FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
NCT ID: NCT01132495
Last Updated: 2019-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1170 participants
INTERVENTIONAL
2010-05-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cohort A: PCI plus OMT
PCI plus optimal medical treatment
Stenting plus OMT
FFR guided PCI, plus OMT
Cohort A: OMT alone
Optimal medical treatment alone
OMT
OMT alone
Cohort B
FFR \> 0.80; treatment according to local practice
Standard of care
FFR \> 0.80; treatment according to local practice
Interventions
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Stenting plus OMT
FFR guided PCI, plus OMT
OMT
OMT alone
Standard of care
FFR \> 0.80; treatment according to local practice
Eligibility Criteria
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Inclusion Criteria
* stable angina or,
* stabilized angina pectoris or,
* atypical chest pain or no chest pain but with documented silent ischemia
2. at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium
3. Eligible for PCI
4. Signed written informed consent
Exclusion Criteria
2. Patients with left main coronary artery disease requiring revascularization
3. Patients with a recent STEMI or Non-STEMI
4. Prior CABG
5. Contra-indication to dual antiplatelet therapy
6. LVEF \< 30%
7. Severe LV hypertrophy
8. Planned need for concomitant cardiac surgery
9. Extremely tortuous or calcified coronary arteries precluding FFR measurements
10. A life expectancy of less than 2 years
11. Age under 21
21 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Bernard De Bruyne, MD
Role: PRINCIPAL_INVESTIGATOR
O.L.Vrouwzlekenhuis Hospital
Locations
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VA Palo Alto
Palo Alto, California, United States
Stanford University Medical Center
Stanford, California, United States
Emory University
Atlanta, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Tulane University
New Orleans, Louisiana, United States
Northeast Cardiology Associates
Bangor, Maine, United States
OLV Ziekenhuis
Aalst, , Belgium
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Masaryk University and University Hospital Brno
Brno, , Czechia
Na Homolce Hospital
Prague, , Czechia
Rigshospitalet University Hospital
Copenhagen, , Denmark
Hospices Civils de Lyon
Bron, , France
Heart Center Leipzig
Leipzig, , Germany
Klinikum der Universitat Munchen
München, , Germany
Stadtisches Klinikum Munchen
München, , Germany
Gottsegen Hungarian Institute of Cardiology
Budapest, , Hungary
Azienda Ospedaliero Universitaria de Ferrara
Ferrara, , Italy
Catharina-Ziekenhuis
Eindhoven, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Clinical Center Kragujevac
Kragujevac, , Serbia
Orebro University Hospital
Örebro, , Sweden
Sodersjukhuset AB
Stockholm, , Sweden
Royal Victoria Hospital
Belfast, , United Kingdom
Edinburgh Heart Centre
Edinburgh, , United Kingdom
Golden Jubilee National Hospital
Glasgow, , United Kingdom
Kings College Hospital
London, , United Kingdom
Southampton University Hospitals NHS
Southampton, , United Kingdom
Countries
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References
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Nishi T, Piroth Z, De Bruyne B, Jagic N, Mobius-Winkler S, Kobayashi Y, Derimay F, Fournier S, Barbato E, Tonino P, Juni P, Pijls NHJ, Fearon WF. Fractional Flow Reserve and Quality-of-Life Improvement After Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease. Circulation. 2018 Oct 23;138(17):1797-1804. doi: 10.1161/CIRCULATIONAHA.118.035263.
Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, Engstrom T, Kaab S, Dambrink JH, Rioufol G, Toth GG, Piroth Z, Witt N, Frobert O, Kala P, Linke A, Jagic N, Mates M, Mavromatis K, Samady H, Irimpen A, Oldroyd K, Campo G, Rothenbuhler M, Juni P, De Bruyne B; FAME 2 Investigators. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med. 2018 Jul 19;379(3):250-259. doi: 10.1056/NEJMoa1803538. Epub 2018 May 22.
Ciccarelli G, Barbato E, Toth GG, Gahl B, Xaplanteris P, Fournier S, Milkas A, Bartunek J, Vanderheyden M, Pijls N, Tonino P, Fearon WF, Juni P, De Bruyne B. Angiography Versus Hemodynamics to Predict the Natural History of Coronary Stenoses: Fractional Flow Reserve Versus Angiography in Multivessel Evaluation 2 Substudy. Circulation. 2018 Apr 3;137(14):1475-1485. doi: 10.1161/CIRCULATIONAHA.117.028782. Epub 2017 Nov 21.
Fearon WF, Nishi T, De Bruyne B, Boothroyd DB, Barbato E, Tonino P, Juni P, Pijls NHJ, Hlatky MA; FAME 2 Trial Investigators. Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease: Three-Year Follow-Up of the FAME 2 Trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation). Circulation. 2018 Jan 30;137(5):480-487. doi: 10.1161/CIRCULATIONAHA.117.031907. Epub 2017 Nov 2.
Barbato E, Toth GG, Johnson NP, Pijls NH, Fearon WF, Tonino PA, Curzen N, Piroth Z, Rioufol G, Juni P, De Bruyne B. A Prospective Natural History Study of Coronary Atherosclerosis Using Fractional Flow Reserve. J Am Coll Cardiol. 2016 Nov 29;68(21):2247-2255. doi: 10.1016/j.jacc.2016.08.055.
De Bruyne B, Fearon WF, Pijls NH, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nuesch E, Juni P; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014 Sep 25;371(13):1208-17. doi: 10.1056/NEJMoa1408758. Epub 2014 Sep 1.
Fearon WF, Shilane D, Pijls NH, Boothroyd DB, Tonino PA, Barbato E, Juni P, De Bruyne B, Hlatky MA; Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 2 (FAME 2) Investigators. Cost-effectiveness of percutaneous coronary intervention in patients with stable coronary artery disease and abnormal fractional flow reserve. Circulation. 2013 Sep 17;128(12):1335-40. doi: 10.1161/CIRCULATIONAHA.113.003059. Epub 2013 Aug 14.
De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.
Other Identifiers
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0904
Identifier Type: -
Identifier Source: org_study_id
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