Compares two ways of guiding stent treatment in left main coronary artery disease
Compares fractional flow reserve-guided and angiography-guided stenting in adults with left main heart artery disease.
Plain-language title generated from the registry record
Registry title: Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease
Key facts
- Where
- Tokyo and Tsuchiura, JapanSee the 3 sites
Where in Japan
- Japanese Red Cross Musashino HospitalTokyo, JapanTaking people
- NTT East Japan Kanto HospitalTokyo, JapanNo longer taking part
- Tsuchiura Kyodo General HospitalTsuchiura, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Seung-Jung Park
- Trial code
- NCT05829889
- Record updated
- 24 June 2026
- Original description
The primary purpose of the study was to determine whether the 2-year probability of major adverse cardiac events (primary composite outcome) differed significantly between patients who underwent angiography-guided Percutaneous Coronary Intervention(PCI) and those who underwent Fractional Flow Reserve(FFR)-guided PCI in patients with Left Main Coronary Artery disease(LMCA).Read full original descriptionShow less
A Comparison of Fractional Flow Reserve- Versus Angiography-Guided Percutaneous Coronary Intervention in Patients With Left Main Coronary Artery Disease
The primary purpose of the study was to determine whether the 2-year probability of major adverse cardiac events (primary composite outcome) differed significantly between patients who underwent angiography-guided Percutaneous Coronary Intervention(PCI) and those who underwent Fractional Flow Reserve(FFR)-guided PCI in patients with Left Main Coronary Artery disease(LMCA).
Inclusion: The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia; Significant de novo LMCA disease, defined as ≥ 50% diameter stenosis by visual estimation with or without concomitant non-left main major epicardial coronary artery disease, amenable to PCI with drug-eluting stent(DES) implantation; The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion: Recent ST Elevation Myocardial Infarction(<7 days prior to randomization); Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel); Prior PCI of the left main trunk; Prior coronary artery bypass graft surgery; Concurrent medical condition with a limited life expectancy of less than 2 years; Participated in academic trials like strategic comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies; The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with coronary artery bypass graft or medical therapy alone); Requirement for other cardiac surgical procedure (e.g., valve replacement or aorta surgery); Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year; End-stage renal disease requiring renal replacement therapy; Subjects who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion; Severe left ventricular dysfunction (ejection fraction <30%); left anterior descending coronary artery (LAD) or left circumflex coronary artery (LCx) chronic total occlusion (CTO); Extremely calcified or tortuous vessels precluding FFR measurement; Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support; Liver cirrhosis; Pregnant and/or lactating women; Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial; Screening failed before any interventional factor is involved.