Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease
NCT ID: NCT05829889
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
960 participants
INTERVENTIONAL
2024-04-25
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FFR-guided Left Main PCI
FFR-Guided PCI
Fractional Flow Reserve-Guided PCI
Angiography-Guided PCI
Angiography-Guided PCI
Angiography-Guided PCI
Interventions
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FFR-Guided PCI
Fractional Flow Reserve-Guided PCI
Angiography-Guided PCI
Angiography-Guided PCI
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
ALL
No
Sponsors
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CardioVascular Research Foundation, Korea
OTHER
Seung-Jung Park
OTHER
Responsible Party
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Seung-Jung Park
Professor, Cardiology, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center
Principal Investigators
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Duk-woo Park, MD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Princess Margret Hospital( HongKong)
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Manipal Hospital
Bangalore, , India
Japanese Red Cross Musashino Hospital
Tokyo, , Japan
NTT East Japan Kanto Hospital
Tokyo, , Japan
Tsuchiura Kyodo General Hospital
Tsuchiura, , Japan
Asan Medical Center
Seoul, Songpa-gu, South Korea
Korea University Ansan Hospital
Ansan, , South Korea
Hallym University Sacred Heart Hospital
Anyang, , South Korea
Bucheon Sejong Hospital
Bucheon-si, , South Korea
Dong-A University Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Pusan National University Yangsan Hospital
Busan, , South Korea
Changwon Gyeongsang National University Hospital
Changwon, , South Korea
Kangwon National University Hospital
Chuncheon, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yeungnam University Hospital
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Daejeon St. Mary's Hospital, Catholic University of Korea
Daejeon, , South Korea
Gangneung Asan Hospital
Gangneung, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, , South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, , South Korea
CHA Ilsan Medical Center
Ilsan, , South Korea
Ilsan Myongji Hospital
Ilsan, , South Korea
Inje University Ilsan Paik Hospital
Ilsan, , South Korea
National Health Insurance Service Ilsan Hospital
Ilsan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Jeju National University Hospital
Jeju City, , South Korea
Chungnam National University Sejong Hospital
Seongam, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Eunpyeong St. Mary's Hospital, Catholic University of Korea
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Seoul Metropolitan Boramae Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Soonchunhyang University Seoul Hospital
Seoul, , South Korea
Yeouido St. Mary's Hospital, Catholic University of Korea
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
St. Vincent's Hospital, Catholic University of Korea
Suwon, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Yongin Severance Hospital
Yŏngin, , South Korea
Cheng Hsin General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Raymond Fung, MD
Role: primary
Chi Simon Lam Cheung, MD
Role: primary
Singh Chadha Davinder, MD
Role: primary
Ashikaga Takashi, MD
Role: primary
Warisawa Takayuki, MD
Role: primary
Kakuta Tsunekazu, MD
Role: primary
Seung-jung Park, MD, PhD
Role: primary
Sun Won Kim, MD
Role: primary
Sang Ho Cho, MD
Role: primary
Ho-yeon Kim, MD
Role: primary
Yong Lak Cho, MD
Role: primary
Jung Chun Choi, MD
Role: primary
Guk Jin Chun, MD
Role: primary
Jae Seok Bae, MD
Role: primary
Bong Ki Lee, MD
Role: primary
Jin Bae Lee, MD
Role: primary
Chang Wook Nam, MD
Role: primary
Woong Kim, MD
Role: primary
Pil Sang Song, MD
Role: primary
Kyu Seob Lee, MD
Role: primary
Han Bit Park, MD
Role: primary
Young Joon Hong
Role: primary
Young Hoon Jung, MD
Role: primary
Jin Hwa Lee, MD
Role: primary
Won Jang Kim, MD
Role: primary
Yoon Hyung Cho, MD
Role: primary
Joon Hyung Do, MD
Role: primary
Ji Yong Jang, MD
Role: primary
Seung Hwan Han, MD
Role: primary
Sang Don Park, MD
Role: primary
Song Yi Kim, MD
Role: primary
Won Mook Hwang, MD
Role: primary
In Ho Chae, MD
Role: primary
Ho Yeon Won, MD
Role: primary
Jung Hoon Lee, MD
Role: primary
Young Hyo Lim, MD
Role: primary
Hyung Joon Joo, MD
Role: primary
Dong Ho Kang, MD
Role: primary
Won Kim, MD
Role: primary
Woo Young Jung, MD
Role: primary
Bon Kwon Koo, MD
Role: primary
Deok Won Bang, MD
Role: primary
Chul Soo Park, MD
Role: primary
Myoung Ho Yoon, MD
Role: primary
Sung Ho Heo, MD
Role: primary
Kyung Min Park, MD
Role: primary
Yong Chul Kim, MD
Role: primary
Wei-Hsian Yin, MD
Role: primary
Other Identifiers
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AMCCV2023-02
Identifier Type: -
Identifier Source: org_study_id