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Coronary Artery Disease Left MainFATE-MAINNCT05829889

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

A study testing FFR-Guided PCI and Angiography-Guided PCI in people with Coronary Artery Disease Left Main and Coronary Artery Disease, run by Seung-Jung Park at 49 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
FFR-Guided PCI and Angiography-Guided PCI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
960 participants
Where
49 sitesin 5 countries
Study dates
25 Apr 2024to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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%).
Show all 19Show fewer
  • 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.
  • 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.

Trial locations and contacts

49 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Duk-woo Park, MD contact

dwpark@amc.seoul.kr

49 sites in 5 countries

South Korea42 sites, 36 recruiting

  • Korea University Ansan Hospital

    Ansan

    Terminated

  • Hallym University Sacred Heart Hospital

    Anyang

    Sang Ho Cho, MD

    Sang Ho Cho, MD

    Recruiting

  • Bucheon Sejong Hospital

    Bucheon-si

    Ho-yeon Kim, MD

    Ho-yeon Kim, MD

    Recruiting

  • Dong-A University Hospital

    Busan

    Yong Lak Cho, MD

    Yong Lak Cho, MD

    Recruiting

  • Pusan National University Hospital

    Busan

    Jung Chun Choi, MD

    Jung Chun Choi, MD

    Recruiting

  • Pusan National University Yangsan Hospital

    Busan

    Terminated

  • Changwon Gyeongsang National University Hospital

    Changwon

    Jae Seok Bae, MD

    Jae Seok Bae, MD

    Recruiting

  • Kangwon National University Hospital

    Chuncheon

    Bong Ki Lee, MD

    Bong Ki Lee, MD

    Recruiting

  • Daegu Catholic University Medical Center

    Daegu

    Jin Bae Lee, MD

    Jin Bae Lee, MD

    Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Chang Wook Nam, MD

    Chang Wook Nam, MD

    Recruiting

  • Yeungnam University Hospital

    Daegu

    Woong Kim, MD

    Woong Kim, MD

    Recruiting

  • Chungnam National University Hospital

    Daejeon

    Jae Hwan Lee, MD

    Jae Hwan Lee, MD

    Recruiting

  • Daejeon St. Mary's Hospital, Catholic University of Korea

    Daejeon

    Kyu Seob Lee, MD

    Kyu Seob Lee, MD

    Recruiting

  • Gangneung Asan Hospital

    Gangneung

    Han Bit Park, MD

    Han Bit Park, MD

    Recruiting

  • Chonnam National University Hospital

    Gwangju

    Young Joon Hong

    Young Joon Hong

    Recruiting

  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong

    Young Hoon Jung, MD

    Young Hoon Jung, MD

    Recruiting

  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si

    Jin Hwa Lee, MD

    Jin Hwa Lee, MD

    Recruiting

  • CHA Ilsan Medical Center

    Ilsan

    Terminated

  • Ilsan Myongji Hospital

    Ilsan

    Terminated

  • Inje University Ilsan Paik Hospital

    Ilsan

    Joon Hyung Do, MD

    Joon Hyung Do, MD

    Not yet recruiting

  • National Health Insurance Service Ilsan Hospital

    Ilsan

    Ji Yong Jang, MD

    Ji Yong Jang, MD

    Recruiting

  • Gachon University Gil Medical Center

    Incheon

    Seung Hwan Han, MD

    Seung Hwan Han, MD

    Recruiting

  • Inha University Hospital

    Incheon

    Sang Don Park, MD

    Sang Don Park, MD

    Recruiting

  • Jeju National University Hospital

    Jeju City

    Terminated

  • Chungnam National University Sejong Hospital

    Seongam

    Won Mook Hwang, MD

    Won Mook Hwang, MD

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam

    In Ho Chae, MD

    In Ho Chae, MD

    Recruiting

  • Asan Medical Center

    Seoul, Songpa-gu, 138-736

    Seung-jung Park, MD, PhD

    Seung-jung Park, MD, PhD

    Recruiting

  • Chung-Ang University Hospital

    Seoul

    Ho Yeon Won, MD

    Ho Yeon Won, MD

    Recruiting

  • Eunpyeong St. Mary's Hospital, Catholic University of Korea

    Seoul

    Oh Sung Kwon, MD

    Oh Sung Kwon, MD

    Recruiting

  • Hanyang University Hospital

    Seoul

    Young Hyo Lim, MD

    Young Hyo Lim, MD

    Recruiting

  • Kangbuk Samsung Hospital

    Seoul

    Seung Jae Lee, MD

    Seung Jae Lee, MD

    Not yet recruiting

  • Korea University Anam Hospital

    Seoul

    Terminated

  • Korea University Guro Hospital

    Seoul

    Dong Ho Kang, MD

    Dong Ho Kang, MD

    Recruiting

  • Kyung Hee University Hospital

    Seoul

    Won Kim, MD

    Won Kim, MD

    Recruiting

  • Seoul Metropolitan Boramae Hospital

    Seoul

    Woo Young Jung, MD

