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Recruiting NCT01366404

Study of the Natural History of FFR Guided Percutaneous Coronary Intervention

— Observational Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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

Primary outcome measures

  • Target vessel failure [Time frame: 2 year after index FFR measurement]
  • composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events [Time frame: at 2 year after index FFR measurement]
Secondary outcome measures (12)
  • Death (all cause and cardiac) [Time frame: at 2 year after index FFR measurement]
  • MI [Time frame: at 2 year after index FFR measurement]
  • Target vessel revascularization [Time frame: at 2 year after index FFR measurement]
  • Target lesion revascularization [Time frame: at 2 year after index FFR measurement]
  • Any re-hospitalization with a cardiac cause [Time frame: 2 year follow-up after index FFR measurement]
  • cardiac death and myocardial infarction [Time frame: 2 year follow-up after index FFR measurement]
  • stented lesion related event including death, myocardial infarction, repeat revascularization [Time frame: 2 year follow-up after index FFR measurement]
  • stroke [Time frame: 2 year follow-up after index FFR measurement]
  • stent thrombosis [Time frame: 2 year follow-up after index FFR measurement]
  • anginal status [Time frame: 2 year follow-up after index FFR measurement]
  • number of anti-anginal medication prescribed [Time frame: 2 year follow-up after index FFR measurement]
  • complication of FFR measurement [Time frame: 2 year follow-up after index FFR measurement]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 29 centers
  • Hallym University Sacred Heart Hospital — Anyang
  • Soon Chun Hyang University Hospital Bucheon — Bucheon-si
  • Chungbuk National University Hospital — Cheongju-si
  • Gangwon National Univ. Hospital — Chuncheon
  • Daegu Catholic University Center — Daegu
  • Keimyung University Dongsan Medical Center — Daegu
  • Kyungpook National university hospital — Daegu
  • Yeungnam University Medical Center — Daegu
  • … and 21 more centers

Publications

  • 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. PMID 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. PMID 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. PMID 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. PMID 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 I PMID 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. PMID 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. PMID 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. PMID 23078732

Identifiers

NCT: NCT01366404 · CVRF2010-09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