🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT05829889
Recruiting Not applicable

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

NCT05829889 · tracked via the Priya Life Science India tracker
Sponsor
Seung-Jung Park
Phase
Not applicable
Started
2024-04-25
Last updated
2026-06-24

Condition(s) studied

Coronary Artery Disease Left MainCoronary Artery Disease

Investigational drug(s) / intervention(s)

FFR-Guided PCIAngiography-Guided PCI

FFR-Guided PCI: Fractional Flow Reserve-Guided PCI

Angiography-Guided PCI: Angiography-Guided PCI

Study 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 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)

Trial sites (49)

FacilityCityRegionStatus
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.

More Seung-Jung Park trials in India

Other trials for the same condition

Official registry record

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.

View NCT05829889 on ClinicalTrials.gov ↗ ← All trials in India