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

NCT05250557 · tracked via the Priya Life Science South Korea tracker

Sponsor

Seoul National University Hospital

Phase

Observational

Started

2021-08-01

Last updated

2022-02-22

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Fractional flow reserve

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).

Study 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.

Eligibility

Sex

ALL

Min age

20 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age ≥20 years 2. All comers who underwent successful FFR measurement and pullback tracing Exclusion Criteria: 1. Chronic renal failure (estimated glomerular filtration rate \<30) 2. ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery history 3. Primary myocardial or valvular disease 4. Left ventricular ejection fraction \< 30% 5. Hemodynamically unstable clinical conditions 6. Life expectancy \< 2 years

Primary outcome measure(s)

Adverse cardiovascular event according to ΔFFR (Deferral of PCI group) — Upto 2 years after index procedure
Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death
Adverse cardiovascular event according to post-PCI FFR (PCI group) — Upto 2 years after index procedure
Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death

Trial sites (1)

Facility	City	Region	Status
Seoul National University Hospital	Seoul	South Korea	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05250557 on ClinicalTrials.gov ↗ ← All trials in South Korea