GNR-004

YOKNEAM, Israel & SOUTHLAKE, Texas & MARSEILLE, France--( BUSINESS WIRE )-- Rapid Medical ™ , a leading developer of advanced endovascular devices, announces completion of the interim safety analysis of the DISTALS Study at the 2024 Congress of the European Society of Minimally Invasive Neurological Therapy (ESMINT) Congress. “We are pleased that the DSMB found that the safety profile of TIGERTRIEVER 13 allows us to continue randomization. This reflects its unique design which facilitates thrombectomy procedures in smaller vessels given its low profile and adjustability,” comments Dr. David Fiorella of Stony Brook University Medical Center in Stony Brook, NY, and Principal Study Investigator. Per protocol, all safety data, including the rate of symptomatic intracerebral hemorrhage (sICH), was analyzed for 82 patients by the Data Safety and Monitoring Board (DSMB), which includes Drs. Josh Hirsch, MD, Thabele (Bay) Leslie-Mazwi MD, Robert W. Regenhardt MD, PhD, and Scott Hamilton, PhD. The data was adjudicated by the imaging core lab and the Clinical Event Committee (CEC). TIGERTRIEVER™ 13 ’s adjustability engages the clot and then relaxes to minimize vessel traction upon removal. Published data indicates distal stroke treatment performed with TIGERTRIEVER 13 can lead to higher revascularization success and post-treatment patient outcomes, with 78% recanalization success vs. 42% with Medical Management. 1,2,3,4 “With safety at the core of the DISTALS Study, the interim data is very reassuring,” said Dr. Walid Haddad , Chief Clinical Officer at Rapid Medical. “We are thrilled to partner with a rigorous team of physicians to expand thrombectomy to under-treated areas of the brain like medium vessel stroke.” About Rapid Medical Rapid Medical expands what’s possible in neurovascular treatment by pioneering advanced interventional devices that treat ischemic and hemorrhagic stroke. Utilizing proprietary manufacturing techniques, Rapid Medical’s products are remotely adjustable and fully visible. This enables physicians to respond in real-time to the anatomy and tailor the approach to every patient for better procedural outcomes. TIGERTRIEVER™ 13 , 17 and 21 , COMANECI ™ and COLUMBUS™/DRIVEWIRE are CE marked and FDA cleared. TIGERTRIEVER XL is also CE marked. More information is available at www.rapid-medical.com ------ REFERENCES: Ospel JM, Menon BK, Demchuk AM, et al. Clinical Course of Acute Ischemic Stroke Due to Medium Vessel Occlusion With and Without Intravenous Alteplase Treatment. Stroke. 