NCT05250557

Prognostic Impact of Lesion-specific Hemodynamic Index in Patients With Coronary Artery Disease

Prognostic Impact of Lesion-specific Hemodynamic Index and Disease Characteristics in Patients With Coronary Artery Disease Assessed by Fractional Flow Reserve

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,429 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to investigate the additive prognostic value of lesion-specific hemodynamic index such as ΔFFR, non-hyperemic pressure ratio such as RFR, over % diameter stenosis and FFR according to treatment strategy, and to find the prognostic implications of post-PCI FFR after adjustment of various clinical and disease characteristics, and to construct a comprehensive risk prediction model for post-PCI outcomes.

Detailed description

Fractional flow reserve (FFR)-based revascularization is the currently best practice recommended by guidelines. In addition to the use of coronary physiological indices as a vessel-specific metric, recent studies suggested the clinical importance of local hemodynamics in prediction of risk for target vessel failure or acute coronary syndrome in patients with coronary artery disease. In patients who receive percutaneous coronary intervention (PCI), the absolute value and pattern of FFR change after stenting are helpful in defining the additional target for PCI and risk stratification after PCI. However, there has been no prospective study that proved the benefit of change in FFR across the lesion (ΔFFR) in daily clinical practice, and FFR usage after stenting is much less than before stenting. Accordingly, we will prove the benefit of ΔFFR in addition to FFR, prognostic implications of combining RFR and FFR, and the comprehensive risk model with post-PCI FFR, clinical and disease characteristics in a prospective study, to maximize the benefit of invasive physiologic assessment.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fractional flow reserve	Physiologic assessment includes Δ FFR (lesion-specific) and FFR (vessel-specific) measurement. Δ FFR is defined as a pressure step up across the lesion. Coronary angiography and physiologic assessment will be analyzed by an independent core laboratory (Seoul National University Hospital, Clinical Trial Center, Seoul, South Korea).

Timeline

• Start date: 2021-08-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2022-02-22
• Last updated: 2022-02-22

Locations

1 site across 1 country: South Korea