Coronary Artery DiseaseFAME2-10yFUNCT06159231
FAME II-10-year Follow-Up
An observational study of Coronary Artery Disease, run by CoreAalst BV at 16 sites in 11 countries.
Trial summary
The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design. The overall purpose of the FAME-II trial was to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 888 participants
- Where
- 16 sitesin 11 countries
- Study dates
- 25 Apr 2023to 15 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients that were enrolled in the original FAME2 study, i.e. consecutive patients with stable clinical condition and angiographically defined one-, two, or three-vessel coronary artery disease and amenable for PCI
Who may be able to join
- Patients with
- stable angina pectoris (Canadian Cardiovascular Society Class [CCS] 1, 2, 3)
- or, angina pectoris CCS class 4 subsequently stabilized medically (minimum 7 days) or,
- atypical chest pain or no chest pain but with documented silent ischemia on non-invasive testing.
- In whom at least one stenosis was present of at least 50% in one major native epicardial coronary artery with a diameter of at least 2.5 mm and supplying viable myocardium
- Eligible for PCI
- Signed written informed consent was obtained. Patients will have to sign a specific informed consent for the present 10-year follow-up.
Who cannot join
- Patients in whom the preferred treatment is CABG
- Patients with left main coronary artery disease requiring revascularization
- Patients with a recent (less than 1 WEEK) STEMI or Non-STEMI
- Prior CABG
- Contra-indication to dual antiplatelet therapy
- LVEF < 30%
Show all 15Show fewer
- Severe LV hypertrophy (defined as a septal wall thickness at echocardiography of more than 13 mm)
- Planned need for concomitant cardiac surgery (e.g., valve surgery or resection of aortic or left ventricular aneurysm etc.)
- Extremely tortuous or calcified coronary arteries precluding FFR measurements
- A life expectancy of less than 2 years
- Age under 21
- Pregnancy or intention to become pregnant during the course of the trial
- Refusal or inability to sign an informed consent. Mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the trial or mental retardation or language barrier such that the patient is unable to give informed consent
- Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits
- Participation or planned participation in another cardiovascular clinical trial before two year follow-up is completed
Trial locations and contacts
16 sites in 11 countries.
16 sites in 11 countries
United States3 sites
Northern Light Eastern Maine Medical Center
Bangor, Maine, 04401
Atlanta VA Medical Center
Decatur, Georgia, 30033
Stanford University Medical Center
Stanford, California, 94305
Czechia2 sites
Masaryk University - Dept. of Internal Cardiology Medicine
Brno, Moravia, 601 77
Nemocnice Na Homolce
Prague, 150 00
Germany2 sites
Universität Leipzig Herzzentrum
Leipzig, Saxony, 04289
München Klinikum Innenstadt
München, 80336
Sweden2 sites
Universitestssjukhuset i Örebro
Örebro, Örebro County, 701 85
Sodersjukhuset
Stockholm, Stockholm County, 118 83
France1 site
Hopital Cardiovasculaire et Pneumologique Louis Pradel
Bron, Lyon, 69500
Hungary1 site
Gottsegen Hungarian Institute of Cardiology
Budapest, Budapest, 1096
Italy1 site
Azienda Ospedaliera Universitaria S. Anna (Ferrara)
Cona, Ferrara, 44124
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 - FAME II, a 10-year Follow-up Study.
The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design.
The overall purpose of the FAME-II trial was 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 and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence.
Read more
FAME-II was conducted from 2009 to 2012 and 1-year, 2-year and 5-year results have been published.
The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization).
Patients will have to sign a specific informed consent for the present 10-year follow-up.
This study will be conducted for about approximately 6 months.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of major adverse cardiac events after 10 years of follow-up
10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization).
Measured: 10 years
Secondary outcomes (3)
Comparison of the rate of all-cause death between randomization arms (of the original FAME2 study).
Comparison of the rate of all-cause death between randomization arms (of the original FAME2 study).
Measured: 10 years
Comparison of the rate of documented myocardial infarction between randomization arms (of the original FAME2 study).
Comparison of the rate of documented myocardial infarction between randomization arms (of the original FAME2 study).
