Fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation (FLASH): Study protocol for a randomized controlled noninferiority trial
Study context
- Population
- Patients with significant CAD undergoing PCI, 13 centres in South Koreaplanned enrolment
- Participants
- 400 patients
- Planned comparison
- AI-QCA-assisted PCI vs OCT-guided PCI
- Primary endpoint
- Minimal stent area (mm²) by final OCT run
- Follow-up
- After completion of PCI
Methodological detailsinvestigator-initiated, multicentre, open-label, noninferiority, 1:1 randomisation, Clinical follow-up and cost-effectiveness evaluations planned at 1 and 6 months, Enrolment to be completed February 2024; follow-up August 2024; primary results expected late 2024
- Investigator-initiated
- Multicentre
- Open-label
- Noninferiority
- 1:1 randomisation
- Clinical follow-up and cost-effectiveness evaluations planned at 1 and 6 months
- Enrolment to be completed February 2024; follow-up August 2024; primary results expected late 2024
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation (FLASH): Study protocol for a randomized controlled noninferiority trial. Am Heart J. Published 7 May 2024. doi:10.
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