Coronary Artery DiseaseFAST IIINCT04931771
Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization
A study testing vFFR guided revascularization and FFR guided revascularization in people with Coronary Artery Disease, run by ECRI bv at 40 sites in 7 countries.
Trial summary
The FAST III is a randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial. A total of 2228 participants will be randomized in a 1:1 fashion to either vFFR- or FFR guided revascularization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- vFFR guided revascularization and FFR guided revascularization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,235 participants
- Where
- 40 sitesin 7 countries
- Study dates
- 9 Nov 2021to 17 Dec 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be ≥18 years of age
- Presenting with silent ischemia, stable angina, or non-ST-elevation acute coronary syndrome (NSTE-ACS)
- Coronary artery disease with at least one native artery in which the stenosis severity is questionable (typically 30-80% stenosis)
- FFR assessment and vFFR assessment feasible
- The patient is willing and able to cooperate with study procedures and follow-up until study completion
- Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she provides informed consent prior to any protocol-related procedure, as approved by the appropriate Ethics Committee
Who cannot join
- ST-elevation myocardial infarction (STEMI) at presentation
- Cardiogenic shock or severe hemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg) or use of left ventricular assist device
- Any target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow <3.
- Presence of thrombus in intermediate target lesion.
- Known untreated severe valvular heart disease
- Target lesion is located in or supplied by an arterial or venous bypass graft
Show all 14Show fewer
- History of cardiac allograft transplantation
- Aorto-ostial lesions with an estimated diameter stenosis >50%
- Severe tortuosity precluding the acquisitions of 2 orthogonal projections of the target vessel with minimal overlap or foreshortening.
- Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or adenosine
- Non-cardiac co-morbidities with a life expectancy less than 1 year
- Currently participating in another trial that is not yet at its primary endpoint. The patient is not allowed to participate in another investigational device or drug study until the trial primary endpoint time point is achieved and may only be enrolled once in the study
- Women of childbearing potential who do not have a negative pregnancy test within 24 hours before the procedure
- Subject belongs to a vulnerable population (per Investigator's judgment) or subject unable to read or write
Trial locations and contacts
40 sites in 7 countries.
40 sites in 7 countries
Italy8 sites
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo
AOU di Ferrara (Ospedale Sant'Anna)
Cona
Cardiologia Ospedale Dell' Angelo
Mestre
Humanitas Research Hospital
Milan
Policlinico San Donato
Milan
Pineta Grande Hospital
Naples
Ospedale Maggiore della Carità
Novara
Cardiologia Ospedale San Bortolo
Vicenza
Spain8 sites
Hospital Univeritario A Coruna
A Coruña
Hospital Clinic
Barcelona
Hospital del Mar
Barcelona
Hospital Universitario de Leon
León
Hospital Universitario de la Princesa
Madrid
La Paz
Madrid
Hospital Universitario Central de Asturias
Oviedo
Hospital Clinico Universitario de Valladolid
Valladolid
France7 sites
Clinique St Martin
Caen
Institut Cardiovasculaire de Grenoble
Grenoble
CHU LILLE - Institut Cœur Poumon
Lille
Hôpital de la Croix Rousse, hospices civils de lyon
Lyon
Hôpital Privé Jacques Cartier
Massy
Clinique les Fontaines
Melun
Clinique Saint Hilaire
Rouen
Germany6 sites
Herz- und Diabeteszentrum NRW
Bad Oeynhausen
Charité- Campus Benjamin Franklin
Berlin
Unfallkrankenhaus Berlin
Berlin
Universitatsklinikum Dusseldorf
Düsseldorf
Marienhaus Klinikum
Neuwied
SHG Klinik Völklingen
Völklingen
Netherlands5 sites
Tergooi MC
Blaricum
Amphia Ziekenhuis
Breda
Albert Schweitzer
Dordrecht
Erasmus University Medical Center
Rotterdam
UMCU
Utrecht
Ireland3 sites
Mater Private Cork
Cork
Mater Private Dublin
Dublin
St James Hospital
Dublin
United Kingdom3 sites
Royal Sussex County Hospital
Brighton
Golden Jubilee National Hospital
Glasgow
John Radcliffe Hospital
Oxford
About this study
The FAST III is a randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial. A total of 2228 participants will be randomized in a 1:1 fashion to either vFFR- or FFR guided revascularization. Patients will be consented prior to the procedure and then followed up to 12 (+1) months after randomization. The primary endpoint is analyzed at 12 months after randomization. Approximately 35 sites in 7 European countries (Netherlands, Ireland, United Kingdom, Germany, Italy, Spain, and France).
