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Safety and efficacy of an iBTA-induced autologous Biotube vascular graft and its preparation device BTM1 in below-the-knee bypass surgery for chronic limb threatening ischemia: A protocol for an open-label, single-arm, multicenter clinical trial.

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Title: Safety and efficacy of an iBTA-induced autologous Biotube vascular graft and its preparation device BTM1 in below-the-knee bypass surgery for chronic limb threatening ischemia: A protocol for an open-label, single-arm, multicenter clinical trial.
Authors: Shuto T; Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan., Higashita R; Department of Cardiovascular Surgery, Yokohama General Hospital, Yokohama, Kanagawa, Japan., Sako H; Department of Cardiovascular Surgery, Oita Oka Hospital, Oita, Oita, Japan., Abe F; Department of Development Promotion, Clinical Research, Innovation and Education Center (CRIETO), Tohoku University Hospital, Sendai, Miyagi, Japan., Yabuuchi N; Department of Development Promotion, Clinical Research, Innovation and Education Center (CRIETO), Tohoku University Hospital, Sendai, Miyagi, Japan., Umeno T; Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan., Mori K; Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan., Kawashima T; Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan., Nakashima Y; Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan., Nakayama Y; Osaka Laboratory, Biotube Co., Ltd. 302 Kansai University Center for Innovation and Creativity, Suita, Osaka, Japan., Miyamoto S; Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan.
Source: PloS one [PLoS One] 2025 Nov 06; Vol. 20 (11), pp. e0335900. Date of Electronic Publication: 2025 Nov 06 (Print Publication: 2025).
Publication Type: Journal Article; Clinical Trial Protocol
Journal Info: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Safety and efficacy of an iBTA-induced autologous Biotube vascular graft and its preparation device BTM1 in below-the-knee bypass surgery for chronic limb threatening ischemia: A protocol for an open-label, single-arm, multicenter clinical trial.
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  Data: <searchLink fieldCode="AU" term="%22Shuto+T%22">Shuto T</searchLink>; Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan.<br /><searchLink fieldCode="AU" term="%22Higashita+R%22">Higashita R</searchLink>; Department of Cardiovascular Surgery, Yokohama General Hospital, Yokohama, Kanagawa, Japan.<br /><searchLink fieldCode="AU" term="%22Sako+H%22">Sako H</searchLink>; Department of Cardiovascular Surgery, Oita Oka Hospital, Oita, Oita, Japan.<br /><searchLink fieldCode="AU" term="%22Abe+F%22">Abe F</searchLink>; Department of Development Promotion, Clinical Research, Innovation and Education Center (CRIETO), Tohoku University Hospital, Sendai, Miyagi, Japan.<br /><searchLink fieldCode="AU" term="%22Yabuuchi+N%22">Yabuuchi N</searchLink>; Department of Development Promotion, Clinical Research, Innovation and Education Center (CRIETO), Tohoku University Hospital, Sendai, Miyagi, Japan.<br /><searchLink fieldCode="AU" term="%22Umeno+T%22">Umeno T</searchLink>; Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan.<br /><searchLink fieldCode="AU" term="%22Mori+K%22">Mori K</searchLink>; Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan.<br /><searchLink fieldCode="AU" term="%22Kawashima+T%22">Kawashima T</searchLink>; Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan.<br /><searchLink fieldCode="AU" term="%22Nakashima+Y%22">Nakashima Y</searchLink>; Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan.<br /><searchLink fieldCode="AU" term="%22Nakayama+Y%22">Nakayama Y</searchLink>; Osaka Laboratory, Biotube Co., Ltd. 302 Kansai University Center for Innovation and Creativity, Suita, Osaka, Japan.<br /><searchLink fieldCode="AU" term="%22Miyamoto+S%22">Miyamoto S</searchLink>; Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan.
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  Data: <searchLink fieldCode="JN" term="%22101285081%22">PloS one</searchLink> [PLoS One] 2025 Nov 06; Vol. 20 (11), pp. e0335900. <i>Date of Electronic Publication: </i>2025 Nov 06 (<i>Print Publication: </i>2025).
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