Measured: 10 years
Comparison of the rate of unplanned hospitalization leading to urgent revascularization between randomization arms (of the original FAME2 study).
Comparison of the rate of unplanned hospitalization leading to urgent revascularization between randomization arms (of the original FAME2 study).
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start25 Apr 2023
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 888 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoreAalst BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159231
- Sponsor's protocol ID
- CRI-086
- Acronym
- FAME2-10yFU
- Status last verified
- Jan 2025
- First submitted
- 30 Mar 2023
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Collet C, Mahendiran T, Fearon WF, Mizukami T, Munhoz D, Pijls NHJ, Tonino PAL, Barbato E, Piroth Z, Sreckovic M, Thiele H, El Farissi M, Witt N, Rioufol G, Kala P, Engstrom T, Mavromatis K, Frobert O, Verlee P, Brunner S, Mates M, Jagic N, Campo G, Pardaens S, Ikeda K, Pereira TV, da Costa BR, Fournier S, De Bruyne B, Juni P. Fractional flow reserve-guided percutaneous coronary intervention versus medical therapy for stable coronary artery disease: long-term results of the FAME 2 trial. Nat Med. 2026 Jan;32(1):318-324. doi: 10.1038/s41591-025-04132-5. Epub 2026 Jan 15.
PubMed 41540107
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. 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 - FAME II, a 10-year Follow-up Study.
- ClinicalTrials.gov ID
- NCT06159231
- Acronym / sponsor ID
- FAME2-10yFU / CRI-086
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 888 participants (actual)
- Lead sponsor
- CoreAalst BVIndustry (pharma, biotech, devices)
- Collaborators
- Abbott Medical Devices
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design.
The overall purpose of the FAME-II trial was 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 and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence.
FAME-II was conducted from 2009 to 2012 and 1-year, 2-year and 5-year results have been published.
The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization).
Patients will have to sign a specific informed consent for the present 10-year follow-up.
This study will be conducted for about approximately 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that were enrolled in the original FAME2 study, i.e. consecutive patients with stable clinical condition and angiographically defined one-, two, or three-vessel coronary artery disease and amenable for PCI
Key inclusion criteria (7 listed)
- Patients with
- In whom at least one stenosis was present of at least 50% in one major native epicardial coronary artery with a diameter of at least 2.5 mm and supplying viable myocardium
- Eligible for PCI
- Signed written informed consent was obtained. Patients will have to sign a specific informed consent for the present 10-year follow-up.
Key exclusion criteria (15 listed)
- Patients in whom the preferred treatment is CABG
- Patients with left main coronary artery disease requiring revascularization
- Patients with a recent (less than 1 WEEK) 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.
Primary outcome
The rate of major adverse cardiac events after 10 years of follow-up
Time frame: 10 years
10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization).
3 secondary outcomes
Comparison of the rate of all-cause death between randomization arms (of the original FAME2 study).
Time frame: 10 years
Comparison of the rate of documented myocardial infarction between randomization arms (of the original FAME2 study).
Time frame: 10 years
Comparison of the rate of unplanned hospitalization leading to urgent revascularization between randomization arms (of the original FAME2 study).
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Derived from this study: PubMed 41540107Collet C, Mahendiran T, Fearon WF, Mizukami T, Munhoz D, Pijls NHJ, Tonino PAL, Barbato E, Piroth Z, Sreckovic M, Thiele H, El Farissi M, Witt N, Rioufol G, Kala P, Engstrom T, Mavromatis K, Frobert O, Verlee P, Brunner S, Mates M, Jagic N, Campo G, Pardaens S, Ikeda K, Pereira TV, da Costa BR, Fournier S, De Bruyne B, Juni P. Fractional flow reserve-guided percutaneous coronary intervention versus medical therapy for stable coronary artery disease: long-term results of the FAME 2 trial. Nat Med. 2026 Jan;32(1):318-324. doi: 10.1038/s41591-025-04132-5. Epub 2026 Jan 15.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by CoreAalst BV at 16 sites in 11 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 15 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 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Czechia, Germany, Sweden, Belgium and 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The rate of major adverse cardiac events after 10 years of follow-up (time frame: 10 years). 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 NCT06159231, which also lists 1 linked publication.
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 7 Jan 2025.