[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648130":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":26,"collaborators":11,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":11,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":11,"enrollmentInfo":37,"targetDuration":11,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":11,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":11},{"fullName":5,"class":6},"Xeltis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"XPAD","EXPERIMENTAL",null,[13],"Device: XPAD conduit",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","XPAD conduit","The XPAD bypass conduit is a sterile, restorative biodegradable polymer-based vascular conduit, consisting of a tubular structure with a 33cm length and 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The XPAD conduit is in a straight configuration and may be implanted in the lower limb for elective bypass surgery.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Sandra Kohler","CONTACT","+31 (0) 6 55 55 57 14","sandra.kohler@xeltis.com",{"type":27,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100648130","xpad-european-feasibility-study-100648130",false,"NCT07716020","XPAD European Feasibility Study","Prospective, Non-randomized, European Feasibility Clinical Study to Assess the Safety and Performance of the Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit.","Inclusion Criteria:\n\n1. Participants with peripheral artery occlusion who require elective lower-limb bypass surgery\n2. Participant has Rutherford grade 3 or 4 occlusive vascular disease and TASC C or D lesions.\n3. At least 18 years of age at screening\n4. Suitable anatomy while avoiding joints (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)\n5. Participant has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent\n6. Participant 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. Participant requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.\n2. Stroke or myocardial infarction event within 6 weeks of the procedure or evidence of prior massive stroke (Modified Rankin Scale 3 or above)\n3. History of acute arterial occlusion requiring an emergent intervention within the last 12 months\n4. Severe chronic renal insufficiency (serum creatinine \\>2.5 mg\u002FdL) or undergoing hemodialysis\n5. Previous renal transplant\n6. Uncontrolled arterial hypertension (BP \\>200 mmHg) at 2 successive readings\n7. Uncontrolled or poorly controlled diabetes\n8. Abnormal blood values that could influence participant recovery and or\u002F graft hemostasis\n9. 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\n10. Any active local or systemic infection\n11. Known heparin- induced thrombocytopenia, active bleeding disorder and\u002For any coagulopathy or thromboembolic disease\n12. Allergies to study device (nitinol) or agents\u002Fmedication, such as contrast agents, aspirin or NOACs, that can't be controlled medically\n13. Previous enrolment in this study\n14. Participant is participating in another study\n15. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives\n16. 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":38,"type":39},15,"ESTIMATED","INTERVENTIONAL",[42],"NA","A prospective, single arm, non-randomized European feasibility study to evaluate the safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective lower-limb, above or below the knee, bypass surgery.",[45],"Peripheral Arterial Disease","NOT_YET_RECRUITING","2026-07-20",{"date":49,"type":50},"2026-07-21","ACTUAL",{"date":52,"type":39},"2026-12",{"date":54,"type":39},"2032-12",{"name":5,"class":6}]