Trial reportEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2023
First-in-human evaluation of a novel ultrathin sirolimus-eluting iron bioresorbable scaffold: 3-year outcomes of the IBS-FIM trial.
Trial report in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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Who cites it
17 citing papers in PubMed.
- Learning from Biodegradable Coronary Stents: Future Directions for TPVR Biodegradable Stents.International journal of molecular sciences · 2026Review
- Balloon-expandable trilayer nitrided iron/Zn/poly-D,L-lactic acid metallic tracheal stent: structural characterization, mechanical performance, and short-term safety evaluation in rabbits.Journal of thoracic disease · 2026Article
- Iron-Based Bioresorbable Scaffold in Contemporary: A Viewpoint on Design Rationale, Early Evidence, and Unresolved Questions.JACC. Asia · 2026Article
- Bioresorbable Scaffolds: Ready for a Rematch?Current cardiology reports · 2026Review
- Effects of molecular weight, end group of polylactide and coating thickness on corrosion rate and inhomogeneity of iron under biomimetic conditions.Regenerative biomaterials · 2026Article
- Development and translation of biodegradable metal stents: from heart to brain.Regenerative biomaterials · 2026Review
- Biodegradable Metal-Based Stents: Advances, Challenges, and Prospects.Journal of functional biomaterials · 2025Review
- Evaluation of FeMnN alloy bioresorbable flow diverting stents in the rabbit abdominal aorta.Bioactive materials · 2025Article
- Progress in research and development of biodegradable metallic vascular stents.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024Review
- Biodegradable high-nitrogen iron alloy anastomotic staples:Bioactive materials · 2024Article
- Radiopaque FeMnN-Mo composite drawn filled tubing wires for braided absorbable neurovascular devices.Bioactive materials · 2024Article
- Recognizing and preventing complications regarding bioresorbable scaffolds during coronary interventions.World journal of cardiology · 2024Article
- Maglev-fabricated long and biodegradable stent for interventional treatment of peripheral vessels.Nature communications · 2024Article
- Long-term efficacy, safety and biocompatibility of a novel sirolimus eluting iron bioresorbable scaffold in a porcine model.Bioactive materials · 2024Article
- Insights into the biocompatibility of biodegradable metallic molybdenum for cardiovascular applications-a critical review.Frontiers in bioengineering and biotechnology · 2024Review
- Effects of serum proteins on corrosion rates and product bioabsorbability of biodegradable metals.Regenerative biomaterials · 2024Article
- Novel bioresorbable scaffolds and lessons from recent history.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023Article
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Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe first-generation polymeric bioresorbable scaffolds resulted in higher than acceptable 3-year rates of device-related adverse outcomes.
aimsWe aimed to assess the intermediate-term safety and performance of a novel ultrathin-strut sirolimus-eluting iron bioresorbable scaffold (IBS) in non-complex coronary lesions.
methodsThe prospective, single-arm, open-label IBS first-in-human study enrolled 45 patients, each with a single de novo lesion. Enrolled patients were randomly assigned to 2 follow-up cohorts. Angiographic and imaging follow-up with intravascular ultrasound and optical coherence tomography (OCT) were conducted at 6 and 24 months in cohort 1 (n=30) and at 12 and 36 months in cohort 2 (n=15). Clinical follow-up was conducted at 1, 6 and 12 months, and annually thereafter up to 5 years. The coprimary outcomes were target lesion failure (TLF) and angiographic late lumen loss (LLL) at 6 months.
resultsA total of 45 patients were enrolled between April 2018 and January 2019. The mean age was 53.2 years, 77.8% were male, and 26.7% had diabetes. The TLF rates were 2.2% at 6 months and 6.7% at 3 years, which in all cases were due to clinically indicated target lesion revascularisation. No deaths, myocardial infarctions or stent thromboses occurred during 3-year follow-up. In-scaffold LLL was 0.33±0.27 mm at 6 months and 0.37±0.57 mm at 3 years. By OCT, the proportion of covered struts was 99.8% at 6 months and 100% after 1 year. The 3-year strut absorption rate was 95.4%.
conclusionsIn this first-in-human experience, an ultrathin IBS was safe and effective for the treatment of de novo non-complex coronary lesions up to 3-year follow-up.
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