Read the detailed description
The FAST III is a randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial of a vFFR guided strategy as compared to a FFR guided strategy to guide coronary revascularization in 2228 subjects with intermediate coronary artery lesions.
Patients are screened for inclusion/exclusion criteria after the indication for coronary catheterization is established. After providing informed consent, patients are enrolled. Randomization is performed in the randomization module of the EDC system with an allocation ratio of 1:1 and stratification by center. The primary endpoint is a composite of all-cause death, any myocardial infarction, or any revascularization at 1 year post-randomization.
All deaths and major cardiovascular events, including the individual components of primary and secondary endpoints are adjudicated by an independent Clinical Events Committee (CEC), using standardized definitions. An independent Data and Safety Monitoring Board (DSMB) will formally review the accumulating data to ensure there is no avoidable increased risk for harm to participants. The FAST III trial is performed in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP), ISO 14155:2020, EC requirements and country specific regulations.
- Conditions
- Coronary Artery Disease
- Being tested
- vFFR guided revascularization, FFR guided revascularization
- Keywords
- Coronary artery disease, Intermediate coronary lesion, Coronary physiology, vFFR
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vFFR guided revascularizationDevice
3D-angio-based vessel FFR (CAAS, Pie Medical Imaging, Maastricht, The Netherlands) uses 3-Dimensional Quantitative Coronary Angiography (3D-QCA) for functional assessment of coronary stenosis. vFFR is calculated using two angiographic views with at least 30 degrees difference in rotation/angulation to generate the 3D reconstruction of the coronary artery.
FFR guided revascularizationDevice
Fractional flow reserve (FFR) is a technique used in coronary catheterization to measure pressure differences across a coronary artery stenosis (narrowing, usually due to atherosclerosis) to determine the likelihood that the stenosis impedes oxygen delivery to the heart muscle (myocardial ischemia)
| Study group | Role | What they receive |
|---|---|---|
| vFFR guided revascularization | Experimental | Not described Receives: Device: vFFR guided revascularization |
| FFR guided revascularization | Active comparator | Not described Receives: Device: FFR guided revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of the composite of all-cause death, any myocardial infarction, or any revascularization
Procedural myocardial infarction (MI) is adjudicated according to the ARC-2 consensus and spontaneous MI according to the 4th Universal definition of MI.
