Coronary Artery Disease Clinical Trial
— FLAVOUR IIIOfficial title:
Comparison of Fractional Flow Reserve-Guided Strategy Versus Intravascular Ultrasound-Guided Stent Implantation After Angiography-Derived Fractional Flow Reserve-based Decision-Making (The FLAVOUR III Trial)
To compare the clinical outcomes of fractional flow reserve (FFR)-guided strategy versus intravascular ultrasound (IVUS)-guided stent implantation after angiography-derived FFR-based decision-making.
Status | Not yet recruiting |
Enrollment | 1936 |
Est. completion date | December 1, 2029 |
Est. primary completion date | December 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Subject must be = 19 years. - Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI with a drug-eluting stent (DES) and he/she or his/her legally authorized representative provides written informed consent. - Subjects suspected with ischemic heart disease. - Subjects with coronary artery diameter stenosis 50-90% by angiography-based visual estimation eligible for stent implantation. - Target vessel size = 2.5mm in visual estimation. Exclusion Criteria: - Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor - Active pathologic bleeding. - Gastrointestinal or genitourinary major bleeding within the prior 3 months. - History of bleeding diathesis, known coagulopathy. - Non-cardiac co-morbid conditions with life expectancy < 2 years. - Target lesion located in coronary arterial bypass graft. - Left main coronary artery stenosis = 50%. - Chronic total occlusion in the study target vessel. - Culprit lesion of ST-elevation myocardial infarction (STEMI). - Not eligible for angiography-derived FFR (ostial RCA = 50% stenosis, severe tortuosity, severe overlap, poor image quality). |
Country | Name | City | State |
---|---|---|---|
China | Peking University Third Hospital | Beijing | |
China | Second Affiliated Hospital of Shantou University Medical College | Guangdong | |
China | The Affiliated Hospital of Hangzhou Normal University | Hangzhou | |
China | The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | |
China | Changxing People's Hospital | Huzhou | |
China | The Affiliated Hospital of Shandong University of TCM | Jinan | |
China | The Fourth People's Hospital of Jinan | Jinan | |
China | Jinhua Central Hospital | Jinhua | |
China | First Affiliated Hospital of Kunming Medical University | Kunming | |
China | The First Affiliated Hospital of Nanchang University | Nanchang | |
China | Ningbo Medical Center Lihuili Hospital | Ningbo | |
China | The Affiliated Hospital of Medical College, Ningbo University | Ningbo | |
China | Renji Hospital Shanghai Jiaotong University School of Medicine | Shanghai | |
China | The First Affiliated hospital of Wenzhou Medical University | Wenzhou | |
Korea, Republic of | Bucheon Sejong Hospital | Bucheon | |
Korea, Republic of | Inje University Haeundae Paik Hospital | Busan | |
Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
Korea, Republic of | Kyungpook National University Hospital | Daegu | |
Korea, Republic of | Chonnam National University Hospital | Donggu | |
Korea, Republic of | Inje University Ilsan Paik Hospital | Goyang | |
Korea, Republic of | Seoul National University Hospital, | Seoul | |
Korea, Republic of | Seoul ST. Mary's Hospital | Seoul | |
Korea, Republic of | Uijeongbu Eulji Medical Center | Uijeongbu | |
Korea, Republic of | Ulsan University Hospital | Ulsan | |
Korea, Republic of | Yonsei University Wonju Severance Hospital | Wonju |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University | Bucheon Sejong Hospital, Changxing People's Hospital, Chonnam National University Hospital, First Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Wenzhou Medical University, Inje University Haeundae Paik Hospital, Inje University Ilsan Paik Hospital, Jinhua Central Hospital, Keimyung University Dongsan Medical Center, Kyungpook National University Hospital, Ningbo Medical Center Lihuili Hospital, Peking University Third Hospital, RenJi Hospital, Second Affiliated Hospital of Shantou University Medical College, Seoul National University Hospital, Seoul St. Mary's Hospital, Shandong University of Traditional Chinese Medicine, The Affiliated Hospital of Hangzhou Normal University, The Affiliated Hospital of Medical College, Ningbo University, The First Affiliated Hospital of Nanchang University, The Fourth People's Hospital of Jinan, Uijeongbu Eulji Medical Center, Ulsan University Hospital, Yonsei University Wonju Severance Hospital |
China, Korea, Republic of,
