Comparing two methods for treating significant left main coronary artery disease

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

This study is testing whether two different ways of treating serious left main coronary artery disease can lead to better heart health for patients over two years.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 960 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Asan Medical Center (Academic / other)
• Locations: 48 sites (Hong Kong and 47 other locations)
• Trial ID: NCT05829889 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of two different approaches for treating significant left main coronary artery disease: angiography-guided Percutaneous Coronary Intervention (PCI) and Fractional Flow Reserve (FFR)-guided PCI. Participants will be monitored over a two-year period to assess the occurrence of major adverse cardiac events. The study will include patients with significant left main coronary artery disease who meet specific eligibility criteria. The goal is to determine if one method leads to better outcomes than the other.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 20 and older with significant left main coronary artery disease and evidence of myocardial ischemia.

Not a fit: Patients with chronic total occlusion of the left anterior descending or left circumflex coronary arteries or those with extremely calcified vessels may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective treatment approach for patients with significant left main coronary artery disease, potentially improving patient outcomes.

How similar studies have performed: Previous studies have shown varying success with similar approaches, but this specific comparison of FFR versus angiography in left main coronary artery disease is relatively novel.

Eligibility criteria

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.

Where this trial is running

Hong Kong and 47 other locations

• 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 (Not_yet_recruiting)
• NTT East Japan Kanto Hospital — Tokyo, Japan (Not_yet_recruiting)
• Tsuchiura Kyodo General Hospital — Tsuchiura, Japan (Recruiting)
• Asan Medical Center — Seoul, Songpa-gu, South Korea (Recruiting)
• Korea University Ansan Hospital — Ansan, South Korea (Not_yet_recruiting)
• 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 (Not_yet_recruiting)
• 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 (Not_yet_recruiting)
• Ilsan Myongji Hospital — Ilsan, South Korea (Not_yet_recruiting)
• 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 (Not_yet_recruiting)
• 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)
• Korea University Anam Hospital — Seoul, South Korea (Recruiting)
• Korea University Guro Hospital — Seoul, South Korea (Recruiting)
• Kyung Hee University Hospital — Seoul, South Korea (Recruiting)
• Seoul Metropolitan Boramae Hospital — Seoul, South Korea (Recruiting)
• Seoul National University Hospital — Seoul, South Korea (Recruiting)
• Soonchunhyang University Seoul Hospital — Seoul, South Korea (Recruiting)
• Yeouido St. Mary's Hospital, Catholic University of Korea — Seoul, South Korea (Recruiting)
• Ajou University Hospital — Suwon, South Korea (Recruiting)
• St. Vincent's Hospital, Catholic University of Korea — Suwon, South Korea (Recruiting)
• Ulsan University Hospital — Ulsan, South Korea (Recruiting)
• Yongin Severance Hospital — Yŏngin, South Korea (Recruiting)
• Cheng Hsin General Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Duk-woo Park, MD — Asan Medical Center
• Study coordinator: Duk-woo Park, MD

Conditions Coronary Artery Disease Left Main; Coronary Artery Disease; Fractional Flow Reserve; Percutaneous Coronary Intervention