Study of the Natural History of FFR Guided Percutaneous Coronary Intervention

NCT ID: NCT01366404

Last Updated: 2024-11-14

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2037-04-30

Brief Summary

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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

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

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FFR

Patients who had FFR measurement

No interventions assigned to this group

Eligibility Criteria

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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


* 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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role collaborator

Seung-Jung Park

OTHER

Sponsor Role lead

Responsible Party

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Seung-Jung Park

Professor, Division of Cardiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Seung-Jung Park, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status RECRUITING

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, , South Korea

Site Status RECRUITING

Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status RECRUITING

Gangwon National Univ. Hospital

Chuncheon, , South Korea

Site Status RECRUITING

Daegu Catholic University Center

Daegu, , South Korea

Site Status RECRUITING

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status RECRUITING

Kyungpook National university hospital

Daegu, , South Korea

Site Status RECRUITING

Yeungnam University Medical Center

Daegu, , South Korea

Site Status RECRUITING

Chungnam National University Hospital

Daejeon, , South Korea

Site Status RECRUITING

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

Daejeon, , South Korea

Site Status RECRUITING

Gangneung Asan Hospital

Gangneung, , South Korea

Site Status RECRUITING

Chonnam National University Hospital

Gwangju, , South Korea

Site Status RECRUITING

Inje University Ilsan Paik Hospital

Ilsan, , South Korea

Site Status RECRUITING

Dong-A Medical Center

Pusan, , South Korea

Site Status RECRUITING

Pusan National University Hospital

Pusan, , South Korea

Site Status RECRUITING

Seoul university Bundang hospital

Seongnam, , South Korea

Site Status RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Hallym University Kangdong Sacred Heart Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Anam Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Kyung-Hee University Hospital at Kangdong

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

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

Seoul, , South Korea

Site Status RECRUITING

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

Seoul, , South Korea

Site Status RECRUITING

Ulsan University Hospital

Ulsan, , South Korea

Site Status RECRUITING

Wonju Severance Christian Hospital

Wŏnju, , South Korea

Site Status RECRUITING

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seung-Jung Park, MD, PhD

Role: CONTACT

Jung-min Ahn, MD

Role: CONTACT

Facility Contacts

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Hyun-sook Kim, MD

Role: primary

Nae-hee Lee, MD

Role: primary

Sang-yeub Lee, MD

Role: primary

Bong-ki Lee, MD

Role: primary

Bong-ki Kim, MD

Role: backup

Jin-bae Lee, MD

Role: primary

Chang-wook Nam, MD

Role: primary

Hun-sik Park, MD

Role: primary

Jong-seon Park, MD

Role: primary

Si-wan Choi, MD

Role: primary

Sung-ho Her, MD

Role: primary

Sang-sig Jung, MD

Role: primary

Young-jun Hong, MD

Role: primary

Joon-hyung Doh, MD

Role: primary

Kyung-il Park, MD

Role: primary

Taeg-jong Hong, MD

Role: primary

In-ho Chae, MD

Role: primary

Seung-jung Park, MD

Role: primary

Seung-jung Park, MD

Role: backup

Byoung-kwon Lee, MD

Role: primary

Kyoo-rok Han, MD

Role: primary

Do-sun Lim, MD

Role: primary

Seung-un Na, MD

Role: primary

Jong-jin Kim, MD

Role: primary

Woo-young Chung, MD

Role: primary

Bon-kwon Koo, MD

Role: primary

Ki-bae Seung, MD

Role: primary

Chul-soo Park, MD

Role: primary

Eun-seok Shin, MD

Role: primary

Jung-han Yoon, MD

Role: primary

Jun-hong Kim, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32345039 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29895713 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29529177 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28851731 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28356440 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27609817 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23787231 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23078732 (View on PubMed)

Other Identifiers

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CVRF2010-09

Identifier Type: -

Identifier Source: org_study_id

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