search
Back to results

FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Stenting plus OMT
OMT
Standard of care
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Stable angina, angina pectoris, PCI, FAME, FAME II, FFR, Fractional Flow Reserve, Pressure wire

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with

    • 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:

  1. Patients in whom the preferred treatment is CABG
  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

Sites / Locations

  • VA Palo Alto
  • Stanford University Medical Center
  • Emory University
  • Atlanta VA Medical Center
  • Tulane University
  • Northeast Cardiology Associates
  • OLV Ziekenhuis
  • Centre Hospitalier de l'Universite de Montreal
  • Hopital du Sacre-Coeur de Montreal
  • Masaryk University and University Hospital Brno
  • Na Homolce Hospital
  • Rigshospitalet University Hospital
  • Hospices Civils de Lyon
  • Heart Center Leipzig
  • Klinikum der Universitat Munchen
  • Stadtisches Klinikum Munchen
  • Gottsegen Hungarian Institute of Cardiology
  • Azienda Ospedaliero Universitaria de Ferrara
  • Catharina-Ziekenhuis
  • St. Antonius Ziekenhuis
  • Isala Klinieken
  • Clinical Center Kragujevac
  • Orebro University Hospital
  • Sodersjukhuset AB
  • Royal Victoria Hospital
  • Edinburgh Heart Centre
  • Golden Jubilee National Hospital
  • Kings College Hospital
  • Southampton University Hospitals NHS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Cohort A: PCI plus OMT

Cohort A: OMT alone

Cohort B

Arm Description

PCI plus optimal medical treatment

Optimal medical treatment alone

FFR > 0.80; treatment according to local practice

Outcomes

Primary Outcome Measures

Major Adverse Cardiac Event Rate (MACE)
MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.

Secondary Outcome Measures

Overall MACE
Individual components of the primary end point, cardiac death, and nonurgent revascularization

Full Information

First Posted
May 20, 2010
Last Updated
August 8, 2019
Sponsor
Abbott Medical Devices
search

1. Study Identification

Unique Protocol Identification Number
NCT01132495
Brief Title
FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
Official Title
Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.
Detailed Description
Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Stable angina, angina pectoris, PCI, FAME, FAME II, FFR, Fractional Flow Reserve, Pressure wire

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: PCI plus OMT
Arm Type
Other
Arm Description
PCI plus optimal medical treatment
Arm Title
Cohort A: OMT alone
Arm Type
Other
Arm Description
Optimal medical treatment alone
Arm Title
Cohort B
Arm Type
Other
Arm Description
FFR > 0.80; treatment according to local practice
Intervention Type
Other
Intervention Name(s)
Stenting plus OMT
Intervention Description
FFR guided PCI, plus OMT
Intervention Type
Other
Intervention Name(s)
OMT
Intervention Description
OMT alone
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
FFR > 0.80; treatment according to local practice
Primary Outcome Measure Information:
Title
Major Adverse Cardiac Event Rate (MACE)
Description
MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.
Time Frame
24 Month
Secondary Outcome Measure Information:
Title
Overall MACE
Description
Individual components of the primary end point, cardiac death, and nonurgent revascularization
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with stable angina or, stabilized angina pectoris or, atypical chest pain or no chest pain but with documented silent ischemia at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium Eligible for PCI Signed written informed consent Exclusion Criteria: Patients in whom the preferred treatment is CABG Patients with left main coronary artery disease requiring revascularization Patients with a recent STEMI or Non-STEMI Prior CABG Contra-indication to dual antiplatelet therapy LVEF < 30% Severe LV hypertrophy Planned need for concomitant cardiac surgery Extremely tortuous or calcified coronary arteries precluding FFR measurements A life expectancy of less than 2 years Age under 21
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard De Bruyne, MD
Organizational Affiliation
O.L.Vrouwzlekenhuis Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Northeast Cardiology Associates
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
OLV Ziekenhuis
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Hopital du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Masaryk University and University Hospital Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Na Homolce Hospital
City
Praha
ZIP/Postal Code
150 16
Country
Czechia
Facility Name
Rigshospitalet University Hospital
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Heart Center Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Klinikum der Universitat Munchen
City
Munchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Stadtisches Klinikum Munchen
City
Munchen
ZIP/Postal Code
80337
Country
Germany
Facility Name
Gottsegen Hungarian Institute of Cardiology
City
Budapest
ZIP/Postal Code
1086
Country
Hungary
Facility Name
Azienda Ospedaliero Universitaria de Ferrara
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Catharina-Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Orebro University Hospital
City
Orebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Sodersjukhuset AB
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Facility Name
Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Edinburgh Heart Centre
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Golden Jubilee National Hospital
City
Glasgow
ZIP/Postal Code
G81 4HX
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Southampton University Hospitals NHS
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30354650
Citation
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.
Results Reference
derived
PubMed Identifier
29785878
Citation
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.
Results Reference
derived
PubMed Identifier
29162610
Citation
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. Erratum In: Circulation. 2018 May 29;137(22):e820.
Results Reference
derived
PubMed Identifier
29097450
Citation
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.
Results Reference
derived
PubMed Identifier
27884241
Citation
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.
Results Reference
derived
PubMed Identifier
25176289
Citation
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. Erratum In: N Engl J Med. 2014 Oct 9;371(15):1465.
Results Reference
derived
PubMed Identifier
23946263
Citation
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.
Results Reference
derived
PubMed Identifier
22924638
Citation
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. Erratum In: N Engl J Med. 2012 Nov;367(18):1768. Mobius-Winckler, Sven [corrected to Mobius-Winkler, Sven].
Results Reference
derived

Learn more about this trial

FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT

We'll reach out to this number within 24 hrs