Back to resultsFractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization (FAST III)
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
vFFR guided revascularization
FFR guided revascularization
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Intermediate coronary lesion, Coronary physiology, vFFR
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Clinique St MartinRecruiting
- Institut Cardiovasculaire de Grenoble
- CHU LILLE - Institut Cœur PoumonRecruiting
- Hôpital de la Croix Rousse, hospices civils de lyonRecruiting
- Hôpital Privé Jacques Cartier
- Clinique les FontainesRecruiting
- Clinique Saint HilaireRecruiting
- Herz- und Diabeteszentrum NRWRecruiting
- Charité- Campus Benjamin FranklinRecruiting
- Unfallkrankenhaus BerlinRecruiting
- Universitatsklinikum Dusseldorf
- Marienhaus KlinikumRecruiting
- SHG Klinik VölklingenRecruiting
- Mater Private CorkRecruiting
- Beaumont Hospital
- Mater Private DublinRecruiting
- St James HospitalRecruiting
- Azienda Ospedaliera Papa Giovanni XXIIIRecruiting
- AOU di Ferrara (Ospedale Sant'Anna)Recruiting
- Cardiologia Ospedale Dell' AngeloRecruiting
- Humanitas Research HospitalRecruiting
- Policlinico San DonatoRecruiting
- Pineta Grande Hospital
- Ospedale Maggiore della CaritàRecruiting
- AOU Verona
- Cardiologia Ospedale San BortoloRecruiting
- Tergooi MCRecruiting
- Amphia ZiekenhuisRecruiting
- Albert SchweitzerRecruiting
- Erasmus University Medical CenterRecruiting
- UMCURecruiting
- Hospital Univeritario A CorunaRecruiting
- Hospital ClinicRecruiting
- Hospital del MarRecruiting
- Hospital Universitario de Leon
- Hospital Universitario de la PrincesaRecruiting
- La PazRecruiting
- Hospital Universitario Central de AsturiasRecruiting
- Hospital Clinico Universitario de ValladolidRecruiting
- Royal Victoria Hospital
- Royal Sussex County HospitalRecruiting
- Golden Jubilee National HospitalRecruiting
- John Radcliffe HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
vFFR guided revascularization
FFR guided revascularization
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rate of patient-oriented composite endpoint (POCE) defined as all-cause death, any stroke, any myocardial infarction, and any revascularization
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
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
Rate of target-vessel failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization
Rate of target-lesion failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-lesion revascularization
Rate of study-vessel failure defined as a composite of cardiac death, study vessel myocardial infarction, or clinically indicated study-vessel revascularization
Rate of definite and probable stent thrombosis
Full Information
NCT ID
NCT04931771
First Posted
June 7, 2021
Last Updated
October 17, 2023
Sponsor
ECRI bv
Collaborators
Siemens Healthineers AG, Pie Medical Imaging
1. Study Identification
Unique Protocol Identification Number
NCT04931771
Brief Title
Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization
Acronym
FAST III
Official Title
Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ECRI bv
Collaborators
Siemens Healthineers AG, Pie Medical Imaging
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Intermediate coronary lesion, Coronary physiology, vFFR
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2228 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vFFR guided revascularization
Arm Type
Experimental
Arm Title
FFR guided revascularization
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
vFFR guided revascularization
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
FFR guided revascularization
Intervention Description
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)
Primary Outcome Measure Information:
Title
Rate of the composite of all-cause death, any myocardial infarction, or any revascularization
Description
Procedural myocardial infarction (MI) is adjudicated according to the ARC-2 consensus and spontaneous MI according to the 4th Universal definition of MI.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rate of patient-oriented composite endpoint (POCE) defined as all-cause death, any stroke, any myocardial infarction, and any revascularization
Time Frame
1 year
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Rate of definite and probable stent thrombosis
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Quality of life (QoL) using the Seattle Angina Questionnaire
Time Frame
1 month and 1 year
Title
Procedural time
Time Frame
Baseline
Title
Total contrast volume
Time Frame
Baseline
Title
Fluoroscopy time
Time Frame
Baseline
Title
Radiation dose
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ernest Spitzer, MD
Phone
+31102062828
Email
E.Spitzer@ECRI-Trials.com
First Name & Middle Initial & Last Name or Official Title & Degree
Monique Schuijer, PhD
Phone
+31102062828
Email
MSchuijer@cardialysis.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joost Daemen, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ernest Spitzer, MD
Organizational Affiliation
European Cardiovascular Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Clinique St Martin
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Fancois Morelle, MD, PhD
Facility Name
Institut Cardiovasculaire de Grenoble
City
Grenoble
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Faurie, MD, PhD
Facility Name
CHU LILLE - Institut Cœur Poumon
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric van Belle, MD, PhD
Facility Name
Hôpital de la Croix Rousse, hospices civils de lyon
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brahim Harbaoui, MD, PhD
Facility Name
Hôpital Privé Jacques Cartier
City
Massy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Hovasse, MD, PhD
Facility Name
Clinique les Fontaines
City
Melun
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Dupouy, MD, PhD
Facility Name
Clinique Saint Hilaire
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu Godin, MD, PhD
Facility Name
Herz- und Diabeteszentrum NRW
City
Bad Oeynhausen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regine Brinkmann, MD, PhD
Facility Name
Charité- Campus Benjamin Franklin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulf Landmesser, MD, PhD
Facility Name
Unfallkrankenhaus Berlin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steffen Bohl, MD, PhD
Facility Name
Universitatsklinikum Dusseldorf
City
Düsseldorf
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Wolff, MD, PhD
Facility Name
Marienhaus Klinikum
City
Neuwied
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burkhard Huegl, MD, PhD
Facility Name
SHG Klinik Völklingen
City
Völklingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Gatto, MD, PhD
Facility Name
Mater Private Cork
City
Cork
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronan Margey, MD, PhD
Facility Name
Beaumont Hospital
City
Dublin
Country
Ireland
Individual Site Status
Withdrawn
Facility Name
Mater Private Dublin
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Byrne, MD, PhD
Facility Name
St James Hospital
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Cosgrave, MD, PhD
Facility Name
Azienda Ospedaliera Papa Giovanni XXIII
City
Bergamo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Canova, MD, PhD
Facility Name
AOU di Ferrara (Ospedale Sant'Anna)
City
Cona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Biscaglia, MD, PhD
Facility Name
Cardiologia Ospedale Dell' Angelo
City
Mestre
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Barbierato, MD, PhD
Facility Name
Humanitas Research Hospital
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Mangieri, MD, PhD
Facility Name
Policlinico San Donato
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Testa, Md, PhD
Facility Name
Pineta Grande Hospital
City
Naples
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arturo Giordano, MD, PhD
Facility Name
Ospedale Maggiore della Carità
City
Novara
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domenico D'Amario, MD, PhD
Facility Name
AOU Verona
City
Verona
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Cardiologia Ospedale San Bortolo
City
Vicenza