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

IF 4.5 3区医学 Q1 CLINICAL NEUROLOGY European Stroke Journal Pub Date : 2025-09-01 Epub 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

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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.

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颈动脉支架植入术在血管内治疗急性缺血性卒中（病例）研究方案多中心随机临床试验。

背景：急性缺血性卒中合并串联病变（定义为颅内大血管闭塞（LVO）伴颈动脉狭窄或闭塞）患者的最佳急性处理尚不清楚。我们的目的是评估即时颈动脉支架植入术（CAS）与延迟治疗在急性缺血性脑卒中患者血管内治疗（EVT）的有效性和安全性。研究设计：CASES是一项3期多中心前瞻性随机开放标签盲法终点（PROBE）非劣效性临床试验。经计算机断层血管造影证实在前循环中颅内LVO和同侧颈动脉近端狭窄（大于或等于50%）或假定的动脉粥样硬化起源闭塞的患者将被随机分配到EVT期间的立即CAS或EVT之后的延迟策略，其中可能包括颈动脉内膜切除术（CEA）， CAS或医疗管理。病例将在比利时和荷兰的27个EVT中心进行。总共将包括600名患者。研究结果：主要结果为90天的改良Rankin量表（mRS）评分。次要结局包括90天的功能结局为优秀（mRS 0-1）和良好（mRS 0-2）， 24小时和5-7天用美国国立卫生研究院卒中量表（NIHSS）测量卒中严重程度，24小时再通，梗死体积，缺血性卒中复发，颈动脉再闭塞，症状性颅内出血和死亡率。摘要：本研究将提供高质量的随机数据，以证明急性缺血性脑卒中并发病变患者行EVT时即刻CAS的有效性和安全性。试验注册：ClinicalTrials.gov NCT06511089；ISRCTN 14956654。

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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.