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NCT Number: NCT05250557

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥20 years
  • All comers who underwent successful FFR measurement and pullback tracing

Exclusion criteria

  • Chronic renal failure (estimated glomerular filtration rate <30)
  • ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery history
  • Primary myocardial or valvular disease
  • Left ventricular ejection fraction < 30%
  • Hemodynamically unstable clinical conditions
  • Life expectancy < 2 years

Treatment and study plan

Fractional flow reserve

Diagnostic Test

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).

Primary outcomes

  1. Adverse cardiovascular event according to ΔFFR (Deferral of PCI group)

    Time frame: Upto 2 years after index procedure

    Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death

  2. Adverse cardiovascular event according to post-PCI FFR (PCI group)

    Time frame: Upto 2 years after index procedure

    Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death

Study contacts

Contact information is provided by the study sponsor or research team.

Bon-Kwon Koo, MD, PhD

CONTACT

[email protected]

+82-2-2072-2062

Seokhun Yang, MD

CONTACT

[email protected]

+82-2-2072-2062

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Dong-A University Hospital
  • Gyeongsang National University Hospital
  • Inje University
  • KangWon National University Hospital
  • Keimyung University Dongsan Medical Center
  • Seoul National University Bundang Hospital
  • Severance Hospital
  • Tsuchiura Kyodo General Hospital
  • Ulsan University Hospital
  • Wonju Severance Christian Hospital

Registry information

Official study title

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

Acronym: PRIME-FFR

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Feb 22, 2022
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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