Study Results
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Basic Information
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COMPLETED
280 participants
OBSERVATIONAL
2019-07-30
2023-09-26
Brief Summary
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Detailed Description
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The aims of this study were:
1. To investigate diagnostic accuracy of angiography-based QFR for hemodynamic assessment of coronary artery stenosis compared to pressure wire-based FFR.
2. To compare the diagnostic performance of QFR versus % diameter stenosis (DS) in identifying physiologically significant coronary artery disease (CAD) using FFR as the reference standard.
3. To identify factors affecting QFR accuracy.
4. To compare the coronary CT data with QFR.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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QFR group
Patients suspected with coronary artery disease undergoing diagnostic coronary angiography with an indication for to perform invasive FFR
QFR
Patients suspected with CAD undergoing diagnostic coronary angiography with an indication for to perform invasive FFR were included. QFR was analyzed in an independent core laboratory (Uijeongbu Eulji Medical Center) using the software package QAngio XA 3D 2.1 (Medis Medical Imaging Systems, Leiden, the Netherlands).
Interventions
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QFR
Patients suspected with CAD undergoing diagnostic coronary angiography with an indication for to perform invasive FFR were included. QFR was analyzed in an independent core laboratory (Uijeongbu Eulji Medical Center) using the software package QAngio XA 3D 2.1 (Medis Medical Imaging Systems, Leiden, the Netherlands).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Primary myocardial or valvular disease
* Left ventricular ejection fraction ≤40%
* Patients with cardiogenic shock
19 Years
ALL
No
Sponsors
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Inje University Ilsan Paik Hospital
OTHER
Keimyung University Dongsan Medical Center
OTHER
Ulsan Medical Center
OTHER
Sejong General Hospital
OTHER
Chosun University Hospital
OTHER
Severance Hospital
OTHER
Ulsan University Hospital
OTHER
Uijeongbu Eulji Medical Center
UNKNOWN
Seoul National University Hospital
OTHER
Responsible Party
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Bon-Kwon Koo
Professor
Principal Investigators
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Bon-Kwon Koo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
van Nunen LX, Zimmermann FM, Tonino PA, Barbato E, Baumbach A, Engstrom T, Klauss V, MacCarthy PA, Manoharan G, Oldroyd KG, Ver Lee PN, Van't Veer M, Fearon WF, De Bruyne B, Pijls NH; FAME Study Investigators. Fractional flow reserve versus angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial. Lancet. 2015 Nov 7;386(10006):1853-60. doi: 10.1016/S0140-6736(15)00057-4. Epub 2015 Aug 30.
Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, De Bruyne B; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. J Am Coll Cardiol. 2010 Jul 13;56(3):177-84. doi: 10.1016/j.jacc.2010.04.012. Epub 2010 May 28.
Gotberg M, Cook CM, Sen S, Nijjer S, Escaned J, Davies JE. The Evolving Future of Instantaneous Wave-Free Ratio and Fractional Flow Reserve. J Am Coll Cardiol. 2017 Sep 12;70(11):1379-1402. doi: 10.1016/j.jacc.2017.07.770.
Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.
Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Botker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14):e009603. doi: 10.1161/JAHA.118.009603.
Xu B, Tu S, Qiao S, Qu X, Chen Y, Yang J, Guo L, Sun Z, Li Z, Tian F, Fang W, Chen J, Li W, Guan C, Holm NR, Wijns W, Hu S. Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3077-3087. doi: 10.1016/j.jacc.2017.10.035. Epub 2017 Oct 31.
Xu B, Tu S, Song L, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Fu X, Liu J, Zhao Y, Escaned J, Wang Y, Fearon WF, Dou K, Kirtane AJ, Wu Y, Serruys PW, Yang W, Wijns W, Guan C, Leon MB, Qiao S, Stone GW; FAVOR III China study group. Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial. Lancet. 2021 Dec 11;398(10317):2149-2159. doi: 10.1016/S0140-6736(21)02248-0. Epub 2021 Nov 4.
Masdjedi K, van Zandvoort LJC, Balbi MM, Gijsen FJH, Ligthart JMR, Rutten MCM, Lemmert ME, Wilschut JM, Diletti R, de Jaegere P, Zijlstra F, Van Mieghem NM, Daemen J. Validation of a three-dimensional quantitative coronary angiography-based software to calculate fractional flow reserve: the FAST study. EuroIntervention. 2020 Sep 18;16(7):591-599. doi: 10.4244/EIJ-D-19-00466.
Fearon WF, Achenbach S, Engstrom T, Assali A, Shlofmitz R, Jeremias A, Fournier S, Kirtane AJ, Kornowski R, Greenberg G, Jubeh R, Kolansky DM, McAndrew T, Dressler O, Maehara A, Matsumura M, Leon MB, De Bruyne B; FAST-FFR Study Investigators. Accuracy of Fractional Flow Reserve Derived From Coronary Angiography. Circulation. 2019 Jan 22;139(4):477-484. doi: 10.1161/CIRCULATIONAHA.118.037350.
Ki YJ, Hwang D, Yang S, Na SH, Doh JH, Nam CW, Kim DY, Choi BJ, Sohn CB, Lee HJ, Kim HK, Kim Y, Shin ES, Koo BK. Diagnostic Performance of Angiography-Derived FFR According to the Analysis Factors. Korean Circ J. 2025 Sep 3. doi: 10.4070/kcj.2025.0077. Online ahead of print.
Other Identifiers
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H-1903-013-1014
Identifier Type: -
Identifier Source: org_study_id
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