[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aorto-iliac-aneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aorto-iliac-aneurysm":58},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100600353","evaluation-of-cost-effectiveness-of-iliac-branch-endoprostheses-100600353",false,"NCT07096388","Evaluation Of Cost-Effectiveness Of Iliac Branch Endoprostheses","Evaluation Of Cost-Effectiveness Of Iliac Branch Endoprostheses: A Multi-Center, Retrospective-Prospective, Observational Study\u002F Eunet-Hta Core Model","ECO-IBE","Inclusion Criteria:\n\n* Patients affected by an aorto-iliac aneurysm who received an elective open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft) or endovascular repair (with Iliac Branch Endoprosthesis)\n* Adult patients ≥18 years\n* Patients able to understand and sign the informed consent approved by the Ethics Committee of San Raffaele Hospital\n\nExclusion Criteria:\n\n* Patients treated with a hybrid approach (concomitant open surgical and endovascular treatment)\n* Patients treated with other endovascular techniques besides branched technology (e.g., physician-modified endografts, parallel grafts)\n* Patients already submitted to prior open or endovascular repair for aorto-iliac aneurysm\u002Fprior aorto iliac aneurysm sac embolization\n* Patients treated in urgent\u002Femergent setting","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","The study is a multi-center, voluntary observational study on an ambispective cohort of patients treated between January 2018 and December 2025.The study aims to enroll 300 patients (around 200 patients in the retrospective cohort and 100 patients in the prospective cohort). The study will include adult patients (≥ 18 years) of either sex submitted to open surgical repair or endovascular repair of an aorto-iliac aneurysm.The procedures and clinical evaluation included in this study correspond to current clinical practice. The assignment of the patient to a given diagnostic and\u002For therapeutic procedure is not linked to random allocation but is part of the ordinary therapeutic strategy provided for that patient; full freedom of choice as regards to the allocation of the patient to the diagnostic and therapeutic procedures is guaranteed for each case. Follow-up visits substantially correspond to current clinical practice or to the requirements of national and\u002For international guidelines. The administration of questionnaires, interviews, diaries, surveys of health economics and pharmacoeconomics, subjective assessments by the patient on their state of health, assessment scales and blood chemistry tests, the use of which is justified by the rationale of the study. The objectives of the study are the comparison of perioperative and late clinical success of repair procedure and comparison of cost-effectiveness of two precedures.",[25],"Aorto-iliac Aneurysm",[27,28,29,30],"endovascular repair","aorto-iliac aneurysm","iliac branch endoprotheses","open surgical repair","NOT_YET_RECRUITING","2026-03-24",{"date":34,"type":35},"2026-03-25","ACTUAL",{"date":37,"type":21},"2026-05-01",{"date":39,"type":21},"2030-03-01",{"name":41,"class":42},"Prof. Andrea Kahlberg","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100616322","assessment-of-gore-excluder-ibe-plus-stent-graft-performance-in-patients-undergoing-endovascular-iliac-revascularization-100616322","NCT07304102","Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization","Primary Arm Inclusion Criteria\n\nThe subject is \u002F has:\n\n1. The target lesion and surrounding vasculature are amenable to treatment with IBE Plus system requirements:\n\n   1.1. Common iliac artery to be treated must have a common iliac diameter ≥ 25 mm with or without concomitant abdominal aortic aneurysm 1.2. Minimum diameter ≥ 12 mm within the proximal implantation zone of IBE Plus as assessed by flow lumen; calcium excluded 1.3. Intended treatment length must be ≥ 100 mm in unilateral application or a combination of ≥ 100 mm and ≥ 150 mm in bilateral application 1.4. The planned distal target landing zone within the internal iliac artery is within the trunk of the internal iliac artery with at least 15 mm of seal zone 1.5. Iliac vasculature meets anatomical specifications for selected VBX Stent Graft(s)\n2. Aortoiliac vasculature meets anatomical specifications for selected EXC or EXCC Devices\n3. Informed Consent Form (ICF) is signed by subject\n4. Subject is capable of complying with protocol requirements, including follow-up\n5. Life expectancy \\> 2 years\n6. Age ≥ 22 years at time of informed consent signature\n7. Male or infertile female\n\nSecondary Arm Inclusion Criteria\n\nThe subject is \u002F has:\n\n1. Present with any one of the following treatment indications:\n\n   1.1. The subject has a confirmed Type Ib endoleak of a previously implanted Gore EVAR device where its distal portion within the common iliac artery has a luminal diameter of at least 12 mm. Minimum diameter of ≥ 12 mm within the proximal implantation zone of IBE Plus as assessed by flow lumen; calcium excluded 1.2. The subject has documented diameter growth of the common iliac artery of at least ≥ 5 mm in the presence of a previously implanted Gore EVAR device where its distal portion within the common iliac artery has a luminal diameter of at least 12 mm. The planned distal target landing zone within the internal iliac artery is within the trunk of the internal iliac artery with at least 15 mm of seal zone\n2. Aortoiliac vasculature meets anatomical specifications for selected EXC or EXCC Devices\n3. Informed Consent Form (ICF) is signed by subject\n4. Subject is capable of complying with protocol requirements, including follow-up\n5. Life expectancy \\> 2 years\n6. Age ≥ 22 years at time of informed consent signature\n7. Male or infertile female\n\nPrimary Arm and Secondary Arm Exclusion Criteria\n\nThe subject is \u002F has:\n\n1. Mycotic or ruptured aneurysm\n2. ASA class V (moribund patient not expected to live 24 hours with or without operation)\n3. Renal insufficiency defined as creatinine \\> 1.8 mg\u002FdL or undergoing dialysis\n4. NYHA class IV\n5. Dissected, heavily calcified, or heavily thrombosed landing zone(s)\n6. Tortuous or stenotic iliac and\u002For femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access\n7. Participating in another investigational drug or medical device study within one year of study enrollment\n8. An active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication) that may place the patient at increased risk of endovascular infection. Subjects with a chronic infection (such as HIV, Hepatitis C, etc.) that is well controlled under their current treatment regimen may be eligible\n9. Degenerative connective tissue disease, e.g., Marfan's or Ehler-Danlos Syndrome\n10. Planned concomitant surgical procedure or major surgery within 30 days of treatment date\n11. History of drug abuse, e.g., cocaine or amphetamine, within 1 year of treatment\n12. Known sensitivities or allergies to the device materials","22 Years",{"count":51,"type":21},100,"INTERVENTIONAL",[54],"NA","The IBE 25-05 study will be a prospective, non-randomized, multicenter, interventional two arm evaluation designed to assess the safety and effectiveness of the GORE® EXCLUDER® IBE Plus Stent Graft in patients with common iliac artery aneurysm (CIAA) or aorto-iliac aneurysm (AIAA) disease.",[57,58],"Common Iliac Artery Aneurysm","Aorto Iliac Aneurysm",[60,61,62,63,64,65,66],"EVAR Revision","EVAR","Endovascular Aneurysm Repair","AIAA","CIAA","IBE","Iliac Aneurysm","2025-12-23",{"date":69,"type":35},"2025-12-26",{"date":71,"type":21},"2026-09",{"date":73,"type":21},"2032-08",{"name":75,"class":76},"W.L.Gore & Associates","INDUSTRY"]