[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100357638":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":40,"responsibleParty":116,"collaborators":25,"id":118,"slug":25,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":25,"enrollmentInfo":126,"targetDuration":25,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":139,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard conventional treatment (surgical or endovascular)","ACTIVE_COMPARATOR","Treatment may include the most appropriate amongst surgical clipping, simple coiling, high-porosity stenting with or without coiling, and intra-arterial flow diversion with or without coiling, which will be predetermined by the treating physician prior to randomization.",[13],"Procedure: surgical clipping, simple coiling, high-porosity stenting with\u002F without coiling, intra-arterial flow diversion with\u002F without coiling",{"label":15,"type":16,"description":17,"interventionNames":18},"WEB embolization device","EXPERIMENTAL","Endovascular treatment with WEB, including standard management of thrombo-embolic risk",[19],"Device: WEB embolization device",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"PROCEDURE","surgical clipping, simple coiling, high-porosity stenting with\u002F without coiling, intra-arterial flow diversion with\u002F without coiling",[9],null,{"type":27,"name":15,"description":15,"armGroupLabels":28,"otherNames":25},"DEVICE",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"daniela E Iancu, MD","CONTACT","514-890-8450","daniela.iancu.med@ssss.gouv.qc.ca",{"name":36,"role":32,"phone":37,"phoneExt":38,"email":39},"Guylaine Gevry, BSc","514-890-8000","27235","guylaine.gevry.chum@ssss.gouv.qc.ca",[41,59,76,93],{"facility":42,"status":43,"city":44,"state":45,"zip":25,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of Alberta Hospital","RECRUITING","Edmonton","Alberta","Canada",{"type":48,"coordinates":49},"Point",[50,51],-113.46871,53.55014,{"lat":51,"lon":50},[54,57],{"name":55,"role":32,"phone":25,"phoneExt":25,"email":56},"Tim E Darsaut, MD","tdarsaut@ualberta.ca",{"name":55,"role":58,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":60,"status":43,"city":61,"state":62,"zip":63,"country":46,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"University of Manitoba Hospital","Winnipeg","Manitoba","R3E 3P5",{"type":48,"coordinates":65},[66,67],-97.14704,49.8844,{"lat":67,"lon":66},[70,74],{"name":71,"role":32,"phone":72,"phoneExt":25,"email":73},"Susan Alcock, RN, MN","204-789-3996","susan.alcock@umanitoba.ca",{"name":75,"role":58,"phone":25,"phoneExt":25,"email":25},"Jai Jay Shiva Shankar, MD",{"facility":77,"status":43,"city":78,"state":79,"zip":25,"country":46,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Hamilton Health Sciences - McMaster University","Hamilton","Ontario",{"type":48,"coordinates":81},[82,83],-79.84963,43.25011,{"lat":83,"lon":82},[86,91],{"name":87,"role":32,"phone":88,"phoneExt":89,"email":90},"Amanda Martyniuk, MSc","(905) 521-2100","44155","martynia@mcmaster.ca",{"name":92,"role":58,"phone":25,"phoneExt":25,"email":25},"Brian van Adel, MD",{"facility":94,"status":43,"city":95,"state":96,"zip":97,"country":46,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Centre Hospitalier de l'Université de Montréal","Montreal","Quebec","H2X 0C1",{"type":48,"coordinates":99},[100,101],-73.58781,45.50884,{"lat":101,"lon":100},[104,105,109,111,114],{"name":36,"role":32,"phone":37,"phoneExt":38,"email":39},{"name":106,"role":32,"phone":37,"phoneExt":107,"email":108},"Ruby Klink, PhD","26359","Ruby.Klink@crchum.qc.ca",{"name":110,"role":58,"phone":25,"phoneExt":25,"email":25},"Daniel Roy, MD",{"name":112,"role":113,"phone":25,"phoneExt":25,"email":25},"Alain Weill, MD","SUB_INVESTIGATOR",{"name":115,"role":113,"phone":25,"phoneExt":25,"email":25},"Daniela Iancu, MD",{"type":117,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100357638",false,"NCT03936647","The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices","RISE","Inclusion Criteria:\n\n* patient with an intracranial aneurysm in whom WEB is considered an appropriate therapeutic option by the participating clinician\n* aneurysm of maximum diameter of 4-11 mm\n* may include (but are not restricted to) saccular bifurcation aneurysms of the middle cerebral artery, basilar bifurcation, carotid terminus, or anterior communicating artery aneurysms\n* Recurring, persistent aneurysm after previous treatment can be included so long as the treating physician judges the aneurysm morphology to be appropriate.\n* Ruptured aneurysms with WFNS ≤ 3\n\nExclusion Criteria:\n\n* Absolute contraindication to surgery, endovascular treatment or anesthesia\n* Patients unable to give informed consent\n* diameter of the aneurysm ≤ 4 mm but ≥ 11 mm\n* Ruptured aneurysms with WFNS 4 or 5","ALL","18 Years",{"count":127,"type":128},250,"ESTIMATED","INTERVENTIONAL",[131],"NA","Intracranial bifurcation aneurysms are commonly repaired with surgical and with endovascular techniques. Wide-necked bifurcation aneurysms (WNBA) are a difficult subset of aneurysms to successfully repair endovascularly, and a number of treatment adjuncts have been designed. One particularly promising innovation is the WEB (Woven EndoBridge), which permits placement of an intra-saccular flow diverting mesh across the aneurysm neck, but which does not require anti-platelet agent therapy. Currently, which treatment option leads to the best outcome for patients with WNBA remains unknown. There is a need to offer treatment with the WEB within the context of a randomized care trial, to patients currently presenting with aneurysms thought to be suitable for the WEB.",[134,135,136,137,138],"Intracranial Aneurysm","Brain Aneurysm","Unruptured Cerebral Aneurysm","Ruptured Cerebral Aneurysm","Cerebral Aneurysm",[140,141,142,143,144,15,145],"intracranial aneurysm","cerebral aneurysm","brain aneurysm","unruptured cerebral aneurysm","ruptured cerebral aneurysm","embolization","2024-08-13",{"date":148,"type":149},"2024-08-15","ACTUAL",{"date":151,"type":149},"2019-07-18",{"date":153,"type":128},"2026-01",{"name":5,"class":6},4]