[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498798":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":29,"locations":38,"responsibleParty":54,"collaborators":10,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":10,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Karolinska University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard EVAR",null,"Infrarenal abdominal aortic aneurysms treated with standard EVAR off-the-shelf devices.",[13],"Procedure: Standard Endovascular aneurysm repair (sEVAR)",{"label":15,"type":10,"description":16,"interventionNames":17},"Complex EVAR","Paravisceral aortic aneurysms treated with fenestrated or branched EVAR devices.",[18],"Procedure: Complex Endovascular Aneurysm Repair (cEVAR)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"PROCEDURE","Standard Endovascular aneurysm repair (sEVAR)","Standard EVAR treatment with Medtronic Endurant IIs (Medtronic, Inc. - Minneapolis, Minnesota), Gore Excluder AAA (W. L. Gore \\& Associates, Inc. - Newark, Delaware), Gore Excluder Conformable AAA (W. L. Gore \\& Associates, Inc. - Newark, Delaware), Cook Zenith Flex (Cook Medical, Inc. - Bloomington, Indiana).",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Complex Endovascular Aneurysm Repair (cEVAR)","Complex EVAR treatment with custom made devices (CMD's) from Cook Medical (Cook Medical, Inc. - Bloomington, Indiana) including fenestrated or branched devices or off-the-shelf T-branch device (Cook Medical, Inc. - Bloomington, Indiana).",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Rebecka Hultgren, MD, PhD","CONTACT","+46 8 123 700 00","rebecka.hultgren@ki.se",{"name":36,"role":32,"phone":33,"phoneExt":10,"email":37},"Mårten Huss, MD","marten.huss@ki.se",[39],{"facility":5,"status":40,"city":41,"state":10,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Stockholm","17176","Sweden","SE",{"type":46,"coordinates":47},"Point",[48,49],18.06871,59.32938,{"lat":49,"lon":48},[52],{"name":36,"role":32,"phone":53,"phoneExt":10,"email":37},"+46 8 123 70000",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Rebecka Hultgren","Adjunct professor","100498798","qol-after-complex-endovascular-aortic-repair-100498798",false,"NCT05774938","QoL After Complex Endovascular Aortic Repair","Inclusion Criteria:\n\n* Men and women.\n* Any age (≥18 years)\n* Planned (elective) endovascular treatment by EVAR, FEVAR or BEVAR.\n* Patients previously treated by EVAR which are planned for an adjunct fenestrated cuff will not be included in the basic analysis, but included and analysed separately.\n\nExclusion Criteria:\n\n* Inability to understand and\u002For respond to the study questionnaires that are in Swedish.\n* Inability to provide an informed consent for participation in the study, orally or in writing (This may be due to linguistic or cognitive limitation).\n* Participation in other ongoing studies concerning quality of life.","ALL","18 Years",{"count":67,"type":68},90,"ESTIMATED","OBSERVATIONAL","The goal of this prospective observational cohort study is to compare health related quality of life in patients with abdominal aortic aneurysms treated by either standard or complex EVAR (endovascular aneurysm repair) devices. The main questions it aims to answer are:\n\n* Compare differences between the physical scores from the preoperative to the postoperative settings between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-\u002FBEVAR)\n* To compare long-term physical scores postoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-\u002FBEVAR) at one year.\n* To explore at which time points (if ever) patients treated with standard-EVAR and nonstandard endovascular aortic repair (F-\u002FBEVAR) have restored or normalized physical scores measured by SF-12, measured at 30 days, 6 months, 1 and 3 years.\n\nParticipants will be asked to fill out forms pre- and postoperatively with regards to health related quality of life.\n\nThe different groups for comparison will be either standard EVAR for infrarenal aortic aneurysms or complex EVAR (fenestrated or branched) for paravisceral aortic aneurysms (PVAAA).",[72,73,74],"Quality of Life","Aortic Aneurysm","Aortic Aneurysm, Abdominal",[76,77,78,79,80,81],"Endovascular aneurysm repair","Pararenal aortic aneurysm","Quality of life","Paravisceral aortic aneurysm","Fenestrated endovascular aortic repair","Branched endovascular aortic repair","2025-04-08",{"date":84,"type":85},"2025-04-10","ACTUAL",{"date":87,"type":85},"2023-02-28",{"date":89,"type":68},"2030-01",{"name":5,"class":6},1]