Clinical trial NCT01366404: Study of the Natural History of FFR Guided Percutaneous Coronary Intervention
Official title: A Multicenter, Prospective Cohort to Evaluate the Natural History of FFR Guided Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: FFR
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
name: Abbott Medical Devices
First posted: 2011-06-06
Enrollment: 20000
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had FFR measurement

Brief 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.

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

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

Primary outcomes:
measure: Target vessel failure
timeFrame: 2 year after index FFR measurement
measure: composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events
timeFrame: at 2 year after index FFR measurement
Secondary outcomes:
measure: Death (all cause and cardiac)
timeFrame: at 2 year after index FFR measurement
measure: MI
timeFrame: at 2 year after index FFR measurement
measure: Target vessel revascularization
timeFrame: at 2 year after index FFR measurement
measure: Target lesion revascularization
timeFrame: at 2 year after index FFR measurement
measure: Any re-hospitalization with a cardiac cause
timeFrame: 2 year follow-up after index FFR measurement
measure: cardiac death and myocardial infarction
timeFrame: 2 year follow-up after index FFR measurement
measure: stented lesion related event including death, myocardial infarction, repeat revascularization
timeFrame: 2 year follow-up after index FFR measurement
measure: stroke
timeFrame: 2 year follow-up after index FFR measurement
measure: stent thrombosis
timeFrame: 2 year follow-up after index FFR measurement
measure: anginal status
timeFrame: 2 year follow-up after index FFR measurement
measure: number of anti-anginal medication prescribed
timeFrame: 2 year follow-up after index FFR measurement
measure: complication of FFR measurement
timeFrame: 2 year follow-up after index FFR measurement
measure: clinical predictors of events
timeFrame: 2 year follow-up after index FFR measurement
measure: change in plaque composition (%necrotic core volume) in target segment
timeFrame: 2 year follow-up after index FFR measurement
measure: change in plaque type assessed by VH(Virtual Histology) and OCT(Optical coherence tomography)
timeFrame: 2 year follow-up after index FFR measurement
measure: change in total atheroma volume and percent atheroma volume
timeFrame: 2 year follow-up after index FFR measurement
measure: change in IVUS-measured MLA
timeFrame: 2 year follow-up after index FFR measurement
measure: change in FFR
timeFrame: 2 year follow-up after index FFR measurement
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National university hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Deajeon St.Mary's hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A Medical Center
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul university Bundang hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung-Hee University Hospital at Kangdong
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.