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RecruitingNCT05829889FATE-MAINUpdated Jun 24, 2026

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

An interventional study of FFR-Guided PCI and Angiography-Guided PCI in Coronary Artery Disease Left Main and Coronary Artery Disease, sponsored by Seung-Jung Park. Recruiting at 49 sites in 5 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Seung-Jung Park · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
960
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Coronary Artery Disease Left Main
  • Coronary Artery Disease

Keywords

  • Fractional Flow Reserve
  • Percutaneous Coronary Intervention
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
960 participants (estimated)

Study arms

  • Experimental
    FFR-guided Left Main PCI

    Procedure: FFR-Guided PCI

  • Active comparator
    Angiography-Guided PCI

    Procedure: Angiography-Guided PCI

Interventions

  • ProcedureFFR-Guided PCI

    Fractional Flow Reserve-Guided PCI

  • ProcedureAngiography-Guided PCI

    Angiography-Guided PCI

05

What researchers measure

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.

    Time frame: 2 years

Secondary outcomes

  1. The event rate of death from any causes

    Time frame: 2 years

  2. The event rate of myocardial infarction

    any, spontaneous or procedural myocardial infarction

    Time frame: 2 years

  3. The event rate of hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest

    Time frame: 2 years

  4. The event rate of repeat revascularization

    Time frame: 2 years

  5. The composite event rate of death or myocardial infarction

    Time frame: 2 years

  6. The event rate of stent thrombosis

    Stent thrombosis by Academic Research Consortium (ARC) definition

    Time frame: 2 years

  7. The event rate of stroke

    Time frame: 2 years

  8. The event rate of bleeding complications

    Bleeding Academic Research Consortium \[BARC\] type 3-5, which indicates severe bleeding

    Time frame: 2 years

  9. Procedure time

    Time frame: 1 day

  10. Amount of contrast agent used

    Time frame: 1 day

  11. Length of hospital stay

    Time frame: an average of 7 day

  12. The event rate of rehospitalization

    Rehospitalization from any, cardiac, or noncardiac causes

    Time frame: 2 years

  13. 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.

    Time frame: 7 days(discharge) and 1, 6, 12, 24 months

  14. 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.

    Time frame: 7 days(discharge) and 1, 6, 12, 24 months

  15. 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.

