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Coronary Artery DiseaseIRIS FFRNCT01366404

Study of the Natural History of FFR Guided Percutaneous Coronary Intervention

An observational study of Coronary Artery Disease, run by Seung-Jung Park at 29 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

About 20,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for the natural history of coronary lesions at 2 years clinical and imaging follow-up. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Coronary Artery Disease
How many people
20,000 participants
Where
29 sitesSouth Korea
Study dates
Jun 2011to Apr 2037
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who had FFR measurement

Who may be able to join

  • Age 35 years and older
  • FFR measurement on one and more coronary artery stenosis
  • Willing and able to provide informed, written consent

Who cannot join

  • Stenosis with TIMI<3 flow
  • Graft vessel
  • Ejection fraction < 30%
  • Angiographic evidence of extreme tortuosity or calcified coronary vessels
  • Suspected coronary spasm even after sufficient nitrate injected
  • Life expectancy <2 year
Show all 11Show fewer
  • Planned cardiac surgery or planned major non cardiac surgery
  • Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study
  • Imaging study specific exclusion criteria
  • visually-estimated angiographic reference segment diameter of <2.75mm or >4.0mm
  • Inappropriate for IVUS/VH/OCT procedures : inability for imaging wire or catheter to pass through the tight stenosis, severe calcification, angulation

Trial locations and contacts

29 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Seung-Jung Park, MD, PhD contact

