Background Our recent pilot study suggests intra-arterial tenecteplase (TNK) during the first pass of endovascular treatment (EVT) seems safe, may increase first-pass reperfusion and good outcome in acute ischaemic stroke (AIS) patients with large-vessel occlusion (LVO). Aims To determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients presenting up to 24 hours from symptom onset. Sample size estimates A maximum of 380 patients are required to test the superiority hypothesis with 80% power according to a two-side 0.05 level of significance, stratified by age, gender, baseline systolic blood pressure, prestroke modified Rankin Scale (mRS), baseline National Institute of Health stroke scale, baseline ASPECTS, time from onset to groin puncture, intravenous thrombolysis before EVT, stroke territory and stroke aetiology. Design Intra-arterial TNK during thrombectomy for acute stroke (BRETIS-TNK II) study is a prospective, randomised, adaptive enrichment, open-label, blinded end point, multicentre study. Eligible AIS-LVO patients are randomly assigned into the experimental group and control group with a ratio of 1:1. The experimental group will be treated with intra-arterial infusion of TNK during EVT. The control group will be treated with standard EVT. Outcome The primary end point is a favourable outcome, defined as an mRS score of 0–2 at 90 days. The primary safety end point is symptomatic intracranial haemorrhage within 48 hours, which is defined as an increase in the National Institutes of Health Stroke Scale score of ≥4 points as a result of the intracranial haemorrhage. Conclusions The results of BRETIS-TNK II will provide evidence for the efficacy and safety of intra-arterial TNK administration during EVT in AIS patients with LVO. No data are available.

中文翻译：

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急性卒中血栓切除术期间的动脉内替奈普酶 (BRETIS-TNK II)：原理和设计

背景 我们最近的初步研究表明，在首次血管内治疗 (EVT) 期间动脉内注射替奈普酶 (TNK) 似乎是安全的，可能会增加大血管闭塞 (LVO) 急性缺血性卒中 (AIS) 患者的首次再灌注和良好预后）。目的 确定在症状出现后 24 小时内就诊的 AIS-LVO 患者在 EVT 期间动脉内 TNK 给药的有效性和安全性。样本量估计 最多需要 380 名患者根据两侧 0.05 显着性水平以 80% 功效检验优越性假设，按年龄、性别、基线收缩压、卒中前改良 Rankin 量表 (mRS)、基线分层美国国立卫生研究院卒中量表、基线 ASPECTS、从发病到腹股沟穿刺的时间、EVT 前静脉溶栓、卒中范围和卒中病因。设计急性卒中血栓切除术期间的动脉内 TNK (BRETIS-TNK II) 研究是一项前瞻性、随机、适应性富集、开放标签、盲态终点、多中心研究。符合条件的AIS-LVO患者按1:1的比例随机分为实验组和对照组。实验组在EVT期间接受动脉内输注TNK。对照组将接受标准 EVT 治疗。结果 主要终点是良好的结果，定义为 90 天时 mRS 评分为 0-2。主要安全终点是48小时内出现症状性颅内出血，其定义为因颅内出血而导致美国国立卫生研究院卒中量表评分增加≥4分。结论 BRETIS-TNK II 结果将为 AIS 伴 LVO 患者 EVT 期间动脉内 TNK 给药的有效性和安全性提供证据。无可用数据。