ArticlePloS one2025
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.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Reinforced biotubes as readily available and regenerative vascular grafts.Nature communications · 2026Article
- Don't judge an implant by its cover: how the foreign body response and fibrotic capsule might be harnessed for good.npj biomedical innovations · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeChronic limb-threatening ischemia (CLTI) increases the risk of lower limb amputation if revascularization is not performed. The use of autologous venous conduits is the only option for patients requiring below-the-knee bypass surgery, but it is limited by a lack of usable veins. The Biotube Maker (BTM1), based on in-Body Tissue Architecture (iBTA) technology, is a mold for the in vivo production of the Biotube® regenerative artificial vascular grafts. This clinical trial is designed to evaluate the safety and efficacy of subcutaneous embedding of the BTM1 for Biotube preparation and arterial bypass surgery using Biotube.
methodsPatients with CLTI who lack suitable veins for bypass surgery will be enrolled. This exploratory, investigator-initiated clinical trial will include 12 subjects. The primary endpoint is successful formation of an implantable Biotube following subcutaneous embedding of the BTM1. Secondary endpoints include intraoperative usability, patency and biocompatibility of the Biotube, wound healing, relief of rest pain, limb salvage, and procedure-related mortality, assessed up to 12 weeks after surgery. These outcomes are expected to provide essential feasibility and safety data to guide future pivotal studies. DISCUSSION: This study may offer a new treatment option for CLTI patients who otherwise face major amputation. If feasibility and safety are confirmed, the findings will support planning of a pivotal trial aimed at regulatory approval.
trial registrationjRCT2072220062. Registered on October 19, 2022.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.