颅内动脉粥样硬化相关急诊大血管闭塞性卒中机械取栓成功后的血管成形术和/或支架植入术(ASSET):多中心随机试验方案。

IF 2.6 1区 医学 Journal of Investigative Medicine Pub Date : 2024-09-28 DOI:10.1136/svn-2024-003435
Geng Liao, Hongyu Qiao, Chengbo Dai, Weiwen Yi, Liang Zhang, Zai Liang, Li Li, Yuemei He, Zhenyu Zhang, Zhong Ji, Li'an Huang
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引用次数: 0

摘要

理由:在临床实践中,颅内动脉粥样硬化性狭窄相关的新生大血管闭塞(ICAS-LVO)卒中患者机械取栓术后残余狭窄的处理仍是一个不明确的问题。目的:论证一项临床试验的设计,即对成功再通的ICAS-LVO卒中患者残余狭窄进行急诊球囊血管成形术和/或支架术(BAS)联合标准药物治疗(SMT):ASSET是一项由研究人员设计的多中心、前瞻性、随机、开放标签、终点盲法对照临床试验(PROBE)。该试验评估了在ICAS-LVO卒中患者中,急诊BAS联合SMT与单独SMT相比的有效性和安全性:随机分组后 90 (±7) 天评估的主要结果是责任血管缺血性中风的发生率。24(±3)小时内有症状的颅内出血是主要的安全性结果:ASSET试验旨在为ICAS-LVO脑卒中患者成功再通后采用急诊BAS治疗残余狭窄的有效性和安全性提供有力证据:试验注册号:ChiCTR2300079069。
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Angioplasty and/or stenting following successful mechanical thrombectomy for intracranial atherosclerosis-related emergent large vessel occlusive stroke (ASSET): protocol of a multicentre randomised trial.

Rationale: The management of residual stenosis after mechanical thrombectomy in patients with intracranial atherosclerotic stenosis-related emerge large vessel occlusive (ICAS-LVO) stroke is still unclear question in clinical practice.

Aim: To demonstrate the design of a clinical trial on emergency balloon angioplasty and/or stenting (BAS) combined with standard medical treatment (SMT) for residual stenosis of ICAS-LVO stroke patients with successful recanalisation.

Design: ASSET is a multicentre, prospective, randomised, open-label, blinded end-point, controlled clinical trial designed (PROBE) by investigators. This trial evaluates the effectiveness and the safety of emergency BAS in combination with SMT compared with SMT alone in ICAS-LVO stroke patients with successful recanalisation (defined as expanded treatment in cerebral ischaemia grade of 2b50-3 and maintained for more than 20 min) and residual stenosis (defined as ≥50%) up to 24 hours after the onset of symptoms or the last known well.

Outcome: The primary outcome assessed at 90 (±7) days after randomisation is the incidence of ischaemic stroke in the responsible vessel. Symptomatic intracranial haemorrhage within 24 (±3) hours is the primary safety outcome.

Discussion: The ASSET trial is designed to provide strong evidence on the effectiveness and safety of emergency BAS to treat residual stenosis after successful recanalisation in patients with ICAS-LVO stroke.

Trial registration number: ChiCTR2300079069.

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来源期刊
Journal of Investigative Medicine
Journal of Investigative Medicine MEDICINE, GENERAL & INTERNALMEDICINE, RESE-MEDICINE, RESEARCH & EXPERIMENTAL
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111
期刊介绍: Journal of Investigative Medicine (JIM) is the official publication of the American Federation for Medical Research. The journal is peer-reviewed and publishes high-quality original articles and reviews in the areas of basic, clinical, and translational medical research. JIM publishes on all topics and specialty areas that are critical to the conduct of the entire spectrum of biomedical research: from the translation of clinical observations at the bedside, to basic and animal research to clinical research and the implementation of innovative medical care.
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