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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
FAME 3
Universal Trial Number (UTN)
Trial acronym
FAME 3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Disease 0 0
Coronary Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - FFR guided PCI
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: FFR guided PCI


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
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
MACCE
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Key Secondary Outcome: Composite of Death From Any Cause, Myocardial Infarction, or Stroke
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Number of Participants Experiencing Death, MI, or Stroke
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Death
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Number of Participants Experiencing Myocardial Infarction
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
Number of Participants Experiencing Stroke
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
Number of Participants Requiring Repeat Revascularization
Timepoint [6] 0 0
1 year
Secondary outcome [7] 0 0
Number of Participants Experiencing BARC Type 3-5 Bleeding
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
Number of Participants Experiencing Acute Kidney Injury
Timepoint [8] 0 0
1 year
Secondary outcome [9] 0 0
Number of Participants Experiencing Atrial Fibrillation or Clinically Significant Arrhythmia
Timepoint [9] 0 0
1 year
Secondary outcome [10] 0 0
Number of Participants Experiencing Definite Stent Thrombosis
Timepoint [10] 0 0
1 year
Secondary outcome [11] 0 0
Number of Participants Experiencing Definite Symptomatic Graft Occlusion
Timepoint [11] 0 0
1 year
Secondary outcome [12] 0 0
Number of Participants Requiring Rehospitalization Within 30 Days
Timepoint [12] 0 0
30 days
Secondary outcome [13] 0 0
MACCE
Timepoint [13] 0 0
2 years, 3 years, 5 years
Secondary outcome [14] 0 0
Death, MI, or Stroke at 5 Years
Timepoint [14] 0 0
5 years
Secondary outcome [15] 0 0
Individual Components of Primary Outcome
Timepoint [15] 0 0
At year 3

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
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
1500
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peninsula Health - Frankston
Recruitment hospital [2] 0 0
St. Vincent's Hospital Melbourne - Melbourne
Recruitment hospital [3] 0 0
Concord Hospital - Sydney
Recruitment hospital [4] 0 0
Royal North Shore - Sydney
Recruitment hospital [5] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- Frankston
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Belgium
State/province [12] 0 0
Aalst
Country [13] 0 0
Canada
State/province [13] 0 0
Montreal
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Ottawa
Country [16] 0 0
Czechia
State/province [16] 0 0
Brno
Country [17] 0 0
Denmark
State/province [17] 0 0
Copenhagen
Country [18] 0 0
France
State/province [18] 0 0
Lyon
Country [19] 0 0
Hungary
State/province [19] 0 0
Budapest
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul
Country [21] 0 0
Lithuania
State/province [21] 0 0
Vilnius
Country [22] 0 0
Netherlands
State/province [22] 0 0
Eindhoven
Country [23] 0 0
Netherlands
State/province [23] 0 0
The Hague
Country [24] 0 0
Netherlands
State/province [24] 0 0
Zwolle
Country [25] 0 0
New Zealand
State/province [25] 0 0
Hamilton
Country [26] 0 0
Norway
State/province [26] 0 0
Stavanger
Country [27] 0 0
Serbia
State/province [27] 0 0
Belgrade
Country [28] 0 0
Serbia
State/province [28] 0 0
Kragujevac
Country [29] 0 0
Sweden
State/province [29] 0 0
Goteborg
Country [30] 0 0
Sweden
State/province [30] 0 0
Stockholm
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Cardiff
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Coventry And Warwickshire
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Glasgow
Country [34] 0 0
United Kingdom
State/province [34] 0 0
London
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Manchester
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Oxford
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Southhampton

Funding & Sponsors
Primary sponsor type
Other
Name
Stanford University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
VZW Cardiovascular Research Center Aalst
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Catharina Ziekenhuis Eindhoven
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Golden Jubilee National Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of California, Irvine
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Commercial sector/Industry
Name [5] 0 0
Medtronic
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Commercial sector/Industry
Name [6] 0 0
Abbott Medical Devices
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Commercial sector/Industry
Name [7] 0 0
Genae
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
King's College Hospital, London
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Houston Methodist DeBakey Heart and Vascular Center, Houston
Address [9] 0 0
Country [9] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02100722
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.
Public notes

Contacts
Principal investigator
Name 0 0
William F Fearon, MD
Address 0 0
Stanford University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02100722