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).
Eligibility
Sex
ALL
Min age
20 Years
Max age
—
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:
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.
Primary outcome measure(s)
The composite event rate — 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.
Trial sites (49)
Facility
City
Region
Status
Princess Margret Hospital( HongKong)
Hong Kong
Hong Kong
Not Yet Recruiting
Queen Mary Hospital
Hong Kong
Hong Kong
Not Yet Recruiting
Manipal Hospital
Bangalore
India
Recruiting
Japanese Red Cross Musashino Hospital
Tokyo
Japan
Recruiting
NTT East Japan Kanto Hospital
Tokyo
Japan
Withdrawn
Tsuchiura Kyodo General Hospital
Tsuchiura
Japan
Recruiting
Asan Medical Center
Seoul
Songpa-gu
Recruiting
Korea University Ansan Hospital
Ansan
South Korea
Terminated
Hallym University Sacred Heart Hospital
Anyang
South Korea
Recruiting
Bucheon Sejong Hospital
Bucheon-si
South Korea
Recruiting
Dong-A University Hospital
Busan
South Korea
Recruiting
Pusan National University Hospital
Busan
South Korea
Recruiting
Pusan National University Yangsan Hospital
Busan
South Korea
Terminated
Changwon Gyeongsang National University Hospital
Changwon
South Korea
Recruiting
Kangwon National University Hospital
Chuncheon
South Korea
Recruiting
Daegu Catholic University Medical Center
Daegu
South Korea
Recruiting
Keimyung University Dongsan Medical Center
Daegu
South Korea
Recruiting
Yeungnam University Hospital
Daegu
South Korea
Recruiting
Chungnam National University Hospital
Daejeon
South Korea
Recruiting
Daejeon St. Mary's Hospital, Catholic University of Korea
Daejeon
South Korea
Recruiting
Gangneung Asan Hospital
Gangneung
South Korea
Recruiting
Chonnam National University Hospital
Gwangju
South Korea
Recruiting
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong
South Korea
Recruiting
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si
South Korea
Recruiting
CHA Ilsan Medical Center
Ilsan
South Korea
Terminated
Ilsan Myongji Hospital
Ilsan
South Korea
Terminated
Inje University Ilsan Paik Hospital
Ilsan
South Korea
Not Yet Recruiting
National Health Insurance Service Ilsan Hospital
Ilsan
South Korea
Recruiting
Gachon University Gil Medical Center
Incheon
South Korea
Recruiting
Inha University Hospital
Incheon
South Korea
Recruiting
Jeju National University Hospital
Jeju City
South Korea
Terminated
Chungnam National University Sejong Hospital
Seongam
South Korea
Recruiting
Seoul National University Bundang Hospital
Seongnam
South Korea
Recruiting
Chung-Ang University Hospital
Seoul
South Korea
Recruiting
Eunpyeong St. Mary's Hospital, Catholic University of Korea
Seoul
South Korea
Recruiting
Hanyang University Hospital
Seoul
South Korea
Recruiting
Kangbuk Samsung Hospital
Seoul
South Korea
Not Yet Recruiting
Korea University Anam Hospital
Seoul
South Korea
Terminated
Korea University Guro Hospital
Seoul
South Korea
Recruiting
Kyung Hee University Hospital
Seoul
South Korea
Recruiting
+ 9 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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