[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639731":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":45,"collaborators":11,"id":48,"slug":11,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":49,"sex":53,"minAge":54,"maxAge":11,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":11,"overallStatus":64,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Abdominal aortic aneurysm repair","EXPERIMENTAL",null,[13],"Device: Physician-Modified Terumo Treo Abdominal Stent-Graft System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Physician-Modified Terumo Treo Abdominal Stent-Graft System","A physician modified Terumo Treo abdominal stent-graft system will be used during repair surgery for type II, III and IV thoracoabdominal aortic aneurysms.",[9],[21],{"name":22,"affiliation":5,"role":23},"Young Erben, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Pia Geisselmaier","CONTACT","904-953-2077","Geisselmaier.PiaJulia@mayo.edu",[31],{"facility":5,"status":11,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Jacksonville","Florida","32224","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-81.65565,30.33218,{"lat":41,"lon":40},[44],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},{"type":23,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Young M. Erben","Principal Investigator","100639731",false,"NCT07611968","Prospective Evaluation of Physician Modified Endografts for Aortic Disease","Inclusion Criteria:\n\n* An aneurysm with a maximum diameter of \\>5.5cm in males and \\>5.0cm in females in diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements\n* Aneurysm with a history of growth \\> 0.5 cm in 6 months\n* Saccular aneurysm deemed at significant risk for rupture\n* Symptomatic aneurysm\n* Extent of aorta to be treated: type II, III and IV thoracoabdominal.\n* Subject is at high-risk of morbidity and mortality with open surgical repair as defined by FEV1 of \\\u003C1 liter or uncorrectable coronary disease, frailty, hostile abdomen.\n* Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit.\n* Non-aneurysmal aortic segment proximal to the aneurysm (neck) with a:\n* Minimum neck length of 15mm\n* Diameter in the range of 17-32\n* Minimum branch vessel diameter greater than 5 mm\n* Iliac artery distal fixation site\n* An inside diameter of 8mm - 13mm and a length of ≥ 10mm or\n* an inside diameter of \\> 13mm - 20mm and a length of ≥ 15mm\n* Age: ≥50 years old\n\nExclusion Criteria:\n\n* Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis\n* Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site\n* Unwilling to comply with the follow-up schedule\n* Inability or refusal to give informed consent by subject or legal representative\n* Subject is pregnant or breastfeeding\n* Ruptured aneurysms\n* Prior aortic repair\n* Patient is eligible for treatment with an FDA-approved marketed device and patient can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution.\n* Known sensitivities or allergies to the materials of construction of the devices, including nitinol, polyester, PTFE, stainless steel, platinum\u002Firidium, tantalum markers.\n* Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed\n* Uncorrectable coagulopathy\n* Body habitus that would inhibit x-ray visualization of the aorta or exceed the safe capacity of the equipment\n* Subject has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \\\u003C 30 days of endovascular repair\n* Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)\n* Systemic or local infection that may increase the risk of endovascular graft infection\n* Baseline creatinine greater than 2.0 mg\u002FdL\n* Thrombus or excessive calcification within the neck of the aneurysm\n* Branch stenosis \\>50% not amenable to endovascular preparation","ALL","50 Years",{"count":56,"type":57},20,"ESTIMATED","INTERVENTIONAL",[60],"NA","The purpose of this research is to assess safety and preliminary effectiveness of the Physician-Modified Terumo Treo Abdominal Stent-Graft System.",[63],"Aortic Aneurysm","NOT_YET_RECRUITING","2026-05-21",{"date":67,"type":68},"2026-05-28","ACTUAL",{"date":70,"type":57},"2026-07-15",{"date":72,"type":57},"2028-07-15",{"name":5,"class":6},1]