Measured: 1 year
Secondary outcomes (7)
Rate of patient-oriented composite endpoint (POCE) defined as all-cause death, any stroke, any myocardial infarction, and any revascularization
Measured: 1 year
Rate of device-oriented composite endpoint (DOCE) defined as the composite of cardiovascular death, target-vessel MI, clinically indicated repeat revascularization of the target lesion
Measured: 1 year
Rate of study-oriented composite endpoint (SOCE) defined as the composite of cardiovascular death, study-vessel or target vessel MI, or study-vessel or target vessel revascularization
Measured: 1 year
Rate of target-vessel failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization
Measured: 1 year
Rate of target-lesion failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-lesion revascularization
Measured: 1 year
Rate of study-vessel failure defined as a composite of cardiac death, study vessel myocardial infarction, or clinically indicated study-vessel revascularization
Measured: 1 year
Rate of definite and probable stent thrombosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start9 Nov 2021
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,235 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECRI bv
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Siemens Healthineers, Pie Medical Imaging
- Responsible party
- Sponsor
- Investigators
- Joost Daemen, MD, PhD, Principal investigator, Erasmus Medical CenterErnest Spitzer, MD, Study director, European Cardiovascular Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931771
- Sponsor's protocol ID
- ECRI-15
- Acronym
- FAST III
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2021
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daemen J, van der Eijk JA, Barbierato M, Byrne RA, Canova P, De Maria GL, Van Belle E, Amat-Santos I, Mangieri A, Hovasse T, Sabate M, Margey R, Biscaglia S, Rivero F, D'Amario D, Abdelwahed YS, Oemrawsingh RM, Moreno R, Cockburn J, Testa L, de Vries T, Landmesser U, Banning AP, Tijssen JGP, Spitzer E; FAST III Investigators. Angiography-Based Physiology to Guide Coronary Revascularization. N Engl J Med. 2026 Jul 2;395(1):20-31. doi: 10.1056/NEJMoa2601841. Epub 2026 Mar 29.
PubMed 41910382Scoccia A, Byrne RA, Banning AP, Landmesser U, Van Belle E, Amat-Santos IJ, Sabate M, Tijssen JGP, Spitzer E, Daemen J. Fractional flow reserve or 3D-quantitative-coronary-angiography based vessel-FFR guided revascularization. Rationale and study design of the prospective randomized fast III trial. Am Heart J. 2023 Jun;260:1-8. doi: 10.1016/j.ahj.2023.02.003. Epub 2023 Feb 14.
PubMed 36796573
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization
- ClinicalTrials.gov ID
- NCT04931771
- Acronym / sponsor ID
- FAST III / ECRI-15
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Intermediate coronary lesion, Coronary physiology, vFFR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,235 participants (actual)
- Lead sponsor
- ECRI bvIndustry (pharma, biotech, devices)
- Collaborators
- Siemens Healthineers, Pie Medical Imaging
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 18 Jun 2021 (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 FAST III is a randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial. A total of 2228 participants will be randomized in a 1:1 fashion to either vFFR- or FFR guided revascularization. Patients will be consented prior to the procedure and then followed up to 12 (+1) months after randomization. The primary endpoint is analyzed at 12 months after randomization. Approximately 35 sites in 7 European countries (Netherlands, Ireland, United Kingdom, Germany, Italy, Spain, and France).
Detailed description
The FAST III is a randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial of a vFFR guided strategy as compared to a FFR guided strategy to guide coronary revascularization in 2228 subjects with intermediate coronary artery lesions.
Patients are screened for inclusion/exclusion criteria after the indication for coronary catheterization is established. After providing informed consent, patients are enrolled. Randomization is performed in the randomization module of the EDC system with an allocation ratio of 1:1 and stratification by center. The primary endpoint is a composite of all-cause death, any myocardial infarction, or any revascularization at 1 year post-randomization.
All deaths and major cardiovascular events, including the individual components of primary and secondary endpoints are adjudicated by an independent Clinical Events Committee (CEC), using standardized definitions. An independent Data and Safety Monitoring Board (DSMB) will formally review the accumulating data to ensure there is no avoidable increased risk for harm to participants. The FAST III trial is performed in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP), ISO 14155:2020, EC requirements and country specific regulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vFFR guided revascularization | Experimental | Device: vFFR guided revascularization |
| FFR guided revascularization | Active comparator | Device: FFR guided revascularization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient must be ≥18 years of age
- Presenting with silent ischemia, stable angina, or non-ST-elevation acute coronary syndrome (NSTE-ACS)
- Coronary artery disease with at least one native artery in which the stenosis severity is questionable (typically 30-80% stenosis)
- FFR assessment and vFFR assessment feasible
- The patient is willing and able to cooperate with study procedures and follow-up until study completion
Key exclusion criteria (14 listed)
- ST-elevation myocardial infarction (STEMI) at presentation
- Cardiogenic shock or severe hemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg) or use of left ventricular assist device
- Any target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow <3.
