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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Bibliographic Details
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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