[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xeltis\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100589228","xeltis-peripheral-artery-disease-xpad-bypass-conduit-early-feasibility-study-100589228",false,"NCT06951685","Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study","Prospective, Non-randomized, Early Feasibility Clinical Study to Assess the Feasibility of the Novel Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit","Inclusion Criteria:\n\n1. Subjects with femoral artery occlusion who require elective above-knee femoral popliteal bypass surgery\n2. Patient has Rutherford grade 3, 4, or 5 occlusive vascular disease and TASC C or D lesions. Rutherford grade 5 may be included with a wound, ischemia and foot infection (WiFi) classification of up to grade 2, provided there are two outflow vessels with at least one reaching the pedal arch\n3. At least 18 years of age at screening\n4. Suitable anatomy (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)\n5. Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent\n6. Patient has been informed and agrees to pre- and post-procedure follow-up, including follow-up angiography\n7. Life expectancy of at least 24 months\n\nExclusion Criteria:\n\n1. Subject requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.\n2. Presence or history of bypass in the diseased limb\n3. Subject requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts\n4. Stroke or myocardial infarction event within 6 weeks of the procedure or evidence of prior massive stroke (Modified Rankin Scale 3 or above)\n5. History of acute arterial occlusion requiring an emergent intervention\n6. Severe chronic renal insufficiency (serum creatinine \\>2.5 mg\u002FdL) or undergoing hemodialysis\n7. Previous renal transplant\n8. Uncontrolled arterial hypertension (BP \\>200 mmHg) at 2 successive readings\n9. Uncontrolled or poorly controlled diabetes\n10. Abnormal blood values that could influence patient recovery and or\u002F graft hemostasis\n11. 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\n12. Any active local or systemic infection\n13. Known heparin-induced thrombocytopenia\n14. Known active bleeding disorder and\u002For any coagulopathy or thromboembolic disease\n15. Allergies to study device (nitinol) or agents\u002Fmedication, such as contrast agents or aspirin, that can't be controlled medically\n16. Previous enrolment in this study\n17. Subject is participating in another study\n18. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives\n19. 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 XPAD conduit (e.g. target vessel diameter smaller than anticipated; severe calcification)","ALL","18 Years",{"count":19,"type":20},6,"ESTIMATED","INTERVENTIONAL",[23],"NA","A prospective, single arm, non-randomized early feasibility study to evaluate the preliminary safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective above-knee femoral popliteal bypass surgery.",[26],"Peripheral Artery Occlusive Disease","RECRUITING","2025-07-09",{"date":30,"type":31},"2025-07-15","ACTUAL",{"date":33,"type":31},"2025-05-02",{"date":35,"type":20},"2028-09",{"name":37,"class":38},"Xeltis","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":5},"100541395","xeltis-hemodialysis-access-axess-conduit-axess-e-study-100541395","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)",{"count":48,"type":20},20,[23],"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.",[52],"End Stage Renal Disease","2025-04-01",{"date":55,"type":31},"2025-04-04",{"date":57,"type":31},"2024-12-16",{"date":59,"type":20},"2026-12",{"name":37,"class":38},""]