Randomized Clinical Trial of Extending the Time Window of Endovascular Therapy in the Triage of Late Presenting Stroke Beyond 24 h (SKIP-EXTEND): Rationale and Study Protocol
The therapeutic time window for endovascular therapy in acute stroke patients with large-vessel occlusion was extended to 24 hours from onset. Although a retrospective study showed the efficacy of endovascular therapy beyond 24 hours from the last known well, it remains unclear whether endovascular...
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The Japan Neurosurgical Society
2025-03-01
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| Series: | Neurologia Medico-Chirurgica |
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| Online Access: | https://www.jstage.jst.go.jp/article/nmc/65/3/65_2024-0196/_pdf/-char/en |
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| author | Kentaro SUZUKI Yuji MATSUMARU Masataka TAKEUCHI Masafumi MORIMOTO Junya KANEKO Keigo SHIGETA Tomoji TAKIGAWA Takehiro KATANO Junya AOKI Mikito HAYAKAWA Toshiaki OTSUKA Shigeru FUJIMOTO Koji IIHARA Kazumi KIMURA for the SKIP-EXTEND Trial Investigators |
| author_facet | Kentaro SUZUKI Yuji MATSUMARU Masataka TAKEUCHI Masafumi MORIMOTO Junya KANEKO Keigo SHIGETA Tomoji TAKIGAWA Takehiro KATANO Junya AOKI Mikito HAYAKAWA Toshiaki OTSUKA Shigeru FUJIMOTO Koji IIHARA Kazumi KIMURA for the SKIP-EXTEND Trial Investigators |
| author_sort | Kentaro SUZUKI |
| collection | DOAJ |
| description | The therapeutic time window for endovascular therapy in acute stroke patients with large-vessel occlusion was extended to 24 hours from onset. Although a retrospective study showed the efficacy of endovascular therapy beyond 24 hours from the last known well, it remains unclear whether endovascular therapy is effective. Extending the time window of Endovascular therapy in the Triage of Late Presenting Strokes beyond 24 h (SKIP-EXTEND trial) aimed to clarify the efficacy of endovascular therapy compared to the best medical management. This is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded end-point clinical trial. Eligibility criteria included adults and pre-stroke modified Rankin scale score 2 with internal carotid artery or M1 (horizontal or sphenoidal segment) occlusion beyond 24 to 72 hours of the last known well. The target enrollment is 260 patients, with 130 reeiving endovascular therapy and 130 receiving the best medical treatment. The primary outcome is the rate of favorable outcome defined as a modified Rankin scale score 2 at 90 days. The secondary outcomes are the ordinal logistic regression analysis of the modified Rankin scale score and the rate of recanalization at 48 hours. As safety outcomes, the rate of any and symptomatic intracranial hemorrhage at 24 hours and the rate of mortality at 90 days are assessed. This is the first randomized controlled trial to focus on the efficacy of endovascular therapy beyond 24 hours. Our results will not only benefit patients but also reduce healthcare costs. We believe that this novel study will be useful in clinical practice. |
| format | Article |
| id | doaj-art-e572183113534f7f9c7b049eb09f8830 |
| institution | DOAJ |
| issn | 1349-8029 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | The Japan Neurosurgical Society |
| record_format | Article |
| series | Neurologia Medico-Chirurgica |
| spelling | doaj-art-e572183113534f7f9c7b049eb09f88302025-08-20T03:05:43ZengThe Japan Neurosurgical SocietyNeurologia Medico-Chirurgica1349-80292025-03-0165315515910.2176/jns-nmc.2024-01962024-0196Randomized Clinical Trial of Extending the Time Window of Endovascular Therapy in the Triage of Late Presenting Stroke Beyond 24 h (SKIP-EXTEND): Rationale and Study ProtocolKentaro SUZUKI0Yuji MATSUMARU1Masataka TAKEUCHI2Masafumi MORIMOTO3Junya KANEKO4Keigo SHIGETA5Tomoji TAKIGAWA6Takehiro KATANO7Junya AOKI8Mikito HAYAKAWA9Toshiaki OTSUKA10Shigeru FUJIMOTO11Koji IIHARA12Kazumi KIMURA13for the SKIP-EXTEND Trial InvestigatorsDepartment of Neurology, Nippon Medical SchoolDepartment of Neurosurgery, Institute of Medicine, University of TsukubaDepartment of Neurosurgery, Seisho HospitalDepartment of Neurosurgery, Yokohama Shintoshi Neurosurgical HospitalDepartment of Emergency and Critical Care