Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization
NCT ID: NCT04931771
Last Updated: 2023-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
2228 participants
INTERVENTIONAL
2021-11-09
2025-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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vFFR guided revascularization
vFFR guided revascularization
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 revascularization
FFR guided revascularization
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)
Interventions
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vFFR guided revascularization
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 revascularization
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)
Eligibility Criteria
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Inclusion Criteria
2. Presenting with silent ischemia, stable angina, or non-ST-elevation acute coronary syndrome (NSTE-ACS)
3. Coronary artery disease with at least one native artery in which the stenosis severity is questionable (typically 30-80% stenosis)
4. FFR assessment and vFFR assessment feasible
5. The patient is willing and able to cooperate with study procedures and follow-up until study completion
6. 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
Exclusion Criteria
2. 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
3. Any target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow \<3.
4. Presence of thrombus in intermediate target lesion.
5. Known untreated severe valvular heart disease
6. Target lesion is located in or supplied by an arterial or venous bypass graft
7. History of cardiac allograft transplantation
8. Aorto-ostial lesions with an estimated diameter stenosis \>50%
9. Severe tortuosity precluding the acquisitions of 2 orthogonal projections of the target vessel with minimal overlap or foreshortening.
10. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or adenosine
11. Non-cardiac co-morbidities with a life expectancy less than 1 year
12. 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
13. Women of childbearing potential who do not have a negative pregnancy test within 24 hours before the procedure
14. Subject belongs to a vulnerable population (per Investigator's judgment) or subject unable to read or write
18 Years
ALL
No
Sponsors
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Siemens Healthineers AG
UNKNOWN
Pie Medical Imaging
UNKNOWN
ECRI bv
INDUSTRY
Responsible Party
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Principal Investigators
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Joost Daemen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Ernest Spitzer, MD
Role: STUDY_DIRECTOR
European Cardiovascular Research Institute
Locations
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Clinique St Martin
Caen, , France
Institut Cardiovasculaire de Grenoble
Grenoble, , France
CHU LILLE - Institut Cœur Poumon
Lille, , France
Hôpital de la Croix Rousse, hospices civils de lyon
Lyon, , France
Hôpital Privé Jacques Cartier
Massy, , France
Clinique les Fontaines
Melun, , France
Clinique Saint Hilaire
Rouen, , France
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
Charité- Campus Benjamin Franklin
Berlin, , Germany
Unfallkrankenhaus Berlin
Berlin, , Germany
Universitatsklinikum Dusseldorf
Düsseldorf, , Germany
Marienhaus Klinikum
Neuwied, , Germany
SHG Klinik Völklingen
Völklingen, , Germany
Mater Private Cork
Cork, , Ireland
Beaumont Hospital
Dublin, , Ireland
Mater Private Dublin
Dublin, , Ireland
St James Hospital
Dublin, , Ireland
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
AOU di Ferrara (Ospedale Sant'Anna)
Cona, , Italy
Cardiologia Ospedale Dell' Angelo
Mestre, , Italy
Humanitas Research Hospital
Milan, , Italy
Policlinico San Donato
Milan, , Italy
Pineta Grande Hospital
Naples, , Italy
Ospedale Maggiore della Carità
Novara, , Italy
AOU Verona
Verona, , Italy
Cardiologia Ospedale San Bortolo
Vicenza, , Italy
Tergooi MC
Blaricum, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Albert Schweitzer
Dordrecht, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
UMCU
Utrecht, , Netherlands
Hospital Univeritario A Coruna
A Coruña, , Spain
Hospital Clinic
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitario de Leon
León, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
La Paz
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Royal Victoria Hospital
Belfast, , United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
Golden Jubilee National Hospital
Glasgow, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Scoccia 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.
Other Identifiers
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ECRI-15
Identifier Type: -
Identifier Source: org_study_id
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