    Woo Young Jung, MD

    Recruiting

  • Seoul National University Hospital

    Seoul

    Bon Kwon Koo, MD

    Bon Kwon Koo, MD

    Recruiting

  • Soonchunhyang University Seoul Hospital

    Seoul

    Deok Won Bang, MD

    Deok Won Bang, MD

    Recruiting

  • Yeouido St. Mary's Hospital, Catholic University of Korea

    Seoul

    Chul Soo Park, MD

    Chul Soo Park, MD

    Recruiting

  • Ajou University Hospital

    Suwon

    Myoung Ho Yoon, MD

    Myoung Ho Yoon, MD

    Recruiting

  • St. Vincent's Hospital, Catholic University of Korea

    Suwon

    Sung Ho Heo, MD

    Sung Ho Heo, MD

    Recruiting

  • Ulsan University Hospital

    Ulsan

    Kyung Min Park, MD

    Kyung Min Park, MD

    Recruiting

  • Yongin Severance Hospital

    Yŏngin

    Yong Chul Kim, MD

    Yong Chul Kim, MD

    Recruiting

Other trials in South Korea

Japan3 sites, 2 recruiting

  • Japanese Red Cross Musashino Hospital

    Tokyo

    Ashikaga Takashi, MD

    Ashikaga Takashi, MD

    Recruiting

  • NTT East Japan Kanto Hospital

    Tokyo

    Withdrawn

  • Tsuchiura Kyodo General Hospital

    Tsuchiura

    Kakuta Tsunekazu, MD

    Kakuta Tsunekazu, MD

    Recruiting

Other trials in Japan

Hong Kong2 sites, 2 recruiting

  • Princess Margret Hospital( HongKong)

    Hong Kong

    Raymond Fung, MD

    Raymond Fung, MD

    Not yet recruiting

  • Queen Mary Hospital

    Hong Kong

    Chi Simon Lam Cheung, MD

    Chi Simon Lam Cheung, MD

    Not yet recruiting

Other trials in Hong Kong

India1 site, 1 recruiting

  • Manipal Hospital

    Bangalore

    Singh Chadha Davinder, MD

    Singh Chadha Davinder, MD

    Recruiting

Other trials in India

Taiwan1 site, 1 recruiting

  • Cheng Hsin General Hospital

    Taipei

    Wei-Hsian Yin, MD

    Wei-Hsian Yin, MD

    Recruiting

Other trials in Taiwan

About this study

Official title: 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).

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.

Being tested
FFR-Guided PCI, Angiography-Guided PCI
Keywords
Fractional Flow Reserve, Percutaneous Coronary Intervention
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FFR-Guided PCIProcedure or surgery

    Fractional Flow Reserve-Guided PCI

  • Angiography-Guided PCIProcedure or surgery

    Angiography-Guided PCI

Study groups in NCT05829889
Study groupRoleWhat they receive
FFR-guided Left Main PCIExperimentalNot described
Receives: Procedure: FFR-Guided PCI
Angiography-Guided PCIActive comparatorNot described
Receives: Procedure: Angiography-Guided PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (16)

  1. The event rate of death from any causes

    Measured: 2 years

  2. The event rate of myocardial infarction

    any, spontaneous or procedural myocardial infarction

    Measured: 2 years

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

    Measured: 2 years

  4. The event rate of repeat revascularization

    Measured: 2 years

  5. The composite event rate of death or myocardial infarction

    Measured: 2 years

  6. The event rate of stent thrombosis

    Stent thrombosis by Academic Research Consortium (ARC) definition

    Measured: 2 years

  7. The event rate of stroke

    Measured: 2 years

  8. The event rate of bleeding complications

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

    Measured: 2 years

  9. Procedure time

    Measured: 1 day

  10. Amount of contrast agent used

    Measured: 1 day

  11. Length of hospital stay

    Measured: an average of 7 day

  12. The event rate of rehospitalization

    Rehospitalization from any, cardiac, or noncardiac causes

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  16. Number of anti-anginal medications

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study start25 Apr 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
960 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05829889
Sponsor's protocol ID
AMCCV2023-02
Acronym
FATE-MAIN
Status last verified
Jun 2026
First submitted
30 Mar 2023
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing FFR-Guided PCI and Angiography-Guided PCI in people with Coronary Artery Disease Left Main and Coronary Artery Disease, run by Seung-Jung Park at 49 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in South Korea, Japan, Hong Kong, India, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Duk-woo Park, MD (dwpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The composite event rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05829889.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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