[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100357638":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":40,"responsibleParty":117,"collaborators":25,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":121,"sex":126,"minAge":127,"maxAge":25,"enrollmentInfo":128,"targetDuration":25,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":141,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"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",[41,60,77,94],{"facility":42,"status":43,"city":44,"state":45,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Alberta Hospital","RECRUITING","Edmonton","Alberta","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-113.46871,53.55014,{"lat":52,"lon":51},[55,58],{"name":56,"role":32,"phone":25,"phoneExt":25,"email":57},"Tim E Darsaut, MD","tdarsaut@ualberta.ca",{"name":56,"role":59,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":61,"status":43,"city":62,"state":63,"zip":64,"country":46,"countryCode":47,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"University of Manitoba Hospital","Winnipeg","Manitoba","R3E 3P5",{"type":49,"coordinates":66},[67,68],-97.14704,49.8844,{"lat":68,"lon":67},[71,75],{"name":72,"role":32,"phone":73,"phoneExt":25,"email":74},"Susan Alcock, RN, MN","204-789-3996","susan.alcock@umanitoba.ca",{"name":76,"role":59,"phone":25,"phoneExt":25,"email":25},"Jai Jay Shiva Shankar, MD",{"facility":78,"status":43,"city":79,"state":80,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Hamilton Health Sciences - McMaster University","Hamilton","Ontario",{"type":49,"coordinates":82},[83,84],-79.84963,43.25011,{"lat":84,"lon":83},[87,92],{"name":88,"role":32,"phone":89,"phoneExt":90,"email":91},"Amanda Martyniuk, MSc","(905) 521-2100","44155","martynia@mcmaster.ca",{"name":93,"role":59,"phone":25,"phoneExt":25,"email":25},"Brian van Adel, MD",{"facility":95,"status":43,"city":96,"state":97,"zip":98,"country":46,"countryCode":47,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Centre Hospitalier de l'Université de Montréal","Montreal","Quebec","H2X 0C1",{"type":49,"coordinates":100},[101,102],-73.58781,45.50884,{"lat":102,"lon":101},[105,106,110,112,115],{"name":36,"role":32,"phone":37,"phoneExt":38,"email":39},{"name":107,"role":32,"phone":37,"phoneExt":108,"email":109},"Ruby Klink, PhD","26359","Ruby.Klink@crchum.qc.ca",{"name":111,"role":59,"phone":25,"phoneExt":25,"email":25},"Daniel Roy, MD",{"name":113,"role":114,"phone":25,"phoneExt":25,"email":25},"Alain Weill, MD","SUB_INVESTIGATOR",{"name":116,"role":114,"phone":25,"phoneExt":25,"email":25},"Daniela Iancu, MD",{"type":118,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100357638","the-rise-trial-a-randomized-trial-on-intra-saccular-endobridge-devices-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":129,"type":130},250,"ESTIMATED","INTERVENTIONAL",[133],"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.",[136,137,138,139,140],"Intracranial Aneurysm","Brain Aneurysm","Unruptured Cerebral Aneurysm","Ruptured Cerebral Aneurysm","Cerebral Aneurysm",[142,143,144,145,146,15,147],"intracranial aneurysm","cerebral aneurysm","brain aneurysm","unruptured cerebral aneurysm","ruptured cerebral aneurysm","embolization","2024-08-13",{"date":150,"type":151},"2024-08-15","ACTUAL",{"date":153,"type":151},"2019-07-18",{"date":155,"type":130},"2026-01",{"name":5,"class":6},4]