Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorSeung-Jung Park

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

left anterior descending coronary artery (LAD) or left circumflex coronary artery (LCx) chronic total occlusion (CTO)

Extremely calcified or tortuous vessels precluding FFR measurement.

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).

Recent ST Elevation Myocardial Infarction(<7 days prior to randomization).

Trial design

Treatments tested in this trial

  • FFR-Guided PCI
  • Angiography-Guided PCI

Treatment groups

960 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Seung-Jung Park

Lead sponsor

Asan Medical Center

Sponsor institution

CardioVascular Research Foundation, Korea

Collaborator