2020;51(11):3232-3240. doi:10.1161/STROKEAHA.120.030227 Rikhtegar R, Mosimann PJ, Weber R, et al. Effectiveness of very low profile thrombectomy device in primary distal medium vessel occlusion, as rescue therapy after incomplete proximal recanalization or following iatrogenic thromboembolic events. J Neurointerv Surg. 2021;13(12):1067-1072. doi:10.1136/neurintsurg-2020-017035 Fischer S, Will L, Phung T, Weber W, Maus V, Nordmeyer H. The Tigertriever 13 for mechanical thrombectomy in distal and medium intracranial vessel occlusions. Neuroradiology. 2022;64(4):775-783. doi:10.1007/s00234-021-02792-x Guenego A, Mine B, Bonnet T, et al. Thrombectomy for distal medium vessel occlusion with a new generation of Stentretriever (Tigertriever 13) [published online ahead of print, 2021 Sep 13]. Interv Neuroradiol. 2021;15910199211039926. doi:10.1177/15910199211039926

2024年6月15日，医学顶刊《新英格兰医学杂志》（NEJM）发表了两篇来自首都医科大学附属北京天坛医院王拥军教授团队进行的随机对照、3期临床试验——RAISE和TRACE-Ⅲ，两项研究均关注缺血性卒中非取栓患者溶栓治疗，结果同期公布于6月14日开幕的中国卒中学会第十届学术年会暨天坛脑血管病会议。 第一篇论文题为：Reteplase versus Alteplase for Acute Ischemic Stroke（RAISE）。  RAISE 研究是一项确证性Ⅲ期临床试验，评估瑞替普酶与阿替普酶在 4.5 小时内发病 AIS 患者中的有效性和安全性。作为一项注册临床试验，该研究共纳入 1412 例患者。研究结果显示，在 4.5 小时内发病的 AIS 患者主要疗效方面，瑞替普酶不劣于阿替普酶。进一步的优效性检验显示，瑞替普酶的疗效优于阿替普酶。 现在在临床应用和指南推荐里，缺血性卒中静脉溶栓药物只有阿替普酶和替奈普酶，RAISE研究为瑞替普酶在缺血性卒中患者治疗提供了高质量循证医学证据，有望改写指南，并为临床医师及患者溶栓药物提供经济、便捷的多样化选择。    “下一步，我们要开展瑞替普酶的国际多中心试验，让这种‘北京制造’的药物尽快‘出海’。”王拥军说。    第二篇论文题为：Tenecteplase for Ischemic Stroke at 4.5 to 24 Hours without Thrombectomy（TRACE-Ⅲ）。 替奈普酶（Tenecteplase）是一种是组织型纤溶酶原激活剂（t-PA）的多点变异体，是第三代纤溶剂，适用于卒中发作后4.5小时内接受治疗的符合条件的患者。然而，替奈普酶在超过4.5小时的有效性的数据有限。 在这项名为TRACE-Ⅲ的随机对照、3期临床试验中，研究团队将经灌注成像确定有可挽救的脑组织且无法接受介入取栓治疗的大血管闭塞性脑卒中或颈内动脉闭塞患者随机分配至两组，一组接受替奈普酶治疗，另一组接受标准医疗治疗，治疗时间在患者最后一次被认为健康后的4.5-24小时内。 研究团队得出结论，在这项针对大血管闭塞性缺血性卒中的中国患者的临床试验中，大多数患者未接受血管内取栓治疗。与标准药物治疗相比，在卒中发作后4.5-24小时内给予替奈普酶治疗，可减少残疾并改善生存情况，但有症状的颅内出血的发生率似乎较高。 “这是世界上第一次证实静脉溶栓时间窗拓宽到24小时内安全有效。”项目执行负责人、北京天坛医院神经病学中心血管神经病学科副主任熊云云介绍，在全球卒中患者中，发病24小时内且存在可挽救脑组织，但因各种原因无法接受血管内治疗的大动脉闭塞患者占很大比例，“TRACE Ⅲ”试验为此类患者提供了晚时间窗静脉溶栓治疗新方案。同时，替奈普酶静脉注射的便捷的给药方式，有望降低院间转运过程中卒中进展风险。    《健康中国行动——心脑血管疾病防治行动实施方案（2023-2030年）》提到，到2030年，国内所有二级及以上可收治脑血管病的医疗机构全部开展静脉溶栓治疗，中国缺血性卒中患者静脉溶栓比例提升至80%。王拥军表示，按目前中国缺血性卒中发病数量计算，实现这一目标后预计每年可减少约43.5万人因卒中致残。 撰文 | Anna.AN 编辑 | Swagpp ● 大教训！“女大学生怀孕7月被当肾病医治后身亡”影响深远！隐瞒怀孕并乱说末次月经，面对如此患者，如何防止被带偏？医生要有警觉意识 ● 热议！40岁的老主治，我还能跳槽吗？主任：年轻时多学习，不要想着待遇！医生反驳：人已到中年，再不挣钱家庭就完了 ● 震撼！绩效工资成了负数，真要倒贴上班啦？医生求助：要不要逃离这样的医院？医生们自己挣的钱却只能分10% ，真的太少啦！ 版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。 点击下方「阅读原文」 立刻下载梅斯医学APP！