[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546387":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":18,"responsibleParty":42,"collaborators":44,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":18,"enrollmentInfo":64,"targetDuration":18,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":78,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":18},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early EVAR","EXPERIMENTAL","Endovascular aneurysm repair within 2 months of randomisation using any licensed infrarenal aortic endograft within the manufacturer's instructions for use.",[13],"Device: EVAR",{"label":15,"type":16,"description":17,"interventionNames":18},"Surveillance","NO_INTERVENTION","Regular imaging surveillance (ultrasound or CT) of aneurysm diameter until the diameter reaches 5.5 cm, develops symptoms of impending rupture or ruptures. The delayed repair may be by any method.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","EVAR","Catheter based insertion of aortic endograft via iliac or femoral arteries",[9],[26],"infrarenal aortic endograft",[28],{"name":29,"affiliation":30,"role":31},"Alison Halliday, FRCS","University of London","STUDY_CHAIR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Rebecca Ruiz","CONTACT","+44735250468","warriors@imperial.ac.uk",{"name":39,"role":35,"phone":40,"phoneExt":18,"email":41},"Anna-Louise Pouncey, MRCS, PhD","+447912651686","a.pouncey@imperial.ac.uk",{"type":43,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[45,47,49,52],{"name":46,"class":6},"University College, London",{"name":48,"class":6},"University of Leicester",{"name":50,"class":51},"St Georges University Hospital","UNKNOWN",{"name":53,"class":6},"University of Southern Denmark","100546387","early-endovascular-repair-versus-surveillance-for-women-with-small-abdominal-aortic-aneurysm-100546387",false,"NCT06394271","Early Endovascular Repair Versus Surveillance for Women With Small Abdominal Aortic Aneurysm","WARRIORS Trial and Registry","WARRIORS","Inclusion Criteria:\n\n* female sex\n* age ≥50 years\n* infra-renal abdominal aortic aneurysm with a maximum infrarenal aortic anterior-posterior diameter 4.0-5.4 cm, aneurysm, measured on ultrasonography or the centreline orthogonal diameter on Computed Tomography (CT) scan when this is the discovery imaging mode,\n* Local assessment that arterial morphology is suitable for EVAR within manufacturer's IFU for any licensed infrarenal endograft, including those with concomitant common iliac aneurysm(s), provided the device is landed in the iliac arteries, without coverage of patent internal iliac arteries.\n* Rockwood frailty score \\\u003C7.\n\nExclusion Criteria:\n\n* Male sex\n* aneurysm of the infrarenal aorta of \\\u003C4.0 or \\>5.4cm\n* infrarenal aneurysm not meeting IFU for any specific licensed endograft for standard EVAR\n* inability to give informed consent\n* previous abdominal aortic surgery\n* age \\\u003C50 years\n* concomitant thoracic aortic aneurysm of \\>4.0cm diameter\n* excessive frailty (Rockwood frailty score 7 or more)\n* life expectancy \\\u003C2 years (in the opinion of the site principal investigator)\n* severe contrast allergy not amenable to steroid\u002Fantihistamine pretreatment (e.g., anaphylaxis)\n* those considered unlikely to comply with follow-up\n* concomitant common iliac artery aneurysm unless: a) the arterial morphology is within the IFU for standard infrarenal EVAR; or b) the arterial morphology is suitable for a licensed iliac branch device; or c) the internal iliac artery is occluded and the stent limb can be landed in the external iliac artery without embolization of the internal iliac artery.\n\nThere will be no patient excluded as a result of geographical location, disability, gender, marriage and civil partnership status, ethnicity, religion or belief, sexual orientation, socioeconomic status or access to health or social care.","FEMALE","50 Years",{"count":65,"type":66},1112,"ESTIMATED","INTERVENTIONAL",[69],"NA","Elective Abdominal Aortic Aneurysm (AAA) repair is offered when the risk of rupture exceeds the risk of surgery. Women (versus men) have a four-fold higher risk of AAA rupture but almost double the operative mortality. It is unknown whether the current 5.5cm diameter AAA repair threshold, derived from randomised trials including only 4% women, is applicable to women.\n\nTherefore, should women have their aneurysms repaired electively at smaller diameters than men to improve their AAA-related survival and quality of life? WARRIORS is an international randomised controlled trial of early elective endovascular repair versus routine surveillance in women (n=1112) with small asymptomatic AAA (4-5.4cm diameter), nested within a registry of non-participants. The surveillance group will be offered repair for rupture or upon reaching the 5.5cm threshold. Randomisation will be 1:1 stratified by country, age, and aneurysm diameter. The trial is powered for aneurysm-related mortality or rupture at 5 years. Quality-Adjusted-Life-Years is a major secondary outcome. Other outcomes include: operative mortality and complications, anxiety, major cardiovascular adverse events, and cost-effectiveness. Quality-of-life and anxiety questionnaires and \"standard-of-care\" using routine data will be collected.\n\nThe trial aims to progress health equity through provision of evidence for sex-specific clinical guidelines for AAA repair.",[72],"Abdominal Aortic Aneurysm",[74,75,76,77],"abdominal aortic aneurysm","women's health","intervention threshold","endovascular aneurysm repair","NOT_YET_RECRUITING","2025-03-17",{"date":81,"type":82},"2025-03-20","ACTUAL",{"date":84,"type":66},"2025-07-01",{"date":86,"type":66},"2034-04-30",{"name":5,"class":6}]