The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

On-line three-dimensional OFDI guided PCI vs. angiography guided in bifurcation lesions: design and rationale of the randomized OPTIMUM trial

DOI: 10.4244/EIJ-D-18-00902

1. Thoraxcenter, Erasmus Medical Center Rotterdam, Rotterdam, the Netherlands
2. Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate
School of Medicine, Ube, Japan
3. Department of Cardiology, Cardiovascular Center, Fujita Health University Hospital, Toyoake, Japan
4. Department of cardiology, Academic Medical Center, Amsterdam, the Netherlands
5. Osaka Police Hospital, Osaka, Japan
6. Division of Cardiology, Teikyo University School of Medicine
7. International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom
8. Cardialysis Clinical Trials Management and Core Laboratories, Rotterdam, the Netherlands


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The aims of this trial is to determine the superiority of on-line three-dimensional optical frequency domain imaging (3D-OFDI) guided percutaneous coronary intervention (PCI) to angiography-guided PCI in bifurcation lesions. The OPTIMUM trial is a randomized, active control, superiority, and multi-center clinical trial. The primary endpoint is the post-procedural percentage of malapposed struts assessed by OFDI in the main branch bifurcation region after final kissing-balloon-dilatation. A total 106 patients will be randomly allocated to either 3D-OFDI or angiography guidance PCI. OPTIMUM trial will be the first prospective, randomised trial and evaluate the efficacy and safety of the on-line 3D-OFDI guided PCI.

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