The OPTIMAL trial is a randomized, controlled, multicentre, international, post-marketing strategy trial. The hypothesis is that an IVUS-guided approach is superior to a qualitative angio-guided approach in the setting of left-main PCI.
A total of 800 patients will be randomized in a 1:1 fashion after eligibility confirmation. Participants are followed up for 2 years after the index procedure. Up to 30 sites in Europe will participate in this study.
The OPTIMAL trial is performed in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP), ISO 14155:2020, EC requirements and country specific regulations.