[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541395":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":54,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":11,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Xeltis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"aXess-E conduit","EXPERIMENTAL",null,[13],"Device: aXess-E conduit",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DEVICE","The aXess-E conduit is a sterile, regenerative biodegradable polymer-based vascular conduit, consisting of a tubular structure with a 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The aXess-E conduit is able to support both straight and loop configurations and may be implanted in the upper arm and forearm.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Eliane Schutte","CONTACT","+31 40 751 7614","clinical@xeltis.com",[26,41],{"facility":27,"status":28,"city":29,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Hospital de Santa Maria","RECRUITING","Lisbon","Portugal","PT",{"type":33,"coordinates":34},"Point",[35,36],-9.1498,38.72509,{"lat":36,"lon":35},[39],{"name":40,"role":22,"phone":11,"phoneExt":11,"email":11},"Augusto Ministro",{"facility":42,"status":28,"city":43,"state":11,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":50,"contacts":51},"Kliničko bolnički centar Zvezdara Klinika za Interne Bolesti","Belgrade","Serbia","RS",{"type":33,"coordinates":47},[48,49],20.46513,44.80401,{"lat":49,"lon":48},[52],{"name":53,"role":22,"phone":11,"phoneExt":11,"email":11},"Marijana Bogosavac",{"type":55,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100541395","xeltis-hemodialysis-access-axess-conduit-axess-e-study-100541395",false,"NCT06329310","Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study","Prospective, Non-randomized Feasibility Study to Confirm the Safety and Performance of the Xeltis Hemodialysis Access Conduit: aXess-E Study","Inclusion Criteria:\n\n1. Subjects with end-stage renal disease (ESRD) who require placement of an Arteriovenous Graft (AVG) in the upper extremity to start or maintain hemodialysis therapy\n2. At least 18 years of age at screening\n3. Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess-E conduit\n4. The patient has been informed about the nature of the study, understands and agrees to its provisions, and has personally provided written informed consent\n5. The patient has been informed and agrees to pre- and post- procedure follow-up\n6. Life expectancy of at least 12 months\n\nExclusion Criteria:\n\n1. History or evidence of severe cardiac disease (New York Heart Association (NYHA) Functional Class IV and\u002For Ejection Fraction (EF) \\\u003C25%), myocardial infarction within six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina\n2. Uncontrolled or poorly controlled diabetes\n3. Abnormal blood values that could influence patient recovery and or\u002F conduit hemostasis\n4. Reduced liver function, defined as: \\>2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) \\>1.5 or prothrombin time (PT) \\>18 seconds\n5. Any active local or systemic infection\n6. Known heparin-induced thrombocytopenia\n7. Known active bleeding disorder and\u002For any coagulopathy or thromboembolic disease\n8. Allergies to study device (nitinol) or agents\u002Fmedication, such as contrast agents or aspirin, that can't be controlled medically\n9. Anticipated renal transplant within 6 months\n10. Known or suspected central vein obstruction on the side of planned conduit implantation\n11. Previous dialysis access conduit in the operative limb unless the aXess-E conduit can be placed more proximally than the previous failed conduit\n12. Previous enrolment in this study\n13. Subject is participating in another study\n14. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives\n15. Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit\n\nIntra-operative exclusion criteria:\n\n1\\. Unsuitable anatomy to implant the aXess-E conduit (e.g. target vein and\u002For artery diameter smaller than anticipated; severe calcification)","ALL","18 Years",{"count":66,"type":67},20,"ESTIMATED","INTERVENTIONAL",[70],"NA","A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.",[73],"End Stage Renal Disease","2025-04-01",{"date":76,"type":77},"2025-04-04","ACTUAL",{"date":79,"type":77},"2024-12-16",{"date":81,"type":67},"2026-12",{"name":5,"class":6},2]