- Presence of thrombus in intermediate target lesion.
- Known untreated severe valvular heart disease
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 |
|---|---|---|
| vFFR guided revascularization3D-angio-based vessel FFR (CAAS, Pie Medical Imaging, Maastricht, The Netherlands) uses 3-Dimensional Quantitative Coronary Angiography (3D-QCA) for functional assessment of coronary stenosis. vFFR is calculated using two angiographic views with at least 30 degrees difference in rotation/angulation to generate the 3D reconstruction of the coronary artery. | Device | vFFR guided revascularization |
| FFR guided revascularizationFractional flow reserve (FFR) is a technique used in coronary catheterization to measure pressure differences across a coronary artery stenosis (narrowing, usually due to atherosclerosis) to determine the likelihood that the stenosis impedes oxygen delivery to the heart muscle (myocardial ischemia) | Device | FFR guided revascularization |
Primary outcome
Rate of the composite of all-cause death, any myocardial infarction, or any revascularization
Time frame: 1 year
Procedural myocardial infarction (MI) is adjudicated according to the ARC-2 consensus and spontaneous MI according to the 4th Universal definition of MI.
7 secondary outcomes
Rate of patient-oriented composite endpoint (POCE) defined as all-cause death, any stroke, any myocardial infarction, and any revascularization
Time frame: 1 year
Rate of device-oriented composite endpoint (DOCE) defined as the composite of cardiovascular death, target-vessel MI, clinically indicated repeat revascularization of the target lesion
Time frame: 1 year
Rate of study-oriented composite endpoint (SOCE) defined as the composite of cardiovascular death, study-vessel or target vessel MI, or study-vessel or target vessel revascularization
Time frame: 1 year
Rate of target-vessel failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization
Time frame: 1 year
Rate of target-lesion failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-lesion revascularization
Time frame: 1 year
Rate of study-vessel failure defined as a composite of cardiac death, study vessel myocardial infarction, or clinically indicated study-vessel revascularization
Time frame: 1 year
Rate of definite and probable stent thrombosis
Time frame: 1 year
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 23 Jun 2026.
- Results publication: PubMed 41910382Daemen J, van der Eijk JA, Barbierato M, Byrne RA, Canova P, De Maria GL, Van Belle E, Amat-Santos I, Mangieri A, Hovasse T, Sabate M, Margey R, Biscaglia S, Rivero F, D'Amario D, Abdelwahed YS, Oemrawsingh RM, Moreno R, Cockburn J, Testa L, de Vries T, Landmesser U, Banning AP, Tijssen JGP, Spitzer E; FAST III Investigators. Angiography-Based Physiology to Guide Coronary Revascularization. N Engl J Med. 2026 Jul 2;395(1):20-31. doi: 10.1056/NEJMoa2601841. Epub 2026 Mar 29.
- Derived from this study: PubMed 36796573Scoccia A, Byrne RA, Banning AP, Landmesser U, Van Belle E, Amat-Santos IJ, Sabate M, Tijssen JGP, Spitzer E, Daemen J. Fractional flow reserve or 3D-quantitative-coronary-angiography based vessel-FFR guided revascularization. Rationale and study design of the prospective randomized fast III trial. Am Heart J. 2023 Jun;260:1-8. doi: 10.1016/j.ahj.2023.02.003. Epub 2023 Feb 14.
- 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.
Joost Daemen, MD, PhD principal investigator
Erasmus Medical Center
Ernest Spitzer, MD study director
European Cardiovascular Research Institute
40 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vFFR guided revascularization and FFR guided revascularization in people with Coronary Artery Disease, run by ECRI bv at 40 sites in 7 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 6 inclusion and 14 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Italy, Spain, France, Germany, Netherlands and 2 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?
Rate of the composite of all-cause death, any myocardial infarction, or any revascularization (time frame: 1 year). 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 NCT04931771, which also lists 2 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 23 Jun 2026.