Safety and efficacy of the SeparGateTM balloon-guiding catheter in neurointerventional surgery: A prospective, multicenter, single-arm clinical trial
Objective: To evaluate the safety and efficacy of the SeparGate™ balloon-guiding catheter (BGC) for blocking flow and delivering devices in neurointerventional surgery. Method: This prospective multicenter single-arm trial enrolled patients who received BGC adjuvant therapy to provide temporary bloo...
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| Format: | Article |
| Language: | English |
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KeAi Communications Co., Ltd.
2022-08-01
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| Series: | Journal of Interventional Medicine |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2096360222000370 |
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| author | Huan Liu Rufeng Jia Yanyan He Tengfei Zhou Liangfu Zhu Yonghong Ding Juha Antero Hernesniemi Tianxiao Li Yingkun He |
| author_facet | Huan Liu Rufeng Jia Yanyan He Tengfei Zhou Liangfu Zhu Yonghong Ding Juha Antero Hernesniemi Tianxiao Li Yingkun He |
| author_sort | Huan Liu |
| collection | DOAJ |
| description | Objective: To evaluate the safety and efficacy of the SeparGate™ balloon-guiding catheter (BGC) for blocking flow and delivering devices in neurointerventional surgery. Method: This prospective multicenter single-arm trial enrolled patients who received BGC adjuvant therapy to provide temporary blood flow arrest of the supra-aortic arch arteries and their branch vessels in interventional therapy. The primary endpoint was immediate procedural success rate in flow arrest, device delivery, and withdrawal. The efficacy endpoints were intraoperative product performance, including rigidity, smoothness, fracture resistance of the catheter wall, catheter push performance, compatibility and radiopaque display, integrity, adhesion thrombus after withdrawal and balloon rupture. The safety endpoints were adverse and serious adverse events associated with the test device and serious adverse events resulting in death or serious health deterioration. Result: A total of 129 patients were included; of them, 128 were analyzed in the full analysis set (FAS) and per protocol set (PPS). Immediate procedural success was achieved in 97.7% of patients with FAS and PPS. The lower bound of the 95% confidence interval was 94.6%, higher than the preset efficacy margin of 94%. Device-related adverse events occurred in 2 (1.6%) cases. One was mild adverse event of vasospasm, which resolved spontaneously. The other was serious adverse event of dissection aggravation, which was treated with stenting angioplasty. No device defects were observed. Conclusion: In neurointerventional surgery, the SeparGate™ BGC can be used to temporarily block the flow of the supra-aortic arch arteries and their branch vessels and guide the interventional device to the target vascular position. |
| first_indexed | 2024-04-11T21:14:45Z |
| format | Article |
| id | doaj.art-5ec3218fb75b49a3be3378413178e81d |
| institution | Directory Open Access Journal |
| issn | 2096-3602 |
| language | English |
| last_indexed | 2024-04-11T21:14:45Z |
| publishDate | 2022-08-01 |
| publisher | KeAi Communications Co., Ltd. |
| record_format | Article |
| series | Journal of Interventional Medicine |
| spelling | doaj.art-5ec3218fb75b49a3be3378413178e81d2022-12-22T04:02:50ZengKeAi Communications Co., Ltd.Journal of Interventional Medicine2096-36022022-08-0153143147Safety and efficacy of the SeparGateTM balloon-guiding catheter in neurointerventional surgery: A prospective, multicenter, single-arm clinical trialHuan Liu0Rufeng Jia1Yanyan He2Tengfei Zhou3Liangfu Zhu4Yonghong Ding5Juha Antero Hernesniemi6Tianxiao Li7Yingkun He8Department of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, 450003, ChinaDepartment of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, 450003, ChinaDepartment of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, 450003, ChinaDepartment of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, 450003, ChinaDepartment of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, 450003, ChinaDepartment of Radiology, Mayo Clinic, Rochester, MN, USA“Juha Hernesniemi” International Center for Neurosurgery, Henan Provincial People´s Hospital, Zhengzhou, ChinaDepartment of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, 450003, China; Corresponding author. Department of Cerebrovascular Disease, Zhengzhou University People's Hospital, No 7, Weiwu Road, Zhengzhou, Henan, 450003, China.Department of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, 450003, China; Corresponding author. Department of Cerebrovascular Disease, Zhengzhou University People's Hospital, No 7, Weiwu Road, Zhengzhou, Henan, 450003, China.Objective: To evaluate the safety and efficacy of the SeparGate™ balloon-guiding catheter (BGC) for blocking flow and delivering devices in neurointerventional surgery. Method: This prospective multicenter single-arm trial enrolled patients who received BGC adjuvant therapy to provide temporary blood flow arrest of the supra-aortic arch arteries and their branch vessels in interventional therapy. The primary endpoint was immediate procedural success rate in flow arrest, device delivery, and withdrawal. The efficacy endpoints were intraoperative product performance, including rigidity, smoothness, fracture resistance of the catheter wall, catheter push performance, compatibility and radiopaque display, integrity, adhesion thrombus after withdrawal and balloon rupture. The safety endpoints were adverse and serious adverse events associated with the test device and serious adverse events resulting in death or serious health deterioration. Result: A total of 129 patients were included; of them, 128 were analyzed in the full analysis set (FAS) and per protocol set (PPS). Immediate procedural success was achieved in 97.7% of patients with FAS and PPS. The lower bound of the 95% confidence interval was 94.6%, higher than the preset efficacy margin of 94%. Device-related adverse events occurred in 2 (1.6%) cases. One was mild adverse event of vasospasm, which resolved spontaneously. The other was serious adverse event of dissection aggravation, which was treated with stenting angioplasty. No device defects were observed. Conclusion: In neurointerventional surgery, the SeparGate™ BGC can be used to temporarily block the flow of the supra-aortic arch arteries and their branch vessels and guide the interventional device to the target vascular position.http://www.sciencedirect.com/science/article/pii/S2096360222000370SeparGateTM balloon guiding catheterSafety and efficacyNeurointerventional surgery |
| spellingShingle | Huan Liu Rufeng Jia Yanyan He Tengfei Zhou Liangfu Zhu Yonghong Ding Juha Antero Hernesniemi Tianxiao Li Yingkun He Safety and efficacy of the SeparGateTM balloon-guiding catheter in neurointerventional surgery: A prospective, multicenter, single-arm clinical trial Journal of Interventional Medicine SeparGateTM balloon guiding catheter Safety and efficacy Neurointerventional surgery |
| title | Safety and efficacy of the SeparGateTM balloon-guiding catheter in neurointerventional surgery: A prospective, multicenter, single-arm clinical trial |
| title_full | Safety and efficacy of the SeparGateTM balloon-guiding catheter in neurointerventional surgery: A prospective, multicenter, single-arm clinical trial |
| title_fullStr | Safety and efficacy of the SeparGateTM balloon-guiding catheter in neurointerventional surgery: A prospective, multicenter, single-arm clinical trial |
| title_full_unstemmed | Safety and efficacy of the SeparGateTM balloon-guiding catheter in neurointerventional surgery: A prospective, multicenter, single-arm clinical trial |
| title_short | Safety and efficacy of the SeparGateTM balloon-guiding catheter in neurointerventional surgery: A prospective, multicenter, single-arm clinical trial |
| title_sort | safety and efficacy of the separgatetm balloon guiding catheter in neurointerventional surgery a prospective multicenter single arm clinical trial |
| topic | SeparGateTM balloon guiding catheter Safety and efficacy Neurointerventional surgery |
| url | http://www.sciencedirect.com/science/article/pii/S2096360222000370 |
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