[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593338":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":38,"responsibleParty":86,"collaborators":32,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":32,"enrollmentInfo":98,"targetDuration":32,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Archo Medical S.A","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Endovascular Implant of iHub Iliac Stent-Graft for Treatment of Iliac Artery Aneurysms","EXPERIMENTAL","Eligible participants with an iliac artery aneurysm, or aneurysms of the iliac arteries, who have iliac\u002Ffemoral access compatible with the delivery systems, and a previously implanted or concurrently implanted bifurcated aortic stent-graft with branch diameters between 14 and 16 mm, will undergo endovascular surgery for aneurysm treatment using the iHub device",[13],"Device: Endovascular Iliac Branch Stent-Graft Implantation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Endovascular Iliac Branch Stent-Graft Implantation","Implantation of a self-expanding dual-lumen iliac branch stent-graft designed to treat iliac artery aneurysms while preserving perfusion to the internal iliac artery. The device enables connection to bridging stent-grafts directed to both the internal and external iliac arteries. It is compatible with previously implanted or concurrently implanted bifurcated aortic stent-grafts with branch diameters between 14 and 16 mm. The stent-graft is delivered endovascularly using a low-profile catheter-based system under fluoroscopic guidance. Once in position, the device is deployed via a controlled pull-back release mechanism. Radiopaque markers assist in precise alignment and facilitate the placement of bridging components.",[9],[21],"Implantation of an Endovascular Iliac Branch Stent-Graft for Iliac Aneurysm Repair",[23],{"name":24,"affiliation":25,"role":26},"Grace C Mulatti, PI","Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo- FMUSP","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Suzan X Lima","CONTACT","5548988092141",null,"regulatorio@archomedical.com",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},"Marcela M Dutra","5554898004664","mdutra.regulatorio@gmail.com",[39,64],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Instituto de Ensino e Pesquisa Dr. Irineu May Brodbeck - Hospital Baía Sul S\u002FA","RECRUITING","Florianópolis","Santa Catarina","88020210","Brazil","BR",{"type":48,"coordinates":49},"Point",[50,51],-48.54917,-27.59667,{"lat":51,"lon":50},[54,58,60,61],{"name":55,"role":30,"phone":56,"phoneExt":32,"email":57},"Cristiano T Bortoluzzi","+5548988426165","cristianobortoluzzi@me.com",{"name":35,"role":30,"phone":59,"phoneExt":32,"email":37},"+5548998004664",{"name":55,"role":26,"phone":32,"phoneExt":32,"email":32},{"name":62,"role":63,"phone":32,"phoneExt":32,"email":32},"Anna L Driessenn","SUB_INVESTIGATOR",{"facility":65,"status":66,"city":67,"state":67,"zip":68,"country":45,"countryCode":46,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP","NOT_YET_RECRUITING","São Paulo","05403-000",{"type":48,"coordinates":70},[71,72],-46.63611,-23.5475,{"lat":72,"lon":71},[75,79,83,84],{"name":76,"role":30,"phone":77,"phoneExt":32,"email":78},"Grace C Mulatti","5511983770330","grace.mulatti@hc.fm.usp.br",{"name":80,"role":30,"phone":81,"phoneExt":32,"email":82},"Miguel G F","+5575999289775","miguelfernandez212@hotmail.com",{"name":76,"role":26,"phone":32,"phoneExt":32,"email":32},{"name":85,"role":63,"phone":32,"phoneExt":32,"email":32},"Nelson D Luccia",{"type":87,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100593338","ihub-stent-graft-for-iliac-artery-aneurysms-safety-performance-and-effectiveness-study-100593338",false,"NCT07005141","iHub Stent-Graft for Iliac Artery Aneurysms: Safety, Performance, and Effectiveness Study","iHub no Tratamento de Aneurismas ilíacos: Avaliação da Segurança, Desempenho e Eficácia.","TriHub","Inclusion Criteria: Sign the Informed Consent Form (ICF); Are ≥ 18 years of age;\n\nMeet at least one of the following criteria for iliac artery aneurysm:\n\n1. Common iliac artery aneurysm ≥ 25 mm in diameter;\n2. Aneurysm growth of 5 mm or more within the last six months;\n3. Maximum aneurysm diameter exceeds 1 to 1.5 times the normal arterial segment diameter, that is ≥ 25 mm maximum diameter;\n4. Saccular aneurysm greater than 20 mm;\n5. Abdominal aortic aneurysm with extension into the common iliac arteries of less than 20 mm;\n\nHave a previously implanted aorto-bi-iliac stent-graft with branch diameter between 14 and 16 mm;\n\nHave iliac\u002Ffemoral access vessel morphology compatible with vascular access techniques, placement systems, devices, and\u002For accessories;\n\nAre classified as ASA physical status I to III. ASA IV patients may be included if their life expectancy is greater than one year;\n\nAre able and willing to comply with follow-up requirements during the 360-day post-implant period.\n\n\\-\n\nExclusion Criteria: Pregnant women, women of childbearing potential, or breastfeeding women;\n\nA dissection, rupture, or complex vascular lesion due to trauma;\n\nNeed for emergency surgery;\n\nContraindication to angiography;\n\nDiffuse atherosclerotic disease in any common iliac artery reducing its diameter to \\\u003C 4 mm;\n\nCongenital abnormalities where stent placement would obstruct a major artery. Such abnormalities must be assessed prior to treatment;\n\nUnstable angina;\n\nClass III obesity (BMI ≥ 40 kg\u002Fm²) or other clinical conditions that severely limit radiographic visualization of the aorta;\n\nConnective tissue disease (e.g., Marfan or Ehlers-Danlos syndrome);\n\nHypercoagulable state;\n\nContraindication to anticoagulation therapy;\n\nAcute or chronic renal insufficiency (serum creatinine \\> 2.0 mg\u002FdL);\n\nLife expectancy of less than one year;\n\nPresence of a systemic infection that could increase the risk of endovascular device infection;\n\nKnown sensitivity or allergy to device materials: expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene (FEP), or nickel-titanium (Nitinol).\n\n\\-","ALL","18 Years",{"count":99,"type":100},10,"ESTIMATED","INTERVENTIONAL",[103],"NA","The goal of this clinical trial is to evaluate the safety, performance, and Preliminary effectiveness of the iHub endoprosthesis system in treating iliac artery aneurysms in adult patients requiring endovascular repair. The study population includes both male and female adults over 18 years of age who meet the inclusion criteria for endovascular treatment of iliac artery aneurysms.\n\nThe main questions it aims to answer are:\n\nIs the iHub stent-graft system safe for use in patients with iliac artery aneurysms? Does the iHub system demonstrate adequate technical performance and sustained patency over a 12-month follow-up period? Participants will undergo a minimally invasive endovascular procedure to implant the iHub endoprosthesis system. The device is designed to preserve internal iliac artery flow while excluding the aneurysmal segment.\n\nParticipants will:\n\nUndergo pre-screening evaluations including clinical examination, laboratory tests, and imaging (CT angiography and ultrasound).\n\nUndergo endovascular implantation of the iHub device. Attend follow-up visits at 30, 90, 180, and 360 days post-implant to assess clinical outcomes and device performance.",[106,107],"Iliac Aneurysm","Aortic Aneurysm, Abdominal",[109,110,111,112,113,114],"iliac aneurysm","iHub","stentgraft system","endovascular treatment","abdominal aortic aneurysm","EVAR","2026-06-11",{"date":117,"type":118},"2026-06-15","ACTUAL",{"date":120,"type":118},"2026-05-26",{"date":122,"type":100},"2028-12",{"name":5,"class":6},2]