Collet C, Onuma Y, Sonck J, Asano T, Vandeloo B, Kornowski R, Tu S, Westra J, Holm NR, Xu B, de Winter RJ, Tijssen JG, Miyazaki Y, Katagiri Y, Tenekecioglu E, Modolo R, Chichareon P, Cosyns B, Schoors D, Roosens B, Lochy S, Argacha JF, van Rosendael A, Bax J, Reiber JHC, Escaned J, De Bruyne B, Wijns W, Serruys PW. Diagnostic performance of angiography-derived fractional flow reserve: a systematic review and Bayesian meta-analysis. Eur Heart J. 2018 Sep 14;39(35):3314-3321. doi: 10.1093/eurheartj/ehy445. Erratum In: Eur Heart J. 2019 Jan 21;40(4):356. — View Citation
De Maria GL, Garcia-Garcia HM, Scarsini R, Hideo-Kajita A, Gonzalo Lopez N, Leone AM, Sarno G, Daemen J, Shlofmitz E, Jeremias A, Tebaldi M, Bezerra HG, Tu S, Lemos PA, Ozaki Y, Dan K, Collet C, Banning AP, Barbato E, Johnson NP, Waksman R. Novel Indices of Coronary Physiology: Do We Need Alternatives to Fractional Flow Reserve? Circ Cardiovasc Interv. 2020 Apr;13(4):e008487. doi: 10.1161/CIRCINTERVENTIONS.119.008487. Epub 2020 Apr 16. Erratum In: Circ Cardiovasc Interv. 2020 Jun;13(6):e000071. — View Citation
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. — View Citation
Gotberg M, Christiansen EH, Gudmundsdottir IJ, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Ohagen P, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Todt T, Venetsanos D, James SK, Karegren A, Nilsson M, Carlsson J, Hauer D, Jensen J, Karlsson AC, Panayi G, Erlinge D, Frobert O; iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823. doi: 10.1056/NEJMoa1616540. Epub 2017 Mar 18. — View Citation
Kogame N, Ono M, Kawashima H, Tomaniak M, Hara H, Leipsic J, Andreini D, Collet C, Patel MR, Tu S, Xu B, Bourantas CV, Lerman A, Piek JJ, Davies JE, Escaned J, Wijns W, Onuma Y, Serruys PW. The Impact of Coronary Physiology on Contemporary Clinical Decisi — View Citation
Koo BK, Hu X, Kang J, Zhang J, Jiang J, Hahn JY, Nam CW, Doh JH, Lee BK, Kim W, Huang J, Jiang F, Zhou H, Chen P, Tang L, Jiang W, Chen X, He W, Ahn SG, Yoon MH, Kim U, Lee JM, Hwang D, Ki YJ, Shin ES, Kim HS, Tahk SJ, Wang J; FLAVOUR Investigators. Fractional Flow Reserve or Intravascular Ultrasonography to Guide PCI. N Engl J Med. 2022 Sep 1;387(9):779-789. doi: 10.1056/NEJMoa2201546. — View Citation
Raber L, Mintz GS, Koskinas KC, Johnson TW, Holm NR, Onuma Y, Radu MD, Joner M, Yu B, Jia H, Meneveau N, de la Torre Hernandez JM, Escaned J, Hill J, Prati F, Colombo A, di Mario C, Regar E, Capodanno D, Wijns W, Byrne RA, Guagliumi G; ESC Scientific Document Group. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2018 Sep 14;39(35):3281-3300. doi: 10.1093/eurheartj/ehy285. Erratum In: Eur Heart J. 2019 Jan 14;40(3):308. — View Citation
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Writing Committee Members; Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient-oriented composite outcome | Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI), or any revascularization at 24 months after randomization. | 24 months | |
Secondary | Patient-oriented composite outcome at 60 months | Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI), or any revascularization. | 60 months | |
Secondary | Individual component of Patient-oriented composite outcome | Individual component of Patient-oriented composite outcome (death, myocardial infarction, revascularization). | 24 and 60 months | |
Secondary | Target vessel failure | Target vessel failure, defined as a composite of cardiac death, target-vessel MI, or target vessel revascularization. | 24 and 60 months | |
Secondary | Cost-effectiveness analysis | Incremental cost effectiveness ratio (ICER). | 24 and 60 months | |
Secondary | All-cause and cardiac death | All-cause and cardiac death. | 24 and 60 months | |
Secondary | Any nonfatal myocardial infarction without peri-procedural myocardial infarction | Any nonfatal myocardial infarction without peri-procedural myocardial infarction. | 24 and 60 months | |
Secondary | Any nonfatal myocardial infarction with peri-procedural myocardial infarction | Any nonfatal myocardial infarction with peri-procedural myocardial infarction. | 24 and 60 months | |
Secondary | Any target vessel/lesion revascularization | Any target vessel/lesion revascularization. | 24 and 60 months | |
Secondary | Any non-target vessel/lesion revascularization | Any non-target vessel/lesion revascularization. | 24 and 60 months | |
Secondary | Any revascularization (ischemia-driven or all) | Any revascularization (ischemia-driven or all). | 24 and 60 months | |
Secondary | Stent thrombosis (definite/probable/possible) | Stent thrombosis at 24 and 60 months after randomization. | 24 and 60 months | |
Secondary | Stroke (ischemic and hemorrhagic) | Stroke at 24 and 60 months after randomization. | 24 and 60 months |
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