Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke (CASES) study protocol for a multicenter randomized clinical trial.

IF 5.8 3区医学 Q1 CLINICAL NEUROLOGY European Stroke Journal Pub Date : 2025-02-16 DOI:10.1177/23969873251319941

Louise Maes, Theodora Van Elk, Anne van der Meij, Femke Roelofs, Kris Bogaerts, Reinoud Ph Bokkers, Gert J de Borst, Heleen M den Hertog, Diederik Wj Dippel, Olivier François, Noémie Ligot, Hester F Lingsma, Charles Blm Majoie, Jo Pp Peluso, Illario Tancredi, Ido R van den Wijngaard, Aad van der Lugt, Laetitia Yperzeele, Clark J Zeebregts, Paul J Nederkoorn, Robin Lemmens, Maarten Uyttenboogaart

{"title":"Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke (CASES) study protocol for a multicenter randomized clinical trial.","authors":"Louise Maes, Theodora Van Elk, Anne van der Meij, Femke Roelofs, Kris Bogaerts, Reinoud Ph Bokkers, Gert J de Borst, Heleen M den Hertog, Diederik Wj Dippel, Olivier François, Noémie Ligot, Hester F Lingsma, Charles Blm Majoie, Jo Pp Peluso, Illario Tancredi, Ido R van den Wijngaard, Aad van der Lugt, Laetitia Yperzeele, Clark J Zeebregts, Paul J Nederkoorn, Robin Lemmens, Maarten Uyttenboogaart","doi":"10.1177/23969873251319941","DOIUrl":null,"url":null,"abstract":"Background: The optimal acute management of patients with acute ischemic stroke and a tandem lesion, defined as intracranial large vessel occlusion (LVO) with concomitant carotid artery stenosis or occlusion, remains unclear. Our aim is to assess the efficacy and safety of immediate carotid artery stenting (CAS) compared to delayed management in patients undergoing endovascular treatment (EVT) for acute ischemic stroke due to tandem lesions.Study design: CASES is a phase 3 multicenter prospective randomized open-label blinded endpoint (PROBE) non-inferiority clinical trial. Patients with a computed tomography angiography proven intracranial LVO in the anterior circulation and ipsilateral proximal carotid artery stenosis (⩾50%) or occlusion of presumed atherosclerotic origin will be randomized to either immediate CAS during EVT or to EVT followed by a deferred strategy, which may include carotid endarterectomy (CEA), CAS, or medical management. CASES will be conducted in 27 EVT centers in Belgium and the Netherlands. A total of 600 patients will be included.Study outcomes: The primary outcome is the score on the modified Rankin Scale (mRS) at 90 days. Secondary outcomes include excellent (mRS 0-1) and good (mRS 0-2) functional outcome at 90 days, stroke severity measured with the National Institutes of Health Stroke Scale (NIHSS) at 24 h and 5-7 days, recanalization, infarct volume at 24 h, ischemic stroke recurrence, carotid artery re-occlusion, symptomatic intracranial hemorrhage, and mortality.Summary: This study will provide high-quality randomized data on the efficacy and safety of immediate CAS in patients undergoing EVT for acute ischemic stroke due to a tandem lesion.Trial registration: ClinicalTrials.gov NCT06511089; ISRCTN 14956654.","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":" ","pages":"23969873251319941"},"PeriodicalIF":5.8000,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11831615/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Stroke Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/23969873251319941","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background: The optimal acute management of patients with acute ischemic stroke and a tandem lesion, defined as intracranial large vessel occlusion (LVO) with concomitant carotid artery stenosis or occlusion, remains unclear. Our aim is to assess the efficacy and safety of immediate carotid artery stenting (CAS) compared to delayed management in patients undergoing endovascular treatment (EVT) for acute ischemic stroke due to tandem lesions.

Study design: CASES is a phase 3 multicenter prospective randomized open-label blinded endpoint (PROBE) non-inferiority clinical trial. Patients with a computed tomography angiography proven intracranial LVO in the anterior circulation and ipsilateral proximal carotid artery stenosis (⩾50%) or occlusion of presumed atherosclerotic origin will be randomized to either immediate CAS during EVT or to EVT followed by a deferred strategy, which may include carotid endarterectomy (CEA), CAS, or medical management. CASES will be conducted in 27 EVT centers in Belgium and the Netherlands. A total of 600 patients will be included.

Study outcomes: The primary outcome is the score on the modified Rankin Scale (mRS) at 90 days. Secondary outcomes include excellent (mRS 0-1) and good (mRS 0-2) functional outcome at 90 days, stroke severity measured with the National Institutes of Health Stroke Scale (NIHSS) at 24 h and 5-7 days, recanalization, infarct volume at 24 h, ischemic stroke recurrence, carotid artery re-occlusion, symptomatic intracranial hemorrhage, and mortality.

Summary: This study will provide high-quality randomized data on the efficacy and safety of immediate CAS in patients undergoing EVT for acute ischemic stroke due to a tandem lesion.

Trial registration: ClinicalTrials.gov NCT06511089; ISRCTN 14956654.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

求助全文

约1分钟内获得全文去求助

来源期刊

European Stroke Journal Multiple-

CiteScore

7.50

自引率

6.60%

发文量

102

期刊介绍： Launched in 2016 the European Stroke Journal (ESJ) is the official journal of the European Stroke Organisation (ESO), a professional non-profit organization with over 1,400 individual members, and affiliations to numerous related national and international societies. ESJ covers clinical stroke research from all fields, including clinical trials, epidemiology, primary and secondary prevention, diagnosis, acute and post-acute management, guidelines, translation of experimental findings into clinical practice, rehabilitation, organisation of stroke care, and societal impact. It is open to authors from all relevant medical and health professions. Article types include review articles, original research, protocols, guidelines, editorials and letters to the Editor. Through ESJ, authors and researchers have gained a new platform for the rapid and professional publication of peer reviewed scientific material of the highest standards; publication in ESJ is highly competitive. The journal and its editorial team has developed excellent cooperation with sister organisations such as the World Stroke Organisation and the International Journal of Stroke, and the American Heart Organization/American Stroke Association and the journal Stroke. ESJ is fully peer-reviewed and is a member of the Committee on Publication Ethics (COPE). Issues are published 4 times a year (March, June, September and December) and articles are published OnlineFirst prior to issue publication.