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Active, not recruiting Observational

INsTantenous wavE-Free Ratio-guided PCI Versus Fractional Flow REserve-Guided PCI in rouTine Clinical Practice, Prospective, Multicenter Registry

NCT03338309 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2017-11-01
Last updated
2025-03-14

Condition(s) studied

Stable AnginaNon ST Segment Elevation Myocardial InfarctionST-segment Elevation Myocardial InfarctionSilent Myocardial IschemiaUnstable Angina

Investigational drug(s) / intervention(s)

Instantaneous wave-free ratio measurement

Instantaneous wave-free ratio measurement: Instantaneous wave-free ratio measurement in order to evaluate functional significance of epicardial stenosis

Study summary

The current study sought to evaluate the clinical relevance of iFR-guided strategy in real world clinical practice using unrestricted study population from stable angina to acute coronary syndrome including acute ST-segment elevation myocardial infarction. Previous abundant historical data of FFR-guided strategy will be also included as historical control to validate the iFR-guided strategy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Subject must be ≥18 years * Patients suspected with ischemic heart disease ③ Patients with coronary artery stenosis with intermediate degree of stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery amenable to stent implantation or vessel size≥2.5 mm without definitive previous evidence of myocardial ischemia. * Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides Exclusion Criteria: * Cardiogenic shock (systolic blood pressure \< 90mmHg or requiring inotropics to maintain blood pressure \> 90mmHg) * Patients with a known hypersensitivity or contraindication to any of the following medications: statin, ezetimibe, heparin, aspirin, clopidogrel, prasugrel, ticagrelor ③ Non-cardiac co-morbid conditions are present with life expectancy \<2 year (per site investigator's medical judgment). * History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia) * Patients with active pathologic bleeding ⑥ Gastrointestinal or genitourinary major bleeding within the prior 3 months. ⑦ Target lesion located in coronary arterial bypass graft

Primary outcome measure(s)

  • Patient-oriented composite outcome (POCO) — at 2-year after index procedure
    a composite of any death, any myocardial infarction (MI) or any revascularization according to the ARC consensus

Trial sites (4)

FacilityCityRegionStatus
Keimyung University Dongsan Medical Center Daegu South Korea
Inje University Ilsan Paik Hospital Goyang South Korea
Samsung Medical Center Seoul South Korea
Seoul National University Hospital Seoul South Korea
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 NCT03338309 on ClinicalTrials.gov ↗ ← All trials in South Korea