{"title":"评估使用 Versi Retriever 进行机械血栓切除术的安全性和有效性的多中心临床试验。","authors":"Nobuyuki Ohara, Hirotoshi Imamura, Tetsu Satow, Hiroshi Yamagami, Shinichi Yoshimura, Nobutaka Horie, Akira Ishii, Toshiyuki Fujinaka, Yasushi Matsumoto, Tomoyuki Tsumoto, Shinya Kohyama, Yuji Matsumaru, Koji Iihara, Naoya Kuwayama, Teruyuki Hirano, Yasushi Ito, Haruko Yamamoto, Yoji Nagai, Chiaki Sakai, Nobuyuki Sakai","doi":"10.1136/jnis-2024-022207","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>This study aimed to elucidate the safety and efficacy of mechanical thrombectomy using the Versi Retriever in patients with acute ischemic stroke (AIS).</p><p><strong>Methods: </strong>This was a prospective, multicenter, single-arm study conducted at 10 institutes in Japan from December 2018 to March 2021 on mechanical thrombectomy using the Versi Retriever in patients with AIS. The primary efficacy outcome was the modified Rankin scale (mRS) 0-2 at 90 days after the procedure. The primary safety outcome was mortality within 90 days after the procedure.</p><p><strong>Results: </strong>Fifty-eight patients with a mean age of 72.7 years were enrolled in the study. The primary efficacy outcome of mRS 0-2 at 90 days was 62.0% (95% CI 47.2-75.3%) in patients within 8 hours of stroke onset. The rate of immediate reperfusion of Thrombolysis in Cerebral Infarction (TICI) grade 2b-3 using the Versi Retriever in three passes was 78.0% (64.0-88.5%). The rate of final reperfusion of TICI 2b-3 was 100% (92.9-100%). The primary safety outcome of mortality within 90 days was 8.0% (2.2-19.2%) in patients within 8 hours of AIS onset. The incidence of intracranial hemorrhage within 24 hours was 12.0% (4.5-24.3%) for symptomatic cases and 32.0% (19.5-46.7%) for asymptomatic cases.</p><p><strong>Conclusion: </strong>The Versi Retriever proved to be a safe and effective option for mechanical thrombectomy in patients with AIS.</p>","PeriodicalId":16411,"journal":{"name":"Journal of NeuroInterventional Surgery","volume":" ","pages":""},"PeriodicalIF":4.5000,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Multicenter clinical trial evaluating the safety and efficacy of mechanical thrombectomy using the Versi Retriever.\",\"authors\":\"Nobuyuki Ohara, Hirotoshi Imamura, Tetsu Satow, Hiroshi Yamagami, Shinichi Yoshimura, Nobutaka Horie, Akira Ishii, Toshiyuki Fujinaka, Yasushi Matsumoto, Tomoyuki Tsumoto, Shinya Kohyama, Yuji Matsumaru, Koji Iihara, Naoya Kuwayama, Teruyuki Hirano, Yasushi Ito, Haruko Yamamoto, Yoji Nagai, Chiaki Sakai, Nobuyuki Sakai\",\"doi\":\"10.1136/jnis-2024-022207\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>This study aimed to elucidate the safety and efficacy of mechanical thrombectomy using the Versi Retriever in patients with acute ischemic stroke (AIS).</p><p><strong>Methods: </strong>This was a prospective, multicenter, single-arm study conducted at 10 institutes in Japan from December 2018 to March 2021 on mechanical thrombectomy using the Versi Retriever in patients with AIS. The primary efficacy outcome was the modified Rankin scale (mRS) 0-2 at 90 days after the procedure. The primary safety outcome was mortality within 90 days after the procedure.</p><p><strong>Results: </strong>Fifty-eight patients with a mean age of 72.7 years were enrolled in the study. The primary efficacy outcome of mRS 0-2 at 90 days was 62.0% (95% CI 47.2-75.3%) in patients within 8 hours of stroke onset. The rate of immediate reperfusion of Thrombolysis in Cerebral Infarction (TICI) grade 2b-3 using the Versi Retriever in three passes was 78.0% (64.0-88.5%). The rate of final reperfusion of TICI 2b-3 was 100% (92.9-100%). The primary safety outcome of mortality within 90 days was 8.0% (2.2-19.2%) in patients within 8 hours of AIS onset. The incidence of intracranial hemorrhage within 24 hours was 12.0% (4.5-24.3%) for symptomatic cases and 32.0% (19.5-46.7%) for asymptomatic cases.</p><p><strong>Conclusion: </strong>The Versi Retriever proved to be a safe and effective option for mechanical thrombectomy in patients with AIS.</p>\",\"PeriodicalId\":16411,\"journal\":{\"name\":\"Journal of NeuroInterventional Surgery\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":4.5000,\"publicationDate\":\"2024-10-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of NeuroInterventional Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/jnis-2024-022207\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"NEUROIMAGING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of NeuroInterventional Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/jnis-2024-022207","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"NEUROIMAGING","Score":null,"Total":0}
Multicenter clinical trial evaluating the safety and efficacy of mechanical thrombectomy using the Versi Retriever.
Background: This study aimed to elucidate the safety and efficacy of mechanical thrombectomy using the Versi Retriever in patients with acute ischemic stroke (AIS).
Methods: This was a prospective, multicenter, single-arm study conducted at 10 institutes in Japan from December 2018 to March 2021 on mechanical thrombectomy using the Versi Retriever in patients with AIS. The primary efficacy outcome was the modified Rankin scale (mRS) 0-2 at 90 days after the procedure. The primary safety outcome was mortality within 90 days after the procedure.
Results: Fifty-eight patients with a mean age of 72.7 years were enrolled in the study. The primary efficacy outcome of mRS 0-2 at 90 days was 62.0% (95% CI 47.2-75.3%) in patients within 8 hours of stroke onset. The rate of immediate reperfusion of Thrombolysis in Cerebral Infarction (TICI) grade 2b-3 using the Versi Retriever in three passes was 78.0% (64.0-88.5%). The rate of final reperfusion of TICI 2b-3 was 100% (92.9-100%). The primary safety outcome of mortality within 90 days was 8.0% (2.2-19.2%) in patients within 8 hours of AIS onset. The incidence of intracranial hemorrhage within 24 hours was 12.0% (4.5-24.3%) for symptomatic cases and 32.0% (19.5-46.7%) for asymptomatic cases.
Conclusion: The Versi Retriever proved to be a safe and effective option for mechanical thrombectomy in patients with AIS.
期刊介绍：
The Journal of NeuroInterventional Surgery (JNIS) is a leading peer review journal for scientific research and literature pertaining to the field of neurointerventional surgery. The journal launch follows growing professional interest in neurointerventional techniques for the treatment of a range of neurological and vascular problems including stroke, aneurysms, brain tumors, and spinal compression.The journal is owned by SNIS and is also the official journal of the Interventional Chapter of the Australian and New Zealand Society of Neuroradiology (ANZSNR), the Canadian Interventional Neuro Group, the Hong Kong Neurological Society (HKNS) and the Neuroradiological Society of Taiwan.
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