NCT05829889

Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease

A Comparison of Fractional Flow Reserve- Versus Angiography-Guided Percutaneous Coronary Intervention in Patients With Left Main Coronary Artery Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 960 (estimated)
• Sponsor: Seung-Jung Park · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study was to determine whether the 2-year probability of major adverse cardiac events (primary composite outcome) differed significantly between patients who underwent angiography-guided Percutaneous Coronary Intervention(PCI) and those who underwent Fractional Flow Reserve(FFR)-guided PCI in patients with Left Main Coronary Artery disease(LMCA).

Detailed description

All participants will be monitored over a span of two years and the time point of the year of last subject last visit. The term "year of last subject last visit" refers to the time point of the last visit for all participants. At this specific time point, event occurrence check will be conducted to determine the occurrence of endpoint events among all participants.

Conditions

• Coronary Artery Disease Left Main
• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	FFR-Guided PCI	Fractional Flow Reserve-Guided PCI
PROCEDURE	Angiography-Guided PCI	Angiography-Guided PCI

Timeline

• Start date: 2024-04-25
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2023-04-26
• Last updated: 2025-12-29

Locations

48 sites across 5 countries: Hong Kong, India, Japan, South Korea, Taiwan