Seoul National University Hospital
Seoul, 110-744, South Korea
Location status: Recruiting
Location contact
Bon-Kwon Koo, MD, PhD
CONTACT
Seokhun Yang, MD
CONTACT
NCT Number: NCT05250557
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.
Interested in participating?
Request Info20 year and older
All sexes
Observational
Seoul, 110-744, South Korea
Location status: Recruiting
Bon-Kwon Koo, MD, PhD
CONTACT
Seokhun Yang, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Upto 2 years after index procedure
Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death
Time frame: Upto 2 years after index procedure
Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death
Contact information is provided by the study sponsor or research team.
Bon-Kwon Koo, MD, PhD
CONTACT
Seokhun Yang, MD
CONTACT
Seoul National University Hospital
Other
Prognostic Impact of Lesion-specific Hemodynamic Index and Disease Characteristics in Patients With Coronary Artery Disease Assessed by Fractional Flow Reserve
Acronym: PRIME-FFR
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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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