    Time frame: 7 days(discharge) and 1, 6, 12, 24 months

  16. Number of anti-anginal medications

    Time frame: 7 days(discharge) and 1, 6, 12, 24 months

06

Study locations

38 of 49 sites recruiting
  • Princess Margret Hospital( HongKong)
    Hong Kong, Hong Kong
    • Raymond Fung, MD · Contact
    • Raymond Fung, MD · Principal investigator
    Not yet recruiting
  • Queen Mary Hospital
    Hong Kong, Hong Kong
    • Chi Simon Lam Cheung, MD · Contact
    • Chi Simon Lam Cheung, MD · Principal investigator
    Not yet recruiting
  • Manipal Hospital
    Bangalore, India
    • Singh Chadha Davinder, MD · Contact
    • Singh Chadha Davinder, MD · Principal investigator
    Recruiting
  • Japanese Red Cross Musashino Hospital
    Tokyo, Japan
    • Ashikaga Takashi, MD · Contact
    • Ashikaga Takashi, MD · Principal investigator
    Recruiting
  • NTT East Japan Kanto Hospital
    Tokyo, Japan
    Withdrawn
  • Tsuchiura Kyodo General Hospital
    Tsuchiura, Japan
    • Kakuta Tsunekazu, MD · Contact
    • Kakuta Tsunekazu, MD · Principal investigator
    Recruiting
  • Asan Medical Center
    Seoul, Songpa-gu 138-736, South Korea
    • Seung-jung Park, MD, PhD · Contact
    • Seung-jung Park, MD, PhD · Principal investigator
    Recruiting
  • Korea University Ansan Hospital
    Ansan, South Korea
    Terminated
  • Hallym University Sacred Heart Hospital
    Anyang, South Korea
    • Sang Ho Cho, MD · Contact
    • Sang Ho Cho, MD · Principal investigator
    Recruiting
  • Bucheon Sejong Hospital
    Bucheon-si, South Korea
    • Ho-yeon Kim, MD · Contact
    • Ho-yeon Kim, MD · Principal investigator
    Recruiting
  • Dong-A University Hospital
    Busan, South Korea
    • Yong Lak Cho, MD · Contact
    • Yong Lak Cho, MD · Principal investigator
    Recruiting
  • Pusan National University Hospital
    Busan, South Korea
    • Jung Chun Choi, MD · Contact
    • Jung Chun Choi, MD · Principal investigator
    Recruiting
  • Pusan National University Yangsan Hospital
    Busan, South Korea
    Terminated
  • Changwon Gyeongsang National University Hospital
    Changwon, South Korea
    • Jae Seok Bae, MD · Contact
    • Jae Seok Bae, MD · Principal investigator
    Recruiting
  • Kangwon National University Hospital
    Chuncheon, South Korea
    • Bong Ki Lee, MD · Contact
    • Bong Ki Lee, MD · Principal investigator
    Recruiting
  • Daegu Catholic University Medical Center
    Daegu, South Korea
    • Jin Bae Lee, MD · Contact
    • Jin Bae Lee, MD · Principal investigator
    Recruiting
  • Keimyung University Dongsan Medical Center
    Daegu, South Korea
    • Chang Wook Nam, MD · Contact
    • Chang Wook Nam, MD · Principal investigator
    Recruiting
  • Yeungnam University Hospital
    Daegu, South Korea
    • Woong Kim, MD · Contact
    • Woong Kim, MD · Principal investigator
    Recruiting
  • Chungnam National University Hospital
    Daejeon, South Korea
    • Jae Hwan Lee, MD · Contact
    • Jae Hwan Lee, MD · Principal investigator
    Recruiting
  • Daejeon St. Mary's Hospital, Catholic University of Korea
    Daejeon, South Korea
    • Kyu Seob Lee, MD · Contact
    • Kyu Seob Lee, MD · Principal investigator
    Recruiting
  • Gangneung Asan Hospital
    Gangneung, South Korea
    • Han Bit Park, MD · Contact
    • Han Bit Park, MD · Principal investigator
    Recruiting
  • Chonnam National University Hospital
    Gwangju, South Korea
    • Young Joon Hong · Contact
    • Young Joon Hong · Principal investigator
    Recruiting
  • Chung-Ang University Gwangmyeong Hospital
    Gwangmyeong, South Korea
    • Young Hoon Jung, MD · Contact
    • Young Hoon Jung, MD · Principal investigator
    Recruiting
  • Hallym University Dongtan Sacred Heart Hospital
    Hwaseong-si, South Korea
    • Jin Hwa Lee, MD · Contact
    • Jin Hwa Lee, MD · Principal investigator
    Recruiting
  • CHA Ilsan Medical Center
    Ilsan, South Korea
    Terminated
  • Ilsan Myongji Hospital
    Ilsan, South Korea
    Terminated
  • Inje University Ilsan Paik Hospital
    Ilsan, South Korea
    • Joon Hyung Do, MD · Contact
    • Joon Hyung Do, MD · Principal investigator
    Not yet recruiting
  • National Health Insurance Service Ilsan Hospital
    Ilsan, South Korea
    • Ji Yong Jang, MD · Contact
    • Ji Yong Jang, MD · Principal investigator
    Recruiting
  • Gachon University Gil Medical Center
    Incheon, South Korea
    • Seung Hwan Han, MD · Contact
    • Seung Hwan Han, MD · Principal investigator
    Recruiting
  • Inha University Hospital
    Incheon, South Korea
    • Sang Don Park, MD · Contact
    • Sang Don Park, MD · Principal investigator
    Recruiting
  • Jeju National University Hospital
    Jeju City, South Korea
    Terminated
  • Chungnam National University Sejong Hospital
    Seongam, South Korea
    • Won Mook Hwang, MD · Contact
    • Won Mook Hwang, MD · Principal investigator
    Recruiting
  • Seoul National University Bundang Hospital
    Seongnam, South Korea
    • In Ho Chae, MD · Contact
    • In Ho Chae, MD · Principal investigator
    Recruiting
  • Chung-Ang University Hospital
    Seoul, South Korea
    • Ho Yeon Won, MD · Contact
    • Ho Yeon Won, MD · Principal investigator
    Recruiting
  • Eunpyeong St. Mary's Hospital, Catholic University of Korea
    Seoul, South Korea
    • Oh Sung Kwon, MD · Contact
    • Oh Sung Kwon, MD · Principal investigator
    Recruiting
  • Hanyang University Hospital
    Seoul, South Korea
    • Young Hyo Lim, MD · Contact
    • Young Hyo Lim, MD · Principal investigator
    Recruiting
  • Kangbuk Samsung Hospital
    Seoul, South Korea
    • Seung Jae Lee, MD · Contact
    • Seung Jae Lee, MD · Principal investigator
    Not yet recruiting
  • Korea University Anam Hospital
    Seoul, South Korea
    Terminated
  • Korea University Guro Hospital
    Seoul, South Korea
    • Dong Ho Kang, MD · Contact
    • Dong Ho Kang, MD · Principal investigator
    Recruiting
  • Kyung Hee University Hospital
    Seoul, South Korea
    • Won Kim, MD · Contact
    • Won Kim, MD · Principal investigator
    Recruiting
  • Seoul Metropolitan Boramae Hospital
    Seoul, South Korea
    • Woo Young Jung, MD · Contact
    • Woo Young Jung, MD · Principal investigator
    Recruiting
  • Seoul National University Hospital
    Seoul, South Korea
    • Bon Kwon Koo, MD · Contact
    • Bon Kwon Koo, MD · Principal investigator
    Recruiting
  • Soonchunhyang University Seoul Hospital
    Seoul, South Korea
    • Deok Won Bang, MD · Contact
    • Deok Won Bang, MD · Principal investigator
    Recruiting
  • Yeouido St. Mary's Hospital, Catholic University of Korea
    Seoul, South Korea
    • Chul Soo Park, MD · Contact
    • Chul Soo Park, MD · Principal investigator
    Recruiting
  • Ajou University Hospital
    Suwon, South Korea
    • Myoung Ho Yoon, MD · Contact
    • Myoung Ho Yoon, MD · Principal investigator
    Recruiting
  • St. Vincent's Hospital, Catholic University of Korea
    Suwon, South Korea
    • Sung Ho Heo, MD · Contact
    • Sung Ho Heo, MD · Principal investigator
    Recruiting
  • Ulsan University Hospital
    Ulsan, South Korea
    • Kyung Min Park, MD · Contact
    • Kyung Min Park, MD · Principal investigator
    Recruiting
  • Yongin Severance Hospital
    Yongin, South Korea
    • Yong Chul Kim, MD · Contact
    • Yong Chul Kim, MD · Principal investigator
    Recruiting
  • Cheng Hsin General Hospital
    Taipei, Taiwan
    • Wei-Hsian Yin, MD · Contact
    • Wei-Hsian Yin, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05829889
Lead sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Seung-Jung Park (Professor, Cardiology, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center, Asan Medical Center) — Sponsor-investigator
First posted
Apr 26, 2023
Start date
Apr 25, 2024
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 24, 2026

Study contacts

Duk-woo Park, MD
Contact
dwpark@amc.seoul.kr
Duk-woo Park, MD
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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