Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease
FATE-MAIN
A Comparison of Fractional Flow Reserve- Versus Angiography-Guided Percutaneous Coronary Intervention in Patients With Left Main Coronary Artery Disease
1 other identifier
interventional
960
5 countries
48
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2023
CompletedFirst Posted
Study publicly available on registry
April 26, 2023
CompletedStudy Start
First participant enrolled
April 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
December 29, 2025
December 1, 2025
3.1 years
March 30, 2023
December 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The composite event rate
Composite event consists of death from any causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, or repeat revascularization. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.
2 years
Secondary Outcomes (16)
The event rate of death from any causes
2 years
The event rate of myocardial infarction
2 years
The event rate of hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest
2 years
The event rate of repeat revascularization
2 years
The composite event rate of death or myocardial infarction
2 years
- +11 more secondary outcomes
Study Arms (2)
FFR-guided Left Main PCI
EXPERIMENTALAngiography-Guided PCI
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
- Severe left ventricular dysfunction (ejection fraction \<30%).
- Requirement for other cardiac surgical procedure (e.g., valve replacement or aorta surgery).
- 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.
- Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
- End-stage renal disease requiring renal replacement therapy.
- Liver cirrhosis.
- Pregnant and/or lactating women.
- Concurrent medical condition with a limited life expectancy of less than 2 years.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (48)
Princess Margret Hospital( HongKong)
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Manipal Hospital
Bangalore, India
Japanese Red Cross Musashino Hospital
Tokyo, Japan
NTT East Japan Kanto Hospital
Tokyo, Japan
Tsuchiura Kyodo General Hospital
Tsuchiura, Japan
Asan Medical Center
Seoul, Songpa-gu, 138-736, South Korea
Korea University Ansan Hospital
Ansan, South Korea
Hallym University Sacred Heart Hospital
Anyang, South Korea
Bucheon Sejong Hospital
Bucheon-si, South Korea
Dong-A University Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Pusan National University Yangsan Hospital
Busan, South Korea
Changwon Gyeongsang National University Hospital
Changwon, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Yeungnam University Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Daejeon St. Mary's Hospital, Catholic University of Korea
Daejeon, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, South Korea
CHA Ilsan Medical Center
Ilsan, South Korea
Ilsan Myongji Hospital
Ilsan, South Korea
Inje University Ilsan Paik Hospital
Ilsan, South Korea
National Health Insurance Service Ilsan Hospital
Ilsan, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Jeju National University Hospital
Jeju City, South Korea
Chungnam National University Sejong Hospital
Seongam, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Eunpyeong St. Mary's Hospital, Catholic University of Korea
Seoul, South Korea
Hanyang University Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyung Hee University Hospital
Seoul, South Korea
Seoul Metropolitan Boramae Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Soonchunhyang University Seoul Hospital
Seoul, South Korea
Yeouido St. Mary's Hospital, Catholic University of Korea
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
St. Vincent's Hospital, Catholic University of Korea
Suwon, South Korea
Ulsan University Hospital
Ulsan, South Korea
Yongin Severance Hospital
Yŏngin, South Korea
Cheng Hsin General Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Duk-woo Park, MD
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Cardiology, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center
Study Record Dates
First Submitted
March 30, 2023
First Posted
April 26, 2023
Study Start
April 25, 2024
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
December 29, 2025
Record last verified: 2025-12