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

• Takashi Shuto ,

  Roles Investigation, Writing – original draft, Writing – review & editing

  * E-mail: shutot@oita-u.ac.jp

  Affiliation Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan

  https://orcid.org/0000-0002-7150-4519

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• Ryuji Higashita,

  Roles Data curation, Investigation, Validation

  Affiliation Department of Cardiovascular Surgery, Yokohama General Hospital, Yokohama, Kanagawa, Japan

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• Hidenori Sako,

  Roles Data curation, Investigation, Validation

  Affiliation Department of Cardiovascular Surgery, Oita Oka Hospital, Oita, Oita, Japan

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• Fumie Abe,

  Roles Methodology

  Affiliation Department of Development Promotion, Clinical Research, Innovation and Education Center (CRIETO), Tohoku University Hospital, Sendai, Miyagi, Japan

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• Nozomi Yabuuchi,

  Roles Methodology

  Affiliation Department of Development Promotion, Clinical Research, Innovation and Education Center (CRIETO), Tohoku University Hospital, Sendai, Miyagi, Japan

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• Tadashi Umeno,

  Roles Data curation, Investigation

  Affiliation Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan

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• Kazuki Mori,

  Roles Data curation, Investigation

  Affiliation Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan

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• Takayuki Kawashima,

  Roles Data curation, Investigation

  Affiliation Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan

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• Yumiko Nakashima,

  Roles Project administration

  Affiliation Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan

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• Yasuhide Nakayama,

  Roles Conceptualization, Funding acquisition, Methodology, Resources, Validation, Visualization

  Affiliation Osaka Laboratory, Biotube Co., Ltd. 302 Kansai University Center for Innovation and Creativity, Suita, Osaka, Japan

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• Shinji Miyamoto

  Roles Conceptualization, Funding acquisition, Methodology, Supervision

  Affiliation Department of Cardiovascular Surgery, Oita University Hospital, Yufu, Oita, Japan

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