Medicine, Nippon Medical School Tama Nagayama HospitalDepartment of Neurosurgery, National Hospital Organization Disaster Medical CenterDepartment of Neurosurgery, Dokkyo Medical University Saitama Medical CenterDepartment of Neurology, Nippon Medical SchoolDepartment of Neurology, Nippon Medical SchoolDepartment of Neurology, Institute of Medicine, University of TsukubaDepartment of Hygiene and Public Health, Nippon Medical SchoolDivision of Neurology, Department of Medicine, Jichi Medical UniversityDepartment of Neurosurgery, National Cerebral and Cardiovascular CenterDepartment of Neurology, Nippon Medical SchoolThe therapeutic time window for endovascular therapy in acute stroke patients with large-vessel occlusion was extended to 24 hours from onset. Although a retrospective study showed the efficacy of endovascular therapy beyond 24 hours from the last known well, it remains unclear whether endovascular therapy is effective. Extending the time window of Endovascular therapy in the Triage of Late Presenting Strokes beyond 24 h (SKIP-EXTEND trial) aimed to clarify the efficacy of endovascular therapy compared to the best medical management. This is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded end-point clinical trial. Eligibility criteria included adults and pre-stroke modified Rankin scale score 2 with internal carotid artery or M1 (horizontal or sphenoidal segment) occlusion beyond 24 to 72 hours of the last known well. The target enrollment is 260 patients, with 130 reeiving endovascular therapy and 130 receiving the best medical treatment. The primary outcome is the rate of favorable outcome defined as a modified Rankin scale score 2 at 90 days. The secondary outcomes are the ordinal logistic regression analysis of the modified Rankin scale score and the rate of recanalization at 48 hours. As safety outcomes, the rate of any and symptomatic intracranial hemorrhage at 24 hours and the rate of mortality at 90 days are assessed. This is the first randomized controlled trial to focus on the efficacy of endovascular therapy beyond 24 hours. Our results will not only benefit patients but also reduce healthcare costs. We believe that this novel study will be useful in clinical practice.https://www.jstage.jst.go.jp/article/nmc/65/3/65_2024-0196/_pdf/-char/enrandomized clinical trialstrokeendovascular therapy24 hours |
| spellingShingle | Kentaro SUZUKI Yuji MATSUMARU Masataka TAKEUCHI Masafumi MORIMOTO Junya KANEKO Keigo SHIGETA Tomoji TAKIGAWA Takehiro KATANO Junya AOKI Mikito HAYAKAWA Toshiaki OTSUKA Shigeru FUJIMOTO Koji IIHARA Kazumi KIMURA for the SKIP-EXTEND Trial Investigators Randomized Clinical Trial of Extending the Time Window of Endovascular Therapy in the Triage of Late Presenting Stroke Beyond 24 h (SKIP-EXTEND): Rationale and Study Protocol Neurologia Medico-Chirurgica randomized clinical trial stroke endovascular therapy 24 hours |
| title | Randomized Clinical Trial of Extending the Time Window of Endovascular Therapy in the Triage of Late Presenting Stroke Beyond 24 h (SKIP-EXTEND): Rationale and Study Protocol |
| title_full | Randomized Clinical Trial of Extending the Time Window of Endovascular Therapy in the Triage of Late Presenting Stroke Beyond 24 h (SKIP-EXTEND): Rationale and Study Protocol |
| title_fullStr | Randomized Clinical Trial of Extending the Time Window of Endovascular Therapy in the Triage of Late Presenting Stroke Beyond 24 h (SKIP-EXTEND): Rationale and Study Protocol |
| title_full_unstemmed | Randomized Clinical Trial of Extending the Time Window of Endovascular Therapy in the Triage of Late Presenting Stroke Beyond 24 h (SKIP-EXTEND): Rationale and Study Protocol |
| title_short | Randomized Clinical Trial of Extending the Time Window of Endovascular Therapy in the Triage of Late Presenting Stroke Beyond 24 h (SKIP-EXTEND): Rationale and Study Protocol |
| title_sort | randomized clinical trial of extending the time window of endovascular therapy in the triage of late presenting stroke beyond 24 h skip extend rationale and study protocol |
| topic | randomized clinical trial stroke endovascular therapy 24 hours |
| url | https://www.jstage.jst.go.jp/article/nmc/65/3/65_2024-0196/_pdf/-char/en |
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