[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100382580":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":67,"collaborators":69,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":19,"enrollmentInfo":104,"targetDuration":19,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":50,"whyStopped":19,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Acute Stenting","ACTIVE_COMPARATOR","All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be revascularized with a stent during the acute thrombectomy procedure.",[13,14],"Device: Carotid artery stenting","Drug: Antiplatelet Agents",{"label":16,"type":17,"description":18,"interventionNames":19},"No Acute Stenting","NO_INTERVENTION","All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be not revascularized with a stent during the acute thrombectomy procedure.",null,[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Carotid artery stenting","The type of stent should be one commonly used for ICA stenting. Balloon angioplasty before and\u002For after stent placement will be allowed as required. Stenting should be performed after intracranial thrombectomy unless specific technical circumstances suggest that access to the intracranial circulation requires anterograde stenting. Embolic protection devices should not be used routinely during ICA stent placement.",[9],[27],"Stenting",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":19},"DRUG","Antiplatelet Agents","The following antiplatelet regimen should be used: For patients having received IV thrombolysis, immediate post-procedural oral or intrarectal single antiplatelet agents, (Aspirin 325mg PO or 650mg PR). A second agent (usually Clopidogrel 300mg PO) is added after follow-up brain imaging at 12-24 hours confirms absence of significant ICH. For patients having not been treated with IV thrombolysis, dual antiplatelet therapy (Aspirin 325mg PO or 650mg PR and Clopidogrel 300-600mg PO) is given immediately post-procedure. Routine use of GPIIb\u002FIIIa inhibitors, periprocedural IV Heparin is discouraged.",[9],[34],{"name":35,"affiliation":5,"role":36},"Alexandre Y Poppe, MD CM","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","5148908000","26260","alexandre.poppe.med@ssss.gouv.qc.ca",{"name":44,"role":39,"phone":40,"phoneExt":45,"email":46},"Nandy Simon, BSc","26242","nandy-shelwine.simon.chum@ssss.gouv.qc.ca",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Centre Hospitalier de l'Université de Montréal","RECRUITING","Montreal","Quebec","H2X 0C1","Canada","CA",{"type":57,"coordinates":58},"Point",[59,60],-73.58781,45.50884,{"lat":60,"lon":59},[63,65],{"name":35,"role":39,"phone":40,"phoneExt":64,"email":42},"26268",{"name":44,"role":39,"phone":40,"phoneExt":66,"email":46},"262642",{"type":68,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[70,72,74,76,78,80,82,84,86,88,90,92],{"name":71,"class":6},"McGill University",{"name":73,"class":6},"Laval University",{"name":75,"class":6},"Queen's University",{"name":77,"class":6},"University of Ottawa",{"name":79,"class":6},"McMaster University",{"name":81,"class":6},"University of Calgary",{"name":83,"class":6},"University of British Columbia",{"name":85,"class":6},"Dalhousie University",{"name":87,"class":6},"Health Sciences North Research Institute",{"name":89,"class":6},"University of Toronto",{"name":91,"class":6},"University of Alberta",{"name":93,"class":6},"Canadian Stroke Consortium (CSC)","100382580","endovascular-acute-stroke-intervention---tandem-occlusion-trial-100382580",false,"NCT04261478","Endovascular Acute Stroke Intervention - Tandem OCclusion Trial","A Multi-centre, Prospective, Randomized, Open-label, Blinded Endpoint (PROBE) Controlled Trial Comparing Cervical Internal Carotid Artery Stenting to no Stenting During Thrombectomy for Tandem Occlusion Stroke","EASI-TOC","Inclusion Criteria:\n\n* Acute ischemic anterior circulation stroke eligible for endovascular therapy according to local guidelines, with or without prior intravenous thrombolysis:\n\n  * Occlusion of the carotid terminus, M1 or M2 segments of the middle cerebral artery (MCA)\n  * A neurological deficit judged to be disabling by the patient and\u002For treating physician\n  * Any acute imaging judged by the treating physician to demonstrate salvageable brain tissue possibly amenable to EVT\n  * Groin puncture within 24-hours of onset or last known normal\n* Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion of presumed atherosclerotic etiology on initial non-invasive vascular imaging\n* Informed consent from patient or surrogate or deferral of consent, according to local ethics policies\n\nExclusion Criteria:\n\n* Pre-existing neurological impairment (modified Rankin score ≥3)\n* Any underlying disease or condition making protocol adherence and\u002For 3-month follow-up unlikely\n* Any known contra-indication to EVT, angioplasty\u002Fstenting, or antiplatelet therapy\n* Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion NOT confirmed on conventional angiography\n* Ipsilateral ICA stenosis or occlusion attributable to clinically or radiologically confirmed arterial dissection\n* Isolated cervical carotid occlusion without intracranial occlusion\n* Pregnancy","ALL","18 Years",{"count":105,"type":106},458,"ESTIMATED","INTERVENTIONAL",[109],"NA","Patients with tandem occlusion or tandem lesion (TL), that is, stroke with an acute intracranial anterior circulation occlusion and an ipsilateral cervical ICA (c-ICA) high-grade stenosis or occlusion, constitute about 15-20% of patients undergoing endovascular thrombectomy (EVT).\n\nHowever, the optimal treatment of acute stroke patients with TL remains uncertain, as relatively few patients with TL were included in the major randomized controlled trials of EVT and management of the c-ICA was generally not specified by protocol nor analyzed post-hoc.\n\nRecent large multi-centre retrospective cases series suggest that acutely stented patients may have more favorable outcomes than patients treated with angioplasty alone or those with no acute ICA intervention, but high quality randomized trial data are lacking.\n\nEASI-TOC, a phase 3, academic multi-centre, controlled trial (PROBE design) with embedded pilot phase, will seek to determine if in patients undergoing acute intracranial thrombectomy for anterior circulation stroke with concurrent ipsilateral symptomatic high-grade (≥70%) atherosclerotic stenosis or occlusion of the extracranial ICA, endovascular ICA revascularization with stenting is superior to intracranial thrombectomy alone with regards to functional outcome at 90 days. Patients will be randomized to Acute stenting or No acute stenting (1:1 allocation).",[112,113,114],"Stroke, Acute","Carotid Stenosis","Carotid Artery Diseases",[116,117,118],"Thrombectomy","Tandem occlusion","Carotid stenting","2023-11-14",{"date":121,"type":122},"2023-11-18","ACTUAL",{"date":124,"type":122},"2020-08-31",{"date":126,"type":106},"2027-03",{"name":5,"class":6},1]