[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"FCRE (Foundation for Cardiovascular Research and Education)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100401142","short-neck-aaa-randomized-trial---esar-and-fevar-socrates-100401142",false,"NCT04503395","ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES","Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck","SOCRATES","Inclusion Criteria:\n\n* Subject is \\>18 years old\n* Subject is scheduled for primary treatment of the abdominal aortic aneurysm with a non-aneurysmal infrarenal aortic sealing zone proximal to the aneurysm that is sufficiently healthy for a proximal neck length that is at least 4mm and not more than15 mm and has a circumferential minimum sealing zone length of 8 mm\n* Subject is not a candidate for safe, effective and durable standard EVAR due to challenging anatomical criteria as confirmed by the Core Lab screening\n* Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.\n* Subject has provided written informed consent\n\nCT Angiographic Inclusion Criteria\n\n* Subject meets the other anatomical requirements according to the locally applicable Endurant II\u002FIIs stent graft system, Heli-FX EndoAnchor system, Terumo Fenestrated Anaconda (available in EU only) and\u002For Cook Zenith Fenestrated Graft Instructions for Use\n* Proximal neck length of the aorta within 4-15mm and a minimum circumferential sealing zone of 8mm\n* Aortic neck diameter from 19 to 31mm\n* Infrarenal neck angulation ≤45°\n\nExclusion Criteria:\n\n* Subject is participating in a concurrent study which may confound study results\n* Subject has a life expectancy \\\u003C2 year\n* Subject is female of childbearing potential in whom pregnancy cannot be excluded\n* Subject with eGFR \\\u003C30 mL\u002Fmin\u002Fm2 (KDOQI classification - exclude class IV and above) and or on dialysis\n* Subject with a MI or CVA within 3 months prior to index procedure\n* Subject with known Connective Tissue Disease\n* Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to post-treatment\n* Subject who has undergone prior endovascular or open surgical treatment for abdominal aortic aneurysm\n* Subject requires emergent aneurysm treatment, for example, trauma or rupture\n* Subject has a known hypersensitivity or allergies to study device implant material\n* Subject has an aneurysm that is:\n\n  * Suprarenal, pararenal, or thoracoabdominal\n  * Mycotic\n  * Inflammatory\n  * Pseudoaneurysm\n* Subject is presenting with thrombus or calcification of the proximal aneurysm neck: circumferential \\>50%\n* Pre-op stenosis of the renal arteries \\> 50%\n* Subject has active infection or history of COVID-19. History of COVID-19 is defined as availability of positive COVID-19 test with sequelae or hospitalization for treatment of COVID-19.","ALL","18 Years",{"count":20,"type":21},204,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).",[27],"Aortic Aneurysm, Abdominal","RECRUITING","2026-05-20",{"date":31,"type":32},"2026-05-22","ACTUAL",{"date":34,"type":32},"2021-05-21",{"date":36,"type":21},"2032-06-01",{"name":38,"class":39},"FCRE (Foundation for Cardiovascular Research and Education)","OTHER",33,""]