A prospective, multicentre, registry study of RECO in the endovascular treatment of acute ischaemic stroke
Abstract The RECO is a novel endovascular treatment (EVT) device that adjusts the distance between two mesh segments to axially hold the thrombus. We organized this postmarket study to assess the safety and performance of RECO in acute ischaemic stroke (AIS) patients with large vessel occlusion (LVO...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2024-01-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-024-52207-z |
| _version_ | 1797276574549016576 |
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| author | Yunlong Ding Tingting Zhai Ronghua Chen Fangshu Chen Yanbo Cheng Shiguang Zhu Yajie Liu Guodong Xiao Yunfeng Zhang Yan Liu Zhongrong Miao Jiali Niu |
| author_facet | Yunlong Ding Tingting Zhai Ronghua Chen Fangshu Chen Yanbo Cheng Shiguang Zhu Yajie Liu Guodong Xiao Yunfeng Zhang Yan Liu Zhongrong Miao Jiali Niu |
| author_sort | Yunlong Ding |
| collection | DOAJ |
| description | Abstract The RECO is a novel endovascular treatment (EVT) device that adjusts the distance between two mesh segments to axially hold the thrombus. We organized this postmarket study to assess the safety and performance of RECO in acute ischaemic stroke (AIS) patients with large vessel occlusion (LVO). This was a single-arm prospective multicentre study that enrolled patients as first-line patients treated with RECO at 9 stroke centres. The primary outcome measures included functional independence at 90 days (mRS 0–2), symptomatic intracranial haemorrhage (sICH), time from puncture to recanalization and time from symptom onset to recanalization. The secondary outcome measures were a modified thrombolysis in cerebral infarction (mTICI) score of 2b or 3 after the first attempt and at the end of the procedure and the all-cause mortality rate within 90 days. From May 22, 2020, to July 30, 2022, a total of 268 consecutive patients were enrolled in the registry. The median puncture-to-recanalization time was 64 (IQR, 45–92), and the symptom onset-to-recanalization time was 328 min (IQR, 228–469). RECO achieved successful reperfusion (mTICI 2b-3) after the first pass in 133 of 268 patients (49.6%). At the end of the operation, 96.6% of the patients reached mTICI 2b-3, and 97.4% of the patients ultimately achieved successful reperfusion. Sixteen (7.2%) patients had sICH. A total of 132 (49.3%) patients achieved functional independence at 90 days, and the all-cause mortality rate within 90 days was 17.5%. In this clinical experience, the RECO device achieved a high rate of complete recanalization with a good safety profile and favourable 90-day clinical outcomes. Clinical trial registration: URL: https://www.clinicaltrials.gov/ ; Unique identifier: NCT04840719. |
| first_indexed | 2024-03-07T15:30:08Z |
| format | Article |
| id | doaj.art-dca2b84f38624e278e5504c9b5b89161 |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-03-07T15:30:08Z |
| publishDate | 2024-01-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-dca2b84f38624e278e5504c9b5b891612024-03-05T16:28:48ZengNature PortfolioScientific Reports2045-23222024-01-011411810.1038/s41598-024-52207-zA prospective, multicentre, registry study of RECO in the endovascular treatment of acute ischaemic strokeYunlong Ding0Tingting Zhai1Ronghua Chen2Fangshu Chen3Yanbo Cheng4Shiguang Zhu5Yajie Liu6Guodong Xiao7Yunfeng Zhang8Yan Liu9Zhongrong Miao10Jiali Niu11Department of Neurology, JingJiang People’s Hospital, The Seventh Affiliated Hospital of Yangzhou UniversityDepartment of Neurology, JingJiang People’s Hospital, The Seventh Affiliated Hospital of Yangzhou UniversityDepartment of Neurosurgery, The First People’s Hospital of ChangzhouDepartment of Neurology, Ji’nan Zhangqiu District People’s HospitalDepartment of Neurology, The Affiliated Hospital of Xuzhou Medical University (East Hospital District)Department of Neurology, The Affiliated Hospital of Xuzhou Medical UniversityDepartment of Neurology, Southern Medical University Shenzhen HospitalDepartment of Neurology, Second Affiliated Hospital of Soochow UniversityDepartment of Neurology, Affiliated Hospital of Nantong UniversityDepartment of Neurology, JingJiang People’s Hospital, The Seventh Affiliated Hospital of Yangzhou UniversityDepartment of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical UniversityDepartment of Clinical Pharmacy, Jingjiang People’s Hospital, The Seventh Affiliated Hospital of Yangzhou UniversityAbstract The RECO is a novel endovascular treatment (EVT) device that adjusts the distance between two mesh segments to axially hold the thrombus. We organized this postmarket study to assess the safety and performance of RECO in acute ischaemic stroke (AIS) patients with large vessel occlusion (LVO). This was a single-arm prospective multicentre study that enrolled patients as first-line patients treated with RECO at 9 stroke centres. The primary outcome measures included functional independence at 90 days (mRS 0–2), symptomatic intracranial haemorrhage (sICH), time from puncture to recanalization and time from symptom onset to recanalization. The secondary outcome measures were a modified thrombolysis in cerebral infarction (mTICI) score of 2b or 3 after the first attempt and at the end of the procedure and the all-cause mortality rate within 90 days. From May 22, 2020, to July 30, 2022, a total of 268 consecutive patients were enrolled in the registry. The median puncture-to-recanalization time was 64 (IQR, 45–92), and the symptom onset-to-recanalization time was 328 min (IQR, 228–469). RECO achieved successful reperfusion (mTICI 2b-3) after the first pass in 133 of 268 patients (49.6%). At the end of the operation, 96.6% of the patients reached mTICI 2b-3, and 97.4% of the patients ultimately achieved successful reperfusion. Sixteen (7.2%) patients had sICH. A total of 132 (49.3%) patients achieved functional independence at 90 days, and the all-cause mortality rate within 90 days was 17.5%. In this clinical experience, the RECO device achieved a high rate of complete recanalization with a good safety profile and favourable 90-day clinical outcomes. Clinical trial registration: URL: https://www.clinicaltrials.gov/ ; Unique identifier: NCT04840719.https://doi.org/10.1038/s41598-024-52207-z |
| spellingShingle | Yunlong Ding Tingting Zhai Ronghua Chen Fangshu Chen Yanbo Cheng Shiguang Zhu Yajie Liu Guodong Xiao Yunfeng Zhang Yan Liu Zhongrong Miao Jiali Niu A prospective, multicentre, registry study of RECO in the endovascular treatment of acute ischaemic stroke Scientific Reports |
| title | A prospective, multicentre, registry study of RECO in the endovascular treatment of acute ischaemic stroke |
| title_full | A prospective, multicentre, registry study of RECO in the endovascular treatment of acute ischaemic stroke |
| title_fullStr | A prospective, multicentre, registry study of RECO in the endovascular treatment of acute ischaemic stroke |
| title_full_unstemmed | A prospective, multicentre, registry study of RECO in the endovascular treatment of acute ischaemic stroke |
| title_short | A prospective, multicentre, registry study of RECO in the endovascular treatment of acute ischaemic stroke |
| title_sort | prospective multicentre registry study of reco in the endovascular treatment of acute ischaemic stroke |
| url | https://doi.org/10.1038/s41598-024-52207-z |
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