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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02100722
Registration number
NCT02100722
Ethics application status
Date submitted
21/03/2014
Date registered
1/04/2014
Date last updated
18/04/2024
Titles & IDs
Public title
A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
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Scientific title
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Trial A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
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Secondary ID [1]
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FAME 3
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Universal Trial Number (UTN)
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Trial acronym
FAME 3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Disease
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Coronary Stenosis
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - CABG
Treatment: Devices - Resolute Integrity Stent
Treatment: Devices - Resolute Onyx Stent
Active comparator: FFR guided PCI - Patients undergoing PCI will have FFR measured with a St. Jude Medical coronary pressure wire across all lesions. If the FFR is =0.80, then PCI will be performed with the Medtronic Resolute Integrity (or Onyx) drug-eluting stent (DES) as per usual routine. If the FFR is \>0.80 then PCI will be deferred. Only those sites with prior experience measuring FFR will be included in the FAME 3 trial. These patients in whom FFR of a particular lesion was not possible will be included in all analyses based on the intention to treat principle.
Active comparator: CABG - CABG will be performed as per clinical routine at each participating center. Both off-pump and on-pump surgery are acceptable, as long as the surgeon and the site are experienced in the particular technique. An internal mammary graft to the LAD should be attempted in all cases, if feasible. Complete arterial revascularization is strongly recommended, however, each center should use a conduit strategy with which they are most comfortable. All vessels = 1,5 mm in diameter and with = 50% stenosis should be bypassed, if technically feasible.
Treatment: Surgery: CABG
Coronary Artery Bypass Graft Surgery (CABG)
Treatment: Devices: Resolute Integrity Stent
Durable polymer zotarolimus-eluting stent
Treatment: Devices: Resolute Onyx Stent
Durable polymer zotarolimus-eluting stent
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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MACCE
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Assessment method [1]
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Death, MI, stroke and any repeat revascularization (MACCE) will be evaluated at 1 year, where subjects contribute data from time of randomization until the occurrence of MACCE or one year follow-up, whichever occurs first. Subjects who die or are lost to follow up before 1 year will be censored at their last recorded activity.
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Timepoint [1]
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1 year
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Secondary outcome [1]
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Key Secondary Outcome: Composite of Death From Any Cause, Myocardial Infarction, or Stroke
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Assessment method [1]
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Death, MI, or stroke at 3-year follow-up
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Timepoint [1]
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3 years
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Secondary outcome [2]
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Number of Participants Experiencing Death, MI, or Stroke
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Assessment method [2]
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Subjects who died or are lost to follow up before this time were censored at their last recorded activity.
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Timepoint [2]
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1 year
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Secondary outcome [3]
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Death
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Assessment method [3]
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Death evaluated excluding patients lost to follow-up from each arm
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Timepoint [3]
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1 year
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Secondary outcome [4]
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Number of Participants Experiencing Myocardial Infarction
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Assessment method [4]
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MI evaluated excluding patients lost to follow-up from each arm
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Timepoint [4]
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1 year
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Secondary outcome [5]
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Number of Participants Experiencing Stroke
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Assessment method [5]
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Stroke evaluated excluding patients lost to follow-up from each arm.
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Timepoint [5]
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1 year
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Secondary outcome [6]
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Number of Participants Requiring Repeat Revascularization
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Assessment method [6]
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Any repeat revascularization evaluated excluding patients lost to follow-up from each arm
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Timepoint [6]
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1 year
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Secondary outcome [7]
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Number of Participants Experiencing BARC Type 3-5 Bleeding
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Assessment method [7]
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Bleeding Academic Research Consortium (BARC) type 3-5 indicates severe bleeding.
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1 year
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Secondary outcome [8]
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Number of Participants Experiencing Acute Kidney Injury
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Assessment method [8]
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1 year
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Secondary outcome [9]
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Number of Participants Experiencing Atrial Fibrillation or Clinically Significant Arrhythmia
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Assessment method [9]
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1 year
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Secondary outcome [10]
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Number of Participants Experiencing Definite Stent Thrombosis
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Assessment method [10]
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Timepoint [10]
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1 year
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Secondary outcome [11]
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Number of Participants Experiencing Definite Symptomatic Graft Occlusion
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Assessment method [11]
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1 year
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Secondary outcome [12]
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Number of Participants Requiring Rehospitalization Within 30 Days
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Assessment method [12]
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Timepoint [12]
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30 days
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Secondary outcome [13]
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MACCE
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Assessment method [13]
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Death, MI, stroke and any repeat revascularization (MACCE) rate at 2 years, 3 years and 5 years
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Timepoint [13]
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2 years, 3 years, 5 years
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Secondary outcome [14]
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Death, MI, or Stroke at 5 Years
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Assessment method [14]
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Death, MI, or stroke at 5 years
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Timepoint [14]
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5 years
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Secondary outcome [15]