sjpark@amc.seoul.kr

Jung-min Ahn, MD contact

drjmahn@gmail.com

29 sites in 1 country

South Korea29 sites, 29 recruiting

  • Hallym University Sacred Heart Hospital

    Anyang

    Hyun-sook Kim, MD

    Hyun-sook Kim, MD

    Recruiting

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si

    Nae-hee Lee, MD

    Nae-hee Lee, MD

    Recruiting

  • Chungbuk National University Hospital

    Cheongju-si

    Sang-yeub Lee, MD

    Sang-yeub Lee, MD

    Recruiting

  • Gangwon National Univ. Hospital

    Chuncheon

    Bong-ki Lee, MD

    Bong-ki Kim, MD

    Recruiting

  • Daegu Catholic University Center

    Daegu

    Jin-bae Lee, MD

    Jin-bae Lee, MD

    Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Chang-wook Nam, MD

    Chang-wook Nam, MD

    Recruiting

  • Kyungpook National university hospital

    Daegu

    Hun-sik Park, MD

    Hun-sik Park, MD

    Recruiting

  • Yeungnam University Medical Center

    Daegu

    Jong-seon Park, MD

    Jong-seon Park, MD

    Recruiting

  • Chungnam National University Hospital

    Daejeon

    Si-wan Choi, MD

    Si-wan Choi, MD

    Recruiting

  • The Catholic University of Korea, Deajeon St.Mary's hospital

    Daejeon

    Sung-ho Her, MD

    Sung-ho Her, MD

    Recruiting

  • Gangneung Asan Hospital

    Gangneung

    Sang-sig Jung, MD

    Sang-sig Jung, MD

    Recruiting

  • Chonnam National University Hospital

    Gwangju

    Young-jun Hong, MD

    Young-jun Hong, MD

    Recruiting

  • Inje University Ilsan Paik Hospital

    Ilsan

    Joon-hyung Doh, MD

    Joon-hyung Doh, MD

    Recruiting

  • Dong-A Medical Center

    Pusan

    Kyung-il Park, MD

    Kyung-il Park, MD

    Recruiting

  • Pusan National University Hospital

    Pusan

    Taeg-jong Hong, MD

    Taeg-jong Hong, MD

    Recruiting

  • Seoul university Bundang hospital

    Seongnam

    In-ho Chae, MD

    In-ho Chae, MD

    Recruiting

  • Asan Medical Center

    Seoul

    Seung-jung Park, MD, sjpark@amc.seoul.kr

    Seung-jung Park, MD

    Recruiting

  • Gangnam Severance Hospital

    Seoul

    Byoung-kwon Lee, MD

    Byoung-kwon Lee, MD

    Recruiting

  • Hallym University Kangdong Sacred Heart Hospital

    Seoul

    Kyoo-rok Han, MD

    Kyoo-rok Han, MD

    Recruiting

  • Korea University Anam Hospital

    Seoul

    Do-sun Lim, MD

    Do-sun Lim, MD

    Recruiting

  • Korea University Guro Hospital

    Seoul

    Seung-un Na, MD

    Seung-un Na, MD

    Recruiting

  • Kyung-Hee University Hospital at Kangdong

    Seoul

    Jong-jin Kim, MD

    Jong-jin Kim, MD

    Recruiting

  • Seoul National University Boramae Medical Center

    Seoul

    Woo-young Chung, MD

    Woo-young Chung, MD

    Recruiting

  • Seoul National University Hospital

    Seoul

    Bon-kwon Koo, MD

    Bon-kwon Koo, MD

    Recruiting

  • The Catholic University of Korea, Seoul St.Mary's Hospital

    Seoul

    Ki-bae Seung, MD

    Ki-bae Seung, MD

    Recruiting

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

    Seoul

    Chul-soo Park, MD

    Chul-soo Park, MD

    Recruiting

  • Ulsan University Hospital

    Ulsan

    Eun-seok Shin, MD

    Eun-seok Shin, MD

    Recruiting

  • Wonju Severance Christian Hospital

    Wŏnju

    Jung-han Yoon, MD

    Jung-han Yoon, MD

    Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan

    Jun-hong Kim, MD

    Jun-hong Kim, MD

    Recruiting

Other trials in South Korea

About this study

Official title: A Multicenter, Prospective Cohort to Evaluate the Natural History of FFR Guided Percutaneous Coronary Intervention

About 20,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for the natural history of coronary lesions at 2 years clinical and imaging follow-up.

Read the detailed description

This is a multicenter, prospective cohort. About 20,000 patients with FFR will be enrolled at multi centres in Korea.

Keywords
FFR
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01366404
Study groupRoleWhat they receive
FFRPatients who had FFR measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target vessel failure

    Measured: 2 year after index FFR measurement

  2. composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events

    Measured: at 2 year after index FFR measurement

Secondary outcomes (18)

  1. Death (all cause and cardiac)

    Measured: at 2 year after index FFR measurement

  2. MI

    Measured: at 2 year after index FFR measurement

  3. Target vessel revascularization

    Measured: at 2 year after index FFR measurement

  4. Target lesion revascularization

    Measured: at 2 year after index FFR measurement

  5. Any re-hospitalization with a cardiac cause

    Measured: 2 year follow-up after index FFR measurement

  6. cardiac death and myocardial infarction

    Measured: 2 year follow-up after index FFR measurement

  7. stented lesion related event including death, myocardial infarction, repeat revascularization

    Measured: 2 year follow-up after index FFR measurement

  8. stroke

    Measured: 2 year follow-up after index FFR measurement

  9. stent thrombosis

    Measured: 2 year follow-up after index FFR measurement

  10. anginal status

    Measured: 2 year follow-up after index FFR measurement

  11. number of anti-anginal medication prescribed

    Measured: 2 year follow-up after index FFR measurement

  12. complication of FFR measurement

    Measured: 2 year follow-up after index FFR measurement

  13. clinical predictors of events

    Measured: 2 year follow-up after index FFR measurement

  14. change in plaque composition (%necrotic core volume) in target segment

    Measured: 2 year follow-up after index FFR measurement

  15. change in plaque type assessed by VH(Virtual Histology) and OCT(Optical coherence tomography)

    Measured: 2 year follow-up after index FFR measurement

  16. change in total atheroma volume and percent atheroma volume

    Measured: 2 year follow-up after index FFR measurement

  17. change in IVUS-measured MLA

    Measured: 2 year follow-up after index FFR measurement

  18. change in FFR

    Measured: 2 year follow-up after index FFR measurement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionApr 2037 (estimated)
  4. Study completionApr 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01366404
Sponsor's protocol ID
CVRF2010-09
Acronym
IRIS FFR
Status last verified
Mar 2026
First submitted
2 Jun 2011
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lim SM, Ahn JM, Kang DY, Shin ES, Koo BK, Nam CW, Park H, Lee BK, Lee JB, Wee SB, Jo HH, Lee JM, Park YS, Kim JH, Kim HJ, Park DW, Park SJ. Contrasting Prognostic Value of Discordance Between Resting Distal-to-Aortic Coronary Pressure Ratio and Fractional Flow Reserve in Coronary Artery Disease. Circ Cardiovasc Interv. 2026 Sep 24:e016865. doi: 10.1161/CIRCINTERVENTIONS.126.016865. Online ahead of print.

