Coronary disease & ACS

Sirolimus-eluting iron bioresorbable scaffold versus cobalt-chromium everolimus-eluting stents in patients with coronary artery disease: Rationale and design of the IRONMAN-II trial

Am Heart JPublished Randomised controlled trial

Study context

Population
Patients with CAD
Participants
518 patients
Planned comparison
Sirolimus-eluting iron bioresorbable scaffold vs cobalt-chromium everolimus-eluting stent
  • Iron bioresorbable scaffold (IBS)n = 257
  • Drug-eluting stents (DES)n = 261reference
Primary endpoint
In-segment late lumen loss
Follow-up
2 years
Methodological detailsrationale and design, noninferiority, multicentre (36 centres, China), Major secondary endpoints: 2-year quantitative flow ratio and optical coherence tomography (OCT) cross-sectional mean flow area (OCT subgroup, 25 patients per group)
  • Rationale and design
  • Noninferiority
  • Multicentre (36 centres, China)
  • Major secondary endpoints: 2-year quantitative flow ratio and OCT cross-sectional mean flow area (OCT subgroup, 25 patients per group)

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Sirolimus-eluting iron bioresorbable scaffold versus cobalt-chromium everolimus-eluting stents in patients with coronary artery disease: Rationale and design of the IRONMAN-II trial. Am Heart J. Published 4 June 2024. doi:10.1016/j.ahj.2024.05.019

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