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

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).

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Coronary Artery Disease Left Main
• Intervention / Treatment: Procedure: FFR-Guided PCI; Procedure: Angiography-Guided PCI

Detailed Description

All participants will be monitored over a span of two years and the time point of the year of last subject last visit. The term "year of last subject last visit" refers to the time point of the last visit for all participants. At this specific time point, event occurrence check will be conducted to determine the occurrence of endpoint events among all participants.

• Study Type: Interventional
• Enrollment (Estimated): 960
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Duk-woo Park, MD; Email: dwpark@amc.seoul.kr

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Not yet recruiting
    • Queen Mary Hospital
    • Contact: Chi Simon Lam Cheung, MD
    • Principal Investigator: Chi Simon Lam Cheung, MD
  • Hong Kong, Hong Kong
    • Not yet recruiting
    • Princess Margret Hospital( HongKong)
    • Contact: Raymond Fung, MD
    • Principal Investigator: Raymond Fung, MD
• India
  • Bangalore, India
    • Recruiting
    • Manipal Hospital
    • Contact: Singh Chadha Davinder, MD
    • Principal Investigator: Singh Chadha Davinder, MD
• Japan
  • Tokyo, Japan
    • Not yet recruiting
    • Japanese Red Cross Musashino Hospital
    • Contact: Ashikaga Takashi, MD
    • Principal Investigator: Ashikaga Takashi, MD
  • Tokyo, Japan
    • Not yet recruiting
    • NTT East Japan Kanto Hospital
    • Contact: Warisawa Takayuki, MD
    • Principal Investigator: Warisawa Takayuki, MD
  • Tsuchiura, Japan
    • Recruiting
    • Tsuchiura Kyodo General Hospital
    • Contact: Kakuta Tsunekazu, MD
    • Principal Investigator: Kakuta Tsunekazu, MD
• South Korea
  • Ansan, South Korea
    • Not yet recruiting
    • Korea University Ansan Hospital
    • Contact: Sun Won Kim, MD
    • Principal Investigator: Sun Won Kim, MD
  • Anyang, South Korea
    • Recruiting
    • Hallym University Sacred Heart Hospital
    • Contact: Sang Ho Cho, MD
    • Principal Investigator: Sang Ho Cho, MD
  • Bucheon-si, South Korea
    • Recruiting
    • Bucheon Sejong Hospital
    • Contact: Ho-yeon Kim, MD
    • Principal Investigator: Ho-yeon Kim, MD
  • Busan, South Korea
    • Recruiting
    • Pusan National University Hospital
    • Contact: Jung Chun Choi, MD
    • Principal Investigator: Jung Chun Choi, MD
  • Busan, South Korea
    • Recruiting
    • Dong-A University Hospital
    • Contact: Yong Lak Cho, MD
    • Principal Investigator: Yong Lak Cho, MD
  • Busan, South Korea
    • Not yet recruiting
    • Pusan National University Yangsan Hospital
    • Contact: Guk Jin Chun, MD
    • Principal Investigator: Guk Jin Chun, MD
  • Changwon, South Korea
    • Recruiting
    • Changwon Gyeongsang National University Hospital
    • Principal Investigator: Jae Seok Bae, MD
    • Contact: Jae Seok Bae, MD
  • Chuncheon, South Korea
    • Recruiting
    • Kangwon National University Hospital
    • Contact: Bong Ki Lee, MD
    • Principal Investigator: Bong Ki Lee, MD
  • Daegu, South Korea
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Principal Investigator: Chang Wook Nam, MD
    • Contact: Chang Wook Nam, MD
  • Daegu, South Korea
    • Recruiting
    • Yeungnam University Hospital
    • Principal Investigator: Woong Kim, MD
    • Contact: Woong Kim, MD
  • Daegu, South Korea
    • Recruiting
    • Daegu Catholic University Medical Center
    • Contact: Jin Bae Lee, MD
    • Principal Investigator: Jin Bae Lee, MD
  • Daejeon, South Korea
    • Recruiting
    • Chungnam National University Hospital
    • Contact: Pil Sang Song, MD
    • Principal Investigator: Pil Sang Song, MD
  • Daejeon, South Korea
    • Recruiting
    • Daejeon St. Mary's Hospital, Catholic University of Korea
    • Contact: Kyu Seob Lee, MD
    • Principal Investigator: Kyu Seob Lee, MD
  • Gangneung, South Korea
    • Recruiting
    • GangNeung Asan Hospital
    • Contact: Han Bit Park, MD
    • Principal Investigator: Han Bit Park, MD
  • Gwangju, South Korea
    • Recruiting
    • Chonnam National University Hospital
    • Contact: Young Joon Hong
    • Principal Investigator: Young Joon Hong
  • Gwangmyeong, South Korea
    • Recruiting
    • Chung-Ang University Gwangmyeong Hospital
    • Contact: Young Hoon Jung, MD
    • Principal Investigator: Young Hoon Jung, MD
