Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT05829889

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

Led by Seung-Jung Park · Updated on 2025-12-29

960

Participants Needed

48

Research Sites

187 weeks

Total Duration

On this page

Sponsors

S

Seung-Jung Park

Lead Sponsor

C

CardioVascular Research Foundation, Korea

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 years or older with angina and/or evidence of myocardial ischemia
  • Significant new left main coronary artery disease with 50% or greater narrowing suitable for PCI with drug-eluting stent
  • Patient or guardian agrees to study protocol and follow-up schedule and provides written informed consent
Not Eligible

You will not qualify if you...

  • Chronic total occlusion of left anterior descending or left circumflex coronary artery
  • Extremely calcified or tortuous vessels preventing FFR measurement
  • Complex coronary disease or cardiac conditions making PCI unsuitable
  • Recent ST elevation myocardial infarction within 7 days before randomization
  • Cardiogenic shock or need for mechanical or pharmacologic hemodynamic support
  • Severe left ventricular dysfunction with ejection fraction below 30%
  • Need for other cardiac surgery such as valve replacement or aorta surgery
  • Inability or contraindication to take aspirin or P2Y12 inhibitors
  • Prior PCI of the left main trunk
  • Prior coronary artery bypass graft surgery
  • Planned surgery within 1 year
  • End-stage renal disease requiring renal replacement therapy
  • Liver cirrhosis
  • Pregnant or lactating women
  • Medical condition with life expectancy less than 2 years
  • Active participation in another investigational drug or device study without completed primary endpoint follow-up, except certain observational or academic trials as per investigator discretion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 48 locations

1

Princess Margret Hospital( HongKong)

Hong Kong, Hong Kong

Not Yet Recruiting

2

Queen Mary Hospital

Hong Kong, Hong Kong

Not Yet Recruiting

3

Manipal Hospital

Bangalore, India

Actively Recruiting

4

Japanese Red Cross Musashino Hospital

Tokyo, Japan

Not Yet Recruiting

5

NTT East Japan Kanto Hospital

Tokyo, Japan

Not Yet Recruiting

6

Tsuchiura Kyodo General Hospital

Tsuchiura, Japan

Actively Recruiting

7

Asan Medical Center

Seoul, Songpa-gu, South Korea, 138-736

Actively Recruiting

8

Korea University Ansan Hospital

Ansan, South Korea

Not Yet Recruiting

9

Hallym University Sacred Heart Hospital

Anyang, South Korea

Actively Recruiting

10

Bucheon Sejong Hospital

Bucheon-si, South Korea

Actively Recruiting

11

Dong-A University Hospital

Busan, South Korea

Actively Recruiting

12

Pusan National University Hospital

Busan, South Korea

Actively Recruiting

13

Pusan National University Yangsan Hospital

Busan, South Korea

Not Yet Recruiting

14

Changwon Gyeongsang National University Hospital

Changwon, South Korea

Actively Recruiting

15

Kangwon National University Hospital

Chuncheon, South Korea

Actively Recruiting

16

Daegu Catholic University Medical Center

Daegu, South Korea

Actively Recruiting

17

Keimyung University Dongsan Medical Center

Daegu, South Korea

Actively Recruiting

18

Yeungnam University Hospital

Daegu, South Korea

Actively Recruiting

19

Chungnam National University Hospital

Daejeon, South Korea

Actively Recruiting

20

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

Daejeon, South Korea

Actively Recruiting

21

Gangneung Asan Hospital

Gangneung, South Korea

Actively Recruiting

22

Chonnam National University Hospital

Gwangju, South Korea

Actively Recruiting

23

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, South Korea

Actively Recruiting

24

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, South Korea

Actively Recruiting

25

CHA Ilsan Medical Center

Ilsan, South Korea

Not Yet Recruiting

26

Ilsan Myongji Hospital

Ilsan, South Korea

Not Yet Recruiting

27

Inje University Ilsan Paik Hospital

Ilsan, South Korea

Not Yet Recruiting

28

National Health Insurance Service Ilsan Hospital

Ilsan, South Korea

Actively Recruiting

29

Gachon University Gil Medical Center

Incheon, South Korea

Actively Recruiting

30

Inha University Hospital

Incheon, South Korea

Actively Recruiting

31

Jeju National University Hospital

Jeju City, South Korea

Not Yet Recruiting

32

Chungnam National University Sejong Hospital

Seongam, South Korea

Actively Recruiting

33

Seoul National University Bundang Hospital

Seongnam, South Korea

Actively Recruiting

34

Chung-Ang University Hospital

Seoul, South Korea

Actively Recruiting

35

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

Seoul, South Korea

Actively Recruiting

36

Hanyang University Hospital

Seoul, South Korea

Actively Recruiting

37

Korea University Anam Hospital

Seoul, South Korea

Actively Recruiting

38

Korea University Guro Hospital

Seoul, South Korea

Actively Recruiting

39

Kyung Hee University Hospital

Seoul, South Korea

Actively Recruiting

40

Seoul Metropolitan Boramae Hospital

Seoul, South Korea

Actively Recruiting

41

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

42

Soonchunhyang University Seoul Hospital

Seoul, South Korea

Actively Recruiting

43

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

Seoul, South Korea

Actively Recruiting

44

Ajou University Hospital

Suwon, South Korea

Actively Recruiting

45

St. Vincent's Hospital, Catholic University of Korea

Suwon, South Korea

Actively Recruiting

46

Ulsan University Hospital

Ulsan, South Korea

Actively Recruiting

47

Yongin Severance Hospital

Yŏngin, South Korea

Actively Recruiting

48

Cheng Hsin General Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

D

Duk-woo Park, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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