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NCT Number: NCT05829889

Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant 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).

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margret Hospital( HongKong), Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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;
  • Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial.
  • Screening failed before any interventional factor is involved.
  • 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.

Treatment and study plan

FFR-guided PCI

Procedure

Fractional Flow Reserve-Guided PCI

Angiography-guided PCI

Procedure

Angiography-Guided PCI

Primary outcomes

  1. The composite event rate

    Time frame: 2 years

    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.

Secondary outcomes

  1. The event rate of death from any causes

    Time frame: 2 years

  2. The event rate of myocardial infarction

    Time frame: 2 years

    any, spontaneous or procedural myocardial infarction

  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

    Time frame: 2 years

    Stent thrombosis by Academic Research Consortium (ARC) definition

  7. The event rate of stroke

    Time frame: 2 years

  8. The event rate of bleeding complications

    Time frame: 2 years

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

  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

    Time frame: 2 years

    Rehospitalization from any, cardiac, or noncardiac causes

  13. Functional class

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

    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.

  14. Change of angina-related quality of life index

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

    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.

  15. Change of health-related quality of life index

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

    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.

  16. Number of anti-anginal medications

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

Study contacts

Contact information is provided by the study sponsor or research team.

Duk-woo Park, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

A Comparison of Fractional Flow Reserve- Versus Angiography-Guided Percutaneous Coronary Intervention in Patients With Left Main Coronary Artery Disease

Acronym: FATE-MAIN

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 26, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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