Coronary Artery DiseaseNCT01132495

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

A study testing Stenting plus OMT and OMT in people with Coronary Artery Disease, run by Abbott Medical Devices at 29 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Stenting plus OMT and OMT
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,170 participants
Where: 29 sitesin 13 countries
Study dates: May 2010to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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%

Show all 11Show fewer

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

Trial locations and contacts

29 sites in 13 countries.

Country

City, postcode or hospital

29 sites in 13 countries

United States6 sites

Emory University
Atlanta, Georgia, 30322
Northeast Cardiology Associates
Bangor, Maine, 04401
Atlanta VA Medical Center
Decatur, Georgia, 30033
Tulane University
New Orleans, Louisiana, 70112
VA Palo Alto
Palo Alto, California, 94304
Stanford University Medical Center
Stanford, California, 94305

Other trials in United States

United Kingdom5 sites

Royal Victoria Hospital
Belfast, BT12 6BA
Edinburgh Heart Centre
Edinburgh, EH16 4SA
Golden Jubilee National Hospital
Glasgow, G81 4HX
Kings College Hospital
London, SE5 9RS
Southampton University Hospitals NHS
Southampton, SO16 6YD

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Germany3 sites

Heart Center Leipzig
Leipzig, 04289
Klinikum der Universitat Munchen
München, 80336
Stadtisches Klinikum Munchen
München, 80337

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Netherlands3 sites

Catharina-Ziekenhuis
Eindhoven
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
Isala Klinieken
Zwolle, 8011 JW

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Canada2 sites

Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2W 1T8
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5

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Czechia2 sites

Masaryk University and University Hospital Brno
Brno, 625 00
Na Homolce Hospital
Prague, 150 16

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Sweden2 sites

Orebro University Hospital
Örebro, 701 85
Sodersjukhuset AB
Stockholm, 11883

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Belgium1 site

OLV Ziekenhuis
Aalst, 9300

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Denmark1 site

Rigshospitalet University Hospital
Copenhagen, DK-2100

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France1 site

Hospices Civils de Lyon
Bron, 69677

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Hungary1 site

Gottsegen Hungarian Institute of Cardiology
Budapest, 1086

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Italy1 site

Azienda Ospedaliero Universitaria de Ferrara
Ferrara, 44100

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Serbia1 site

Clinical Center Kragujevac
Kragujevac, 34000

Other trials in Serbia

About this study

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

Read the detailed description

Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.

Conditions: Coronary Artery Disease
Being tested: Stenting plus OMT, OMT, Standard of care
Keywords: Stable angina, angina pectoris, PCI, FAME, FAME II, FFR, Fractional Flow Reserve, Pressure wire
Medical subject headings: Coronary Artery Disease, Angina, Stable, Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stenting plus OMTOther
FFR guided PCI, plus OMT
OMTOther
OMT alone
Standard of careOther
FFR > 0.80; treatment according to local practice

Study groups in NCT01132495
Study group	Role	What they receive
Cohort A: PCI plus OMT	Other	PCI plus optimal medical treatment Receives: Other: Stenting plus OMT
Cohort A: OMT alone	Other	Optimal medical treatment alone Receives: Other: OMT
Cohort B	Other	FFR > 0.80; treatment according to local practice Receives: Other: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

Major Adverse Cardiac Event Rate (MACE)
MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.
Measured: 24 Month

Secondary outcomes (1)

Overall MACE
Individual components of the primary end point, cardiac death, and nonurgent revascularization
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010May 2015

First posted28 May 2010 (estimated)
Study startMay 2010
Primary completionJan 2014
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01132495
Sponsor's protocol ID: 0904
Status last verified: Aug 2019
First submitted: 20 May 2010
Last updated: 16 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 30354650
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.
PubMed 29785878
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.
PubMed 29162610
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.
PubMed 29097450
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.
PubMed 27884241
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.
PubMed 25176289
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.
PubMed 23946263
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.
PubMed 22924638

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01132495
Acronym / sponsor ID: 0904
Conditions: Coronary Artery Disease
Keywords: Stable angina, angina pectoris, PCI, FAME, FAME II, FFR, Fractional Flow Reserve, Pressure wire
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,170 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Jan 2014 (actual)
Study completion: May 2015 (actual)
First posted: 28 May 2010 (estimated)
Results: Posted 9 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort A: PCI plus OMT	Other	Other: Stenting plus OMTPCI plus optimal medical treatment
Cohort A: OMT alone	Other	Other: OMTOptimal medical treatment alone
Cohort B	Other	Other: Standard of careFFR > 0.80; treatment according to local practice

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients with
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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stenting plus OMTFFR guided PCI, plus OMT	Other	Cohort A: PCI plus OMT
OMTOMT alone	Other	Cohort A: OMT alone
Standard of careFFR > 0.80; treatment according to local practice	Other	Cohort B

Primary outcome

Major Adverse Cardiac Event Rate (MACE)
Time frame: 24 Month
MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.

1 secondary outcome

Overall MACE
Time frame: 3 years

Results and safety

Results posted to the registry on 9 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A - PCI Plus OMT	447	407
Cohort A - OMT Alone	441	403
Cohort B - Follow-up	166	146
Cohort B - No Follow-up Re-consented	116	104

Primary outcome: Major Adverse Cardiac Event Rate (MACE)

Time frame: 24 Month. Number. Unit: percentage of subjects with SAEs

Measure	Cohort A - PCI Plus OMT n = 447	Cohort A - OMT Alone n = 441
Non Urgent Revascularization	6.7	32.7
Death or Myocardial Infarction	9.4	12.2
Myocardial Infarction	6.7	9.3
Unplanned Hospitalizations with urgent revasc	1.8	13.4
Death	3.6	3.9
Cerebrovascular Event	2.2	1.4
Other Serious Adverse Event (SAE)	0.2	0.7

Population analysed: The primary outcome analysis was designed for Cohort A only.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A - PCI Plus OMT	137 of 447 (30.6%)	0 of 0	Not reported
Cohort A - OMT Alone	324 of 441 (73.5%)	0 of 0	Not reported
Cohort B - Follow-up	55 of 166 (33.1%)	0 of 0	Not reported
Cohort B - No Follow-up Re-consented	28 of 116 (24.1%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30354650Nishi 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.
Derived from this study: PubMed 29785878Xaplanteris 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.
Derived from this study: PubMed 29162610Ciccarelli 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.
Derived from this study: PubMed 29097450Fearon 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.
Derived from this study: PubMed 27884241Barbato 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.
Derived from this study: PubMed 25176289De 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.
Derived from this study: PubMed 23946263Fearon 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.
Derived from this study: PubMed 22924638De 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bernard De Bruyne, MD principal investigator

O.L.Vrouwzlekenhuis Hospital

29 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Stenting plus OMT and OMT in people with Coronary Artery Disease, run by Abbott Medical Devices at 29 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, United Kingdom, Germany, Netherlands, Canada and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiac Event Rate (MACE) (time frame: 24 Month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01132495, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.