Grafts implantation, procedural and adverse event information will be collected.",[9],[21],{"name":22,"affiliation":23,"role":24},"Matteo Tozzi","University of Insubria (Italy)","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Elisabetta Ferro","CONTACT","+39 3486244749","eferro@wlgore.com",[32,54,73,96,113],{"facility":33,"status":34,"city":35,"state":10,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Evangelisches Klinikum Bethel (EvKB)","RECRUITING","Bielefeld","33611","Germany","DE",{"type":40,"coordinates":41},"Point",[42,43],8.53333,52.03333,{"lat":43,"lon":42},[46,50,51],{"name":47,"role":28,"phone":48,"phoneExt":10,"email":49},"Burkhard Feidicker, Dr.Med.","+49 52177275122","Burkhard.feidicker@evkb.de",{"name":47,"role":24,"phone":10,"phoneExt":10,"email":10},{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},"Sebastian Voswinkel","SUB_INVESTIGATOR",{"facility":55,"status":34,"city":56,"state":10,"zip":57,"country":37,"countryCode":38,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Ev. DiakonissenKrankenhaus Leipzigemeinnützige","Leipzig","04177",{"type":40,"coordinates":59},[60,61],12.37129,51.33962,{"lat":61,"lon":60},[64,67,69,71],{"name":65,"role":28,"phone":10,"phoneExt":10,"email":66},"Silvio Rohm","silvio.rohm@ediacon.de",{"name":68,"role":24,"phone":10,"phoneExt":10,"email":10},"Silvio Rhom",{"name":70,"role":53,"phone":10,"phoneExt":10,"email":10},"Olaf Richter",{"name":72,"role":53,"phone":10,"phoneExt":10,"email":10},"Irma Shkoza",{"facility":74,"status":34,"city":75,"state":10,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"ASST-Settelaghi Ospedale di Circolo e Fondazione Macchi","Varese","21100","Italy","IT",{"type":40,"coordinates":80},[81,82],8.82511,45.82058,{"lat":82,"lon":81},[85,87,88,90,92,94],{"name":22,"role":28,"phone":10,"phoneExt":10,"email":86},"matteo.tozzi@uninsubria.it",{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"name":89,"role":53,"phone":10,"phoneExt":10,"email":10},"Francesca Mauri",{"name":91,"role":53,"phone":10,"phoneExt":10,"email":10},"Alessandro Zammito",{"name":93,"role":53,"phone":10,"phoneExt":10,"email":10},"Laura Ros",{"name":95,"role":53,"phone":10,"phoneExt":10,"email":10},"Alessandra Bandiera",{"facility":97,"status":34,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"North Bristol NHS Trust Southmead Hospital","Bristol","England","BS10 5NB","United Kingdom","UK",{"type":40,"coordinates":104},[105,106],-2.59665,51.45523,{"lat":106,"lon":105},[109,112],{"name":110,"role":28,"phone":10,"phoneExt":10,"email":111},"Shakeeb A Khan","Shakeeb.Khan@nbt.nhs.uk",{"name":110,"role":24,"phone":10,"phoneExt":10,"email":10},{"facility":114,"status":115,"city":116,"state":99,"zip":117,"country":101,"countryCode":102,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"King's College Hospital NHS Foundation Trust","NOT_YET_RECRUITING","London","SE5 9RS",{"type":40,"coordinates":119},[120,121],-0.12574,51.50853,{"lat":121,"lon":120},[124],{"name":125,"role":28,"phone":10,"phoneExt":10,"email":126},"Domenico Valenti","domenico.valenti@nhs.net",{"type":128,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100504305","registry-of-gore-acuseal-vascular-graft-in-dialysis-access-100504305",false,"NCT05846581","Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access","Observational Prospective Post-Market Clinical Follow-Up (PMCF) Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access","AVG22-09","Inclusion Criteria:\n\n1. The patient requires the creation of vascular access for hemodialysis secondary to a diagnosis of End-Stage Renal Disease and intends to use GORE® ACUSEAL Vascular Graft device for arteriovenous (AV) access.\n2. Age ≥18 years at time of Informed Consent Form (ICF) signature.\n3. Willingness of the patient to adhere to institutional standard of care follow-up.\n4. Informed Consent Form (ICF) is signed by the patient.\n5. The patient is currently on hemodialysis or intended to begin hemodialysis immediately following placement of the GORE® ACUSEAL Vascular Graft device or up to 30 days following placement of the device.\n6. The patient has a reasonable expectation of remaining on hemodialysis for 12 months.\n\nExclusion Criteria:\n\n1. The patient currently has a known or suspected systemic infection.\n2. The patient is pregnant or breastfeeding.\n3. The patient had a separate interventional or surgical vascular procedure within the study limb within 30 days prior to treatment with the GORE® ACUSEAL Vascular Graft device.\n4. The patient had a previous documented (via imaging technique) and unsuccessfully treated ipsilateral central venous stenosis.\n5. The patient is currently taking maintenance corticosteroids and immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (\\> 10 mg), cyclosporine, tacrolimus, or cyclophosphamide.\n6. The patient has a known hypercoagulability or bleeding disorder.\n7. The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to Heparin.\n8. The patient is enrolled in an investigational study.\n9. The patient has been previously enrolled in this registry.\n10. The patient is currently being considered for a live donor kidney transplant (living donor either related or unrelated to patient).\n11. The patient has life expectancy less than 2 years.","ALL","18 Years",{"count":140,"type":141},72,"ESTIMATED","24 Months","OBSERVATIONAL","The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. The main questions it aims to answer are:\n\n* Safety: Freedom from device-related infection adverse events at 24 months from device implant\n* Performance: Secondary patency at 24 months from device implant.\n\nParticipants, after informed consent is obtained, will be implanted with GORE® ACUSEAL Vascular Graft and followed for 24 months in standard of care, to evaluate safety and performance of the device.",[146,147],"Chronic Kidney Diseases","End Stage Renal Disease on Dialysis",[149,146,150,151,152],"Post-Market Clinical Follow-Up","End Stage Renal Disease","Hemodialysis","vascular graft","2025-07-08",{"date":155,"type":156},"2025-07-09","ACTUAL",{"date":158,"type":156},"2024-01-12",{"date":160,"type":141},"2027-10-27",{"name":5,"class":6},5]