Endovascular therapy in acute anterior circulation large vessel occlusive patients with a large infarct core (ANGEL-ASPECT): protocol of a multicentre randomised trial
Background The benefit of stroke thrombectomy for large infarct core still lacks robust randomised controlled studies.Aim To demonstrate the design of a clinical trial on endovascular therapy for acute anterior circulation large vessel occlusion (LVO) patients with large infarct core volume.Design A...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
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| Series: | Stroke and Vascular Neurology |
| Online Access: | https://svn.bmj.com/content/early/2022/09/22/svn-2022-001865.full |
| _version_ | 1797996750647066624 |
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| author | Liping Liu Yongjun Wang Yilong Wang Zhongrong Miao David S Liebeskind Vitor Mendes Pereira Zeguang Ren Xiaochuan Huo Yuesong Pan Xuelei Zhang Gaoting Ma Xu Tong Dapeng Sun |
| author_facet | Liping Liu Yongjun Wang Yilong Wang Zhongrong Miao David S Liebeskind Vitor Mendes Pereira Zeguang Ren Xiaochuan Huo Yuesong Pan Xuelei Zhang Gaoting Ma Xu Tong Dapeng Sun |
| author_sort | Liping Liu |
| collection | DOAJ |
| description | Background The benefit of stroke thrombectomy for large infarct core still lacks robust randomised controlled studies.Aim To demonstrate the design of a clinical trial on endovascular therapy for acute anterior circulation large vessel occlusion (LVO) patients with large infarct core volume.Design ANGEL-ASPECT is a multicentre, prospective, randomised, open-label, blinded End-point trial to evaluate whether best medical management (BMM) combined with endovascular therapy improves neurological functional outcomes as compared with BMM alone in acute LVO patients with Alberta Stroke Program Early CT Score (ASPECTS) of 3–5 on non-contrast CT or infarct core volume range of 70–100 mL (defined as rCBF <30% on CT perfusion or ADC <620 on MRI) up to 24 hours from symptom onset or last seen well.Study outcomes The primary efficacy outcome is 90 (±7) days modified Rankin Scale. Symptomatic intracranial haemorrhage within 48 hours from randomisation is the primary safety outcome.Discussion The ANGEL-ASPECT trial will screen patients with large infarct core (ASPECTS 3–5 or 70–100 mL) through image evaluation criteria within 24 hours and explore the efficacy and safety of endovascular therapy compared with BMM. |
| first_indexed | 2024-04-11T10:22:27Z |
| format | Article |
| id | doaj.art-224ec1b4ec2a403ba26a31ffc17b3e44 |
| institution | Directory Open Access Journal |
| issn | 2059-8696 |
| language | English |
| last_indexed | 2024-04-11T10:22:27Z |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Stroke and Vascular Neurology |
| spelling | doaj.art-224ec1b4ec2a403ba26a31ffc17b3e442022-12-22T04:29:41ZengBMJ Publishing GroupStroke and Vascular Neurology2059-869610.1136/svn-2022-001865Endovascular therapy in acute anterior circulation large vessel occlusive patients with a large infarct core (ANGEL-ASPECT): protocol of a multicentre randomised trialLiping Liu0Yongjun Wang1Yilong Wang2Zhongrong Miao3David S Liebeskind4Vitor Mendes Pereira5Zeguang Ren6Xiaochuan Huo7Yuesong Pan8Xuelei Zhang9Gaoting Ma10Xu Tong11Dapeng Sun12Hunan Cancer Hospital, Central South University, Changsha, ChinaDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China2 Department of Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China22 Neurology, University of California, Los Angeles, Los Angeles, California, USA46 Neurosurgery, Medical Imaging, Surgery, University of Toronto, Toronto, Ontario, CanadaDepartment of Neurosurgery, Cleveland Clinic Martin Health, Port St Lucie, Florida, USA1 Department of Interventional Neuroradiology, Beijing Neurosurgical Institute and Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaBeijing Institute of Brain Disorders, Capital Medical University, Beijing, ChinaDepartment of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaBackground The benefit of stroke thrombectomy for large infarct core still lacks robust randomised controlled studies.Aim To demonstrate the design of a clinical trial on endovascular therapy for acute anterior circulation large vessel occlusion (LVO) patients with large infarct core volume.Design ANGEL-ASPECT is a multicentre, prospective, randomised, open-label, blinded End-point trial to evaluate whether best medical management (BMM) combined with endovascular therapy improves neurological functional outcomes as compared with BMM alone in acute LVO patients with Alberta Stroke Program Early CT Score (ASPECTS) of 3–5 on non-contrast CT or infarct core volume range of 70–100 mL (defined as rCBF <30% on CT perfusion or ADC <620 on MRI) up to 24 hours from symptom onset or last seen well.Study outcomes The primary efficacy outcome is 90 (±7) days modified Rankin Scale. Symptomatic intracranial haemorrhage within 48 hours from randomisation is the primary safety outcome.Discussion The ANGEL-ASPECT trial will screen patients with large infarct core (ASPECTS 3–5 or 70–100 mL) through image evaluation criteria within 24 hours and explore the efficacy and safety of endovascular therapy compared with BMM.https://svn.bmj.com/content/early/2022/09/22/svn-2022-001865.full |
| spellingShingle | Liping Liu Yongjun Wang Yilong Wang Zhongrong Miao David S Liebeskind Vitor Mendes Pereira Zeguang Ren Xiaochuan Huo Yuesong Pan Xuelei Zhang Gaoting Ma Xu Tong Dapeng Sun Endovascular therapy in acute anterior circulation large vessel occlusive patients with a large infarct core (ANGEL-ASPECT): protocol of a multicentre randomised trial Stroke and Vascular Neurology |
| title | Endovascular therapy in acute anterior circulation large vessel occlusive patients with a large infarct core (ANGEL-ASPECT): protocol of a multicentre randomised trial |
| title_full | Endovascular therapy in acute anterior circulation large vessel occlusive patients with a large infarct core (ANGEL-ASPECT): protocol of a multicentre randomised trial |
| title_fullStr | Endovascular therapy in acute anterior circulation large vessel occlusive patients with a large infarct core (ANGEL-ASPECT): protocol of a multicentre randomised trial |
| title_full_unstemmed | Endovascular therapy in acute anterior circulation large vessel occlusive patients with a large infarct core (ANGEL-ASPECT): protocol of a multicentre randomised trial |
| title_short | Endovascular therapy in acute anterior circulation large vessel occlusive patients with a large infarct core (ANGEL-ASPECT): protocol of a multicentre randomised trial |
| title_sort | endovascular therapy in acute anterior circulation large vessel occlusive patients with a large infarct core angel aspect protocol of a multicentre randomised trial |
| url | https://svn.bmj.com/content/early/2022/09/22/svn-2022-001865.full |
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