    PubMed 42779535

  • Ahn JM, Park DW, Kim SO, Kang DY, Lee CH, Lee PH, Lee SW, Park SW, Park SJ. Prognostic Value of Resting Distal-to-Aortic Coronary Pressure in Clinical Practice. Circ Cardiovasc Interv. 2020 May;13(5):e007868. doi: 10.1161/CIRCINTERVENTIONS.118.007868. Epub 2020 Apr 29.

    PubMed 32345039

  • Kang DY, Ahn JM, Kim YW, Moon JY, Lee JS, Koo BK, Lee PH, Park DW, Kang SJ, Lee SW, Kim YH, Park SW, Park SJ. Impact of Coronary Lesion Geometry on Fractional Flow Reserve: Data From Interventional Cardiology Research In-Cooperation Society-Fractional Flow Reserve and Intravascular Ultrasound Registry. Circ Cardiovasc Imaging. 2018 Jun;11(6):e007087. doi: 10.1161/CIRCIMAGING.117.007087.

    PubMed 29895713

  • Kang DY, Ahn JM, Lee CH, Lee PH, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park SJ. Deferred vs. performed revascularization for coronary stenosis with grey-zone fractional flow reserve values: data from the IRIS-FFR registry. Eur Heart J. 2018 May 7;39(18):1610-1619. doi: 10.1093/eurheartj/ehy079.

    PubMed 29529177

  • Lee JM, Hwang D, Park J, Zhang J, Tong Y, Kim CH, Bang JI, Suh M, Paeng JC, Cheon GJ, Koo BK. Exploring Coronary Circulatory Response to Stenosis and Its Association With Invasive Physiologic Indexes Using Absolute Myocardial Blood Flow and Coronary Pressure. Circulation. 2017 Nov 7;136(19):1798-1808. doi: 10.1161/CIRCULATIONAHA.117.029911. Epub 2017 Aug 29.

    PubMed 28851731

  • Ahn JM, Park DW, Shin ES, Koo BK, Nam CW, Doh JH, Kim JH, Chae IH, Yoon JH, Her SH, Seung KB, Chung WY, Yoo SY, Lee JB, Choi SW, Park K, Hong TJ, Lee SY, Han M, Lee PH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park SJ; IRIS-FFR Investigatorsdagger. Fractional Flow Reserve and Cardiac Events in Coronary Artery Disease: Data From a Prospective IRIS-FFR Registry (Interventional Cardiology Research Incooperation Society Fractional Flow Reserve). Circulation. 2017 Jun 6;135(23):2241-2251. doi: 10.1161/CIRCULATIONAHA.116.024433. Epub 2017 Mar 29.

    PubMed 28356440

  • Lee JM, Kim CH, Koo BK, Hwang D, Park J, Zhang J, Tong Y, Jeon KH, Bang JI, Suh M, Paeng JC, Cheon GJ, Na SH, Ahn JM, Park SJ, Kim HS. Integrated Myocardial Perfusion Imaging Diagnostics Improve Detection of Functionally Significant Coronary Artery Stenosis by 13N-ammonia Positron Emission Tomography. Circ Cardiovasc Imaging. 2016 Sep;9(9):e004768. doi: 10.1161/CIRCIMAGING.116.004768.

    PubMed 27609817

  • Kang SJ, Ahn JM, Han S, Lee JY, Kim WJ, Park DW, Lee SW, Kim YH, Lee CW, Park SW, Mintz GS, Park SJ. Sex differences in the visual-functional mismatch between coronary angiography or intravascular ultrasound versus fractional flow reserve. JACC Cardiovasc Interv. 2013 Jun;6(6):562-8. doi: 10.1016/j.jcin.2013.02.016.

    PubMed 23787231

  • Park SJ, Kang SJ, Ahn JM, Shim EB, Kim YT, Yun SC, Song H, Lee JY, Kim WJ, Park DW, Lee SW, Kim YH, Lee CW, Mintz GS, Park SW. Visual-functional mismatch between coronary angiography and fractional flow reserve. JACC Cardiovasc Interv. 2012 Oct;5(10):1029-36. doi: 10.1016/j.jcin.2012.07.007.

    PubMed 23078732

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Seung-Jung Park at 29 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seung-Jung Park, MD, PhD (sjpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target vessel failure (time frame: 2 year after index FFR measurement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01366404, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

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