NCT06341361

OCT-based Machine Learning FFR for Predicting Post-PCI FFR

Optical Coherence Tomography-based Machine Learning for Predicting Fractional Flow Reserve After Coronary Artery Stenting

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 82 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the diagnostic accuracy of the fractional flow reserve (FFR) model derived by machine learning based on optical coherence tomography (OCT) exam after coronary artery stent implantation with the wire-based FFR.

Detailed description

FFR and OCT exam are used for different purposes during percutaneous coronary intervention (PCI). The FFR is a decision-making tool to determine if additional procedures are necessary, while the OCT exam is used to optimize the stent procedure. The use of both tests provides additional information to help perform a excellent procedure, but it is more expensive and time-consuming. Therefore, an OCT-derived machine learning FFR test may be helpful. Previous studies have demonstrated that OCT-based machine learning FFR before the procedure has shown good diagnostic performance in predicting FFR, irrespective of the coronary territory. Despite the rapid development of technologies and tools for PCI, a significant number of patients experienced adverse events, such as recurrence of angina and silent ischemia despite angiographically successful PCI. Suboptimal PCI is a well-known independent prognostic factor for major cardiovascular accidents. Therefore, measuring post-PCI FFR immediately after stent implantation is crucial to optimize the procedure outcome and improve the patient's prognosis. Although the importance of measuring post-PCI FFR is gradually emerging, there is currently no model for OCT-based machine learning FFR that predicts FFR after stent insertion. In patients who underwent percutaneous coronary intervention using stents for ischemic heart disease, we will compare the diagnostic accuracy of the fractional flow reserve (FFR) model derived by machine learning based on optical coherence tomography (OCT) exam after coronary artery stent implantation with the wire-based FFR.

Conditions

• Tomography, Optical Coherence
• Fractional Flow Reserve, Myocardial

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	OCT-based machine learning FFR	OCT-based machine learning FFR and wire-based FFR

Timeline

• Start date: 2024-04-15
• Primary completion: 2024-04-30
• Completion: 2025-10-15
• First posted: 2024-04-02
• Last updated: 2024-04-02