[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555361":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":55,"collaborators":57,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":26,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Carotid artery stenting during endovascular thrombectomy","EXPERIMENTAL","In the intervention group, the cervical carotid artery lesion will be treated with a stent during the EVT (just before or directly after intracranial thrombus removal)",[13],"Procedure: carotid artery stenting during EVT",{"label":15,"type":16,"description":17,"interventionNames":18},"No immediate carotid artery stenting during endovascular thrombectomy","ACTIVE_COMPARATOR","The control group will be treated according to the national guidelines with carotid endarterectomy of carotid artery stenting (for patients with non-disabling stroke) or medical management alone (for patients with severe disabling stroke)",[19],"Other: no carotid artery stenting during EVT",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","carotid artery stenting during EVT","Patients with an ipsilateral high grade carotid artery stenosis or occlusion of presumed atherosclerotic origin and an proximal intracranial large vessel occlusion in the anterior circulation will be randomized using a web-based randomization tool to immediate carotid artery stenting or deferred treatment strategy of carotid artery stenosis.\n\nIn the intervention group, the cervical carotid artery lesion will be treated with a stent during the EVT (just before or directly after intracranial thrombus removal), the control group will be treated according to the national guidelines with carotid endarterectomy of carotid artery stenting (for patients with non-disabling stroke) or medical management alone (for patients with severe disabling stroke).",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"no carotid artery stenting during EVT","A deferred treatment approach: carotid revascularization within two weeks after stroke onset or best medical management only, depending on the functional recovery of the patient.",[15],[32],{"name":33,"affiliation":5,"role":34},"Maarten Uyttenboogaart, MD PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+31 50 3612400","m.uyttenboogaart@umcg.nl",[41],{"facility":5,"status":42,"city":43,"state":26,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Groningen","9713 GZ","Netherlands","NL",{"type":48,"coordinates":49},"Point",[50,51],6.56667,53.21917,{"lat":51,"lon":50},[54],{"name":33,"role":37,"phone":26,"phoneExt":26,"email":39},{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[58],{"name":59,"class":6},"Universitaire Ziekenhuizen KU Leuven","100555361","phase-3-carotid-artery-stenting-during-endovascular-treatment-of-acute-stroke-100555361",false,"NCT06511089","Carotid Artery Stenting During Endovascular Treatment of Acute Stroke","Carotid Artery Stenting During Endovascular Treatment of Acute Ischemic Stroke: A Randomized Multicenter Clinical Trial in Patients With Acute Ischemic Stroke and Carotid Artery Stenosis Undergoing Endovascular Treatment","CASES","Inclusion Criteria:\n\n1. Acute ischemic stroke due to proximal intracranial occlusion in the anterior circulation (intracranial ICA, M1, proximal M2) on the CT angiography\n2. Stenosis \\>50% according to the NASCET criteria16 or initial occlusion of the ipsilateral cervical carotid artery of presumed atherosclerotic origin on baseline CT angiography\n3. Eligible for EVT according to the guidelines: EVT within 6 hours of onset or EVT between 6-24 hours after onset based on perfusion CT imaging selection (conform current guidelines)\n4. Baseline National Institute of Health Stroke Scale (NIHSS) score ≥2\n5. Age \\>18 years\n6. Written informed consent (deferred consent)\n\nExclusion Criteria:\n\n1. Any intracranial hemorrhage\n2. Cervical carotid artery stenosis or occlusion with other causes than presumed atherosclerosis (e.g. carotid artery dissection, floating thrombus, carotid web)\n3. Any exclusion criterion for EVT according to the guidelines\n4. Pre stroke disability (defined as a modified Rankin Scale score \\>2)\n5. Recent gastro-intestinal or urinary tract hemorrhage (\\\u003C6 weeks)\n6. Recent severe head trauma (\\\u003C6 weeks)\n7. Recent infarction on baseline brain CT in the same vascular territory (\\\u003C6 weeks)\n8. Known allergy to aspirin and\u002For clopidogrel\n9. Pregnancy","ALL","18 Years",{"count":71,"type":72},600,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","Rationale: Approximately 20% of the patients with acute ischemic stroke due to an intracranial large vessel occlusion (LVO) has a high-grade stenosis in the ipsilateral cervical carotid artery. It is uncertain whether immediate carotid artery stenting (CAS) of a cervical carotid artery stenosis during endovascular thrombectomy (EVT) is beneficial. Immediate CAS could improve cerebral perfusion and prevent recurrent ischemic stroke but could also increase the chance of intracranial hemorrhagic complications due to hyperperfusion syndrome or to the required antiplatelet treatment to prevent stent occlusion. Moreover, some patients end up with a severe disabling stroke after EVT. In these patients carotid revascularization by carotid endarterectomy (CEA) or CAS would usually not be performed but these patients would be treated by medical management only.\n\nObjective: to assess the safety and efficacy of immediate cervical CAS during EVT in patients with acute ischemic stroke due to LVO with a high-grade stenosis \\>50% or occlusion of the ipsilateral cervical carotid artery.\n\nStudy design: prospective randomized open label controlled trial comparing immediate CAS during EVT versus EVT with deferred treatment of the cervical carotid artery lesion (deferred CAS\u002FCEA or medical management alone). Outcome assessment will be blinded for treatment allocation.",[78,79,80,81,82],"Stroke, Acute","Stroke, Ischemic","Carotid Stenosis","Carotid Atherosclerosis","Carotid Occlusion","2024-07-15",{"date":85,"type":86},"2024-07-19","ACTUAL",{"date":88,"type":86},"2022-11-15",{"date":90,"type":72},"2026-11-15",{"name":5,"class":6},1]