First-in-human trial of a self-expandable, temporary dilation system for intracranial atherosclerotic disease in patients presenting with acute ischemic stroke
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
BACKGROUND: Intracranial atherosclerotic disease (ICAD) significantly contributes to ischemic stroke, especially among Asian populations. Large vessel occlusion (LVO) due to underlying ICAD accounts for 15-35% of acute ischemic stroke cases requiring endovascular therapy. However, the successful recanalization rate of ICAD-related LVO remains lower. The TG dilator is a self-expandable device, temporarily dilating ICAD-related blocked blood vessels.
OBJECTIVE: To demonstrate TG dilator safety and efficacy for ICAD-related acute ischemic stroke.
METHODS: This was a single-arm, open-label, non-randomized, prospective, multicenter, and investigator-initiated trial that involved patients undergoing TG dilator application for acute ischemic stroke caused by ICAD-related LVO or severe stenosis.
RESULTS: We enrolled 10 patients in this trial between November 2022 and April 2023. The median (IQR) age was 68 (59.3-75.3) years. Before using the dilator, seven patients received stent retriever treatment. All 10 patients were prescribed a loading dose of aspirin with prasugrel. The median application time was 10 (10-12) min. At the end of the procedure, we achieved significant recanalization immediately in all patients. The stenosis/occlusion decreased from 100% (100-100) to 68% (56.3-75.3). No patient experienced recurrent ischemic stroke or reocclusion within 90 days. We achieved a modified Rankin scale score of 0-2 in 8 patients by day 90. We detected no cases of intracranial hemorrhage, equipment failure, distal embolism, vasospasm, dissection, or perforation requiring intervention.
CONCLUSIONS: Acute revascularization using the TG dilator on patients with ICAD-related LVO or severe stenosis did not cause any significant adverse event, and consistently improved blood flow at 90 days.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2023 |
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| Enthalten in: |
Journal of neurointerventional surgery - (2023) vom: 24. Nov. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Ohta, Tsuyoshi [VerfasserIn] |
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Date Revised 02.12.2023 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1136/jnis-2023-020983 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM365326550 |
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| 100 | 1 | |a Ohta, Tsuyoshi |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a First-in-human trial of a self-expandable, temporary dilation system for intracranial atherosclerotic disease in patients presenting with acute ischemic stroke |
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| 520 | |a © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a BACKGROUND: Intracranial atherosclerotic disease (ICAD) significantly contributes to ischemic stroke, especially among Asian populations. Large vessel occlusion (LVO) due to underlying ICAD accounts for 15-35% of acute ischemic stroke cases requiring endovascular therapy. However, the successful recanalization rate of ICAD-related LVO remains lower. The TG dilator is a self-expandable device, temporarily dilating ICAD-related blocked blood vessels | ||
| 520 | |a OBJECTIVE: To demonstrate TG dilator safety and efficacy for ICAD-related acute ischemic stroke | ||
| 520 | |a METHODS: This was a single-arm, open-label, non-randomized, prospective, multicenter, and investigator-initiated trial that involved patients undergoing TG dilator application for acute ischemic stroke caused by ICAD-related LVO or severe stenosis | ||
| 520 | |a RESULTS: We enrolled 10 patients in this trial between November 2022 and April 2023. The median (IQR) age was 68 (59.3-75.3) years. Before using the dilator, seven patients received stent retriever treatment. All 10 patients were prescribed a loading dose of aspirin with prasugrel. The median application time was 10 (10-12) min. At the end of the procedure, we achieved significant recanalization immediately in all patients. The stenosis/occlusion decreased from 100% (100-100) to 68% (56.3-75.3). No patient experienced recurrent ischemic stroke or reocclusion within 90 days. We achieved a modified Rankin scale score of 0-2 in 8 patients by day 90. We detected no cases of intracranial hemorrhage, equipment failure, distal embolism, vasospasm, dissection, or perforation requiring intervention | ||
| 520 | |a CONCLUSIONS: Acute revascularization using the TG dilator on patients with ICAD-related LVO or severe stenosis did not cause any significant adverse event, and consistently improved blood flow at 90 days | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Atherosclerosis | |
| 650 | 4 | |a Stroke | |
| 700 | 1 | |a Takeuchi, Masataka |e verfasserin |4 aut | |
| 700 | 1 | |a Yamagami, Hiroshi |e verfasserin |4 aut | |
| 700 | 1 | |a Tsuto, Kazuma |e verfasserin |4 aut | |
| 700 | 1 | |a Yamamoto, Shiro |e verfasserin |4 aut | |
| 700 | 1 | |a Asai, Katsunori |e verfasserin |4 aut | |
| 700 | 1 | |a Ishii, Akira |e verfasserin |4 aut | |
| 700 | 1 | |a Imamura, Hirotoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Yoshimura, Shinichi |e verfasserin |4 aut | |
| 700 | 1 | |a Fukumitsu, Ryu |e verfasserin |4 aut | |
| 700 | 1 | |a Sakai, Chiaki |e verfasserin |4 aut | |
| 700 | 1 | |a Sakai, Nobuyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Tateshima, Satoshi |e verfasserin |4 aut | |
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