  • Hwaseong-si, South Korea
    • Recruiting
    • Hallym University Dongtan Sacred Heart Hospital
    • Contact: Jin Hwa Lee, MD
    • Principal Investigator: Jin Hwa Lee, MD
  • Ilsan, South Korea
    • Recruiting
    • National Health Insurance Service Ilsan Hospital
    • Contact: Ji Yong Jang, MD
    • Principal Investigator: Ji Yong Jang, MD
  • Ilsan, South Korea
    • Not yet recruiting
    • Cha Ilsan Medical Center
    • Contact: Won Jang Kim, MD
    • Principal Investigator: Won Jang Kim, MD
  • Ilsan, South Korea
    • Not yet recruiting
    • Ilsan Myongji Hospital
    • Contact: Yoon Hyung Cho, MD
    • Principal Investigator: Yoon Hyung Cho, MD
  • Ilsan, South Korea
    • Not yet recruiting
    • Inje University Ilsan Paik Hospital
    • Contact: Joon Hyung Do, MD
    • Principal Investigator: Joon Hyung Do, MD
  • Incheon, South Korea
    • Recruiting
    • Inha University Hospital
    • Contact: Sang Don Park, MD
    • Principal Investigator: Sang Don Park, MD
  • Incheon, South Korea
    • Recruiting
    • Gachon University Gil Medical Center
    • Principal Investigator: Seung Hwan Han, MD
    • Contact: Seung Hwan Han, MD
  • Jeju City, South Korea
    • Not yet recruiting
    • Jeju National University Hospital
    • Contact: Song Yi Kim, MD
    • Principal Investigator: Song Yi Kim, MD
  • Seongam, South Korea
    • Recruiting
    • Chungnam National University Sejong Hospital
    • Contact: Won Mook Hwang, MD
    • Principal Investigator: Won Mook Hwang, MD
  • Seongnam, South Korea
    • Recruiting
    • Seoul National University Bundang Hospital
    • Contact: In Ho Chae, MD
    • Principal Investigator: In Ho Chae, MD
  • Seoul, South Korea
    • Recruiting
    • Chung-Ang University Hospital
    • Contact: Ho Yeon Won, MD
    • Principal Investigator: Ho Yeon Won, MD
  • Seoul, South Korea
    • Recruiting
    • Seoul National University Hospital
    • Contact: Bon Kwon Koo, MD
    • Principal Investigator: Bon Kwon Koo, MD
  • Seoul, South Korea
    • Recruiting
    • Korea University Guro Hospital
    • Contact: Dong Ho Kang, MD
    • Principal Investigator: Dong Ho Kang, MD
  • Seoul, South Korea
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Hyung Joon Joo, MD
    • Principal Investigator: Hyung Joon Joo, MD
  • Seoul, South Korea
    • Recruiting
    • Soonchunhyang University Seoul Hospital
    • Contact: Deok Won Bang, MD
    • Principal Investigator: Deok Won Bang, MD
  • Seoul, South Korea
    • Recruiting
    • Kyung Hee University Hospital
    • Contact: Won Kim, MD
    • Principal Investigator: Won Kim, MD
  • Seoul, South Korea
    • Recruiting
    • Eunpyeong St. Mary's Hospital, Catholic University of Korea
    • Contact: Jung Hoon Lee, MD
    • Principal Investigator: Jung Hoon Lee, MD
  • Seoul, South Korea
    • Recruiting
    • Hanyang University Hospital
    • Contact: Young Hyo Lim, MD
    • Principal Investigator: Young Hyo Lim, MD
  • Seoul, South Korea
    • Recruiting
    • Seoul Metropolitan Boramae Hospital
    • Contact: Woo Young Jung, MD
    • Principal Investigator: Woo Young Jung, MD
  • Seoul, South Korea
    • Recruiting
    • Yeouido St. Mary's Hospital, Catholic University of Korea
    • Contact: Chul Soo Park, MD
    • Principal Investigator: Chul Soo Park, MD
  • Suwon, South Korea
    • Recruiting
    • Ajou University Hospital
    • Contact: Myoung Ho Yoon, MD
    • Principal Investigator: Myoung Ho Yoon, MD
  • Suwon, South Korea
    • Recruiting
    • St. Vincent's Hospital, Catholic University of Korea
    • Contact: Sung Ho Heo, MD
    • Principal Investigator: Sung Ho Heo, MD
  • Ulsan, South Korea
    • Recruiting
    • Ulsan University Hospital
    • Contact: Kyung Min Park, MD
    • Principal Investigator: Kyung Min Park, MD
  • Yŏngin, South Korea
    • Recruiting
    • Yongin Severance Hospital
    • Contact: Yong Chul Kim, MD
    • Principal Investigator: Yong Chul Kim, MD
  • Songpa-gu
    • Seoul, Songpa-gu, South Korea, 138-736
      • Recruiting
      • Asan Medical Center
      • Contact: Seung-jung Park, MD, PhD
      • Principal Investigator: Seung-jung Park, MD, PhD
• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Cheng Hsin General Hospital
    • Contact: Wei-Hsian Yin, MD
    • Principal Investigator: Wei-Hsian Yin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
2. 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.
3. 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 Criteria:

1. left anterior descending coronary artery (LAD) or left circumflex coronary artery (LCx) chronic total occlusion (CTO)
2. Extremely calcified or tortuous vessels precluding FFR measurement.
3. 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).
4. Recent ST Elevation Myocardial Infarction(<7 days prior to randomization).
5. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
6. Severe left ventricular dysfunction (ejection fraction <30%).
7. Requirement for other cardiac surgical procedure (e.g., valve replacement or aorta surgery).
8. Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel).
9. Prior PCI of the left main trunk.
10. Prior coronary artery bypass graft surgery.
11. Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
12. End-stage renal disease requiring renal replacement therapy.
13. Liver cirrhosis.
14. Pregnant and/or lactating women.
15. Concurrent medical condition with a limited life expectancy of less than 2 years.
16. 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;

1) Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial.

2) Screening failed before any interventional factor is involved.

3) 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FFR-guided Left Main PCI	Procedure: FFR-Guided PCI; Fractional Flow Reserve-Guided PCI
Active Comparator: Angiography-Guided PCI	Procedure: Angiography-Guided PCI; Angiography-Guided PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The event rate of stroke		2 years
Procedure time		1 day
Amount of contrast agent used		1 day
Length of hospital stay		an average of 7 day
The event rate of death from any causes		2 years
The event rate of myocardial infarction	any, spontaneous or procedural 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
The event rate of stent thrombosis	Stent thrombosis by Academic Research Consortium (ARC) definition	2 years
The event rate of bleeding complications	Bleeding Academic Research Consortium [BARC] type 3-5, which indicates severe bleeding	2 years
The event rate of rehospitalization	Rehospitalization from any, cardiac, or noncardiac causes	2 years
Functional class	Functional class assessed by the Canadian Cardiovascular Society (CCS) Angina Score classification. The minimum and maximum values are I and IV respectively and a higher score means a worse outcome.	7 days(discharge) and 1, 6, 12, 24 months
Change of angina-related quality of life index	By the Seattle Angina Questionnaire [SAQ]. the SAQ is a disease-specific patient-reported outcome (PRO) with 5 domains. Lower score represents poor health status and high score represents good health status.	7 days(discharge) and 1, 6, 12, 24 months
Change of health-related quality of life index	By the EQ-5D. EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group. Range 0 - 1 and a higher score of EQ-5D mean low quality of life.	7 days(discharge) and 1, 6, 12, 24 months
Number of anti-anginal medications		7 days(discharge) and 1, 6, 12, 24 months

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea
• Investigators: Principal Investigator: Duk-woo Park, MD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Fractional Flow Reserve
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: AMCCV2023-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No