Minimal anonymized interim dataset (ongoing) for the Biotube Maker (BTM1) clinical trial

This dataset accompanies the study protocol entitled “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.” The dataset includes minimal anonymized interim data derived from the ongoing investigator-initiated multicenter clinical trial evaluating the Biotube Maker (BTM1) and Biotube® regenerative vascular grafts in patients with chronic limb-threatening ischemia (CLTI). The dataset structure reflects the variables described in the protocol, such as patient demographics, implant site, Biotube formation, implantation status, patency, wound healing, pain improvement, and limb salvage outcomes. “Ongoing” indicates cases still under follow-up, while “not_enrolled” refers to subjects yet to be recruited. The full anonymized dataset will be deposited upon completion of patient enrollment and final analysis, in accordance with ethical and legal requirements.