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Individual Components of Primary Outcome
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Assessment method [15]
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Individual components of primary outcome: number of participants experiencing death, myocardial infarction, and stroke
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Timepoint [15]
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At year 3
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Eligibility
Key inclusion criteria
* 1. Age = 21 years with angina and/or evidence of myocardial ischemia
* 2. Three vessel CAD, defined as = 50% diameter stenosis by visual estimation in each of the three major epicardial vessels or major side branches, but not involving left main coronary artery, and amenable to revascularization by both PCI and CABG as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if only the left anterior descending artery (LAD) and left circumflex have =50% stenosis
* 3. Willing and able to provide informed, written consent
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 1. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, carotid revascularization)
* 2. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
* 3. Recent STEMI (<5 days prior to randomization)
* 4. Ongoing Non STEMI with biomarkers (cardiac troponin) still rising
* 5. Known left ventricular ejection fraction <30%
* 6. Life expectancy < 2 years
* 7. Requiring renal replacement therapy
* 8. Undergoing evaluation for organ transplantation
* 9. Participation or planned participation in another clinical trial, except for observational registries
* 10. Pregnancy
* 11. Inability to take dual antiplatelet therapy for six months
* 12. Previous CABG
* 13. Left main disease requiring revascularization
* 14. Extremely calcified or tortuous vessels precluding FFR measurement
* 15. Any target lesion with in-stent drug-eluting stent restenosis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/08/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
1500
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Peninsula Health - Frankston
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St. Vincent's Hospital Melbourne - Melbourne
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Concord Hospital - Sydney
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Royal North Shore - Sydney
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University of Sydney - Sydney
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- Frankston
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- Melbourne
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- Sydney
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Belgium
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Aalst
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Canada
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Montreal
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Canada
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Ontario
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Canada
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Ottawa
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Czechia
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France
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Lyon
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Hungary
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Seoul
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Vilnius
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Eindhoven
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Netherlands
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The Hague
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Zwolle
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New Zealand
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Hamilton
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Stavanger
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Goteborg
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Sweden
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Stockholm
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United Kingdom
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Cardiff
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Coventry And Warwickshire
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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Manchester
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Oxford
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United Kingdom
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Southhampton
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Funding & Sponsors
Primary sponsor type
Other
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Name
Stanford University
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Address
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Other collaborator category [1]
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Other
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Name [1]
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VZW Cardiovascular Research Center Aalst
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Other
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Catharina Ziekenhuis Eindhoven
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Government body
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Golden Jubilee National Hospital
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Other
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University of California, Irvine
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Commercial sector/industry
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Medtronic
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Commercial sector/industry
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Abbott Medical Devices
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Commercial sector/industry
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Genae
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Other
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King's College Hospital, London
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Other
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Houston Methodist DeBakey Heart and Vascular Center, Houston
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG).
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Trial website
https://clinicaltrials.gov/study/NCT02100722
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Trial related presentations / publications
Zimmermann FM, De Bruyne B, Pijls NH, Desai M, Oldroyd KG, Park SJ, Reardon MJ, Wendler O, Woo J, Yeung AC, Fearon WF. Rationale and design of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 Trial: a comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease. Am Heart J. 2015 Oct;170(4):619-626.e2. doi: 10.1016/j.ahj.2015.06.024. Epub 2015 Jul 9. Zimmermann FM, De Bruyne B, Pijls NHJ, Desai M, Oldroyd KG, Reardon MJ, Wendler O, Woo J, Yeung AC, Fearon WF. A protocol update of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 trial: A comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease. Am Heart J. 2019 Aug;214:156-157. doi: 10.1016/j.ahj.2019.04.012. Epub 2019 Apr 29. No abstract available. Fearon WF, Zimmermann FM, De Bruyne B, Piroth Z, van Straten AHM, Szekely L, Davidavicius G, Kalinauskas G, Mansour S, Kharbanda R, Ostlund-Papadogeorgos N, Aminian A, Oldroyd KG, Al-Attar N, Jagic N, Dambrink JE, Kala P, Angeras O, MacCarthy P, Wendler O, Casselman F, Witt N, Mavromatis K, Miner SES, Sarma J, Engstrom T, Christiansen EH, Tonino PAL, Reardon MJ, Lu D, Ding VY, Kobayashi Y, Hlatky MA, Mahaffey KW, Desai M, Woo YJ, Yeung AC, Pijls NHJ; FAME 3 Investigators. Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery. N Engl J Med. 2022 Jan 13;386(2):128-137. doi: 10.1056/NEJMoa2112299. Epub 2021 Nov 4. Piroth Z, Otsuki H, Zimmermann FM, Ferenci T, Keulards DCJ, Yeung AC, Pijls NHJ, De Bruyne B, Fearon WF. Prognostic Value of Measuring Fractional Flow Reserve After Percutaneous Coronary Intervention in Patients With Complex Coronary Artery Disease: Insights From the FAME 3 Trial. Circ Cardiovasc Interv. 2022 Nov;15(11):884-891. doi: 10.1161/CIRCINTERVENTIONS.122.012542. Epub 2022 Sep 19. Fearon WF, Zimmermann FM, Ding VY, Zelis JM, Piroth Z, Davidavicius G, Mansour S, Kharbanda R, Ostlund-Papadogeorgos N, Oldroyd KG, Wendler O, Reardon MJ, Woo YJ, Yeung AC, Pijls NHJ, De Bruyne B, Desai M, Hlatky MA; FAME 3 Investigators. Quality of Life After Fractional Flow Reserve-Guided PCI Compared With Coronary Bypass Surgery. Circulation. 2022 May 31;145(22):1655-1662. doi: 10.1161/CIRCULATIONAHA.122.060049. Epub 2022 Apr 2.
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Public notes
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Contacts
Principal investigator
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William F Fearon, MD
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Address
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Stanford University
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/22/NCT02100722/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/22/NCT02100722/Prot_SAP_000.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Fearon WF, Zimmermann FM, De Bruyne B, Piroth Z, v...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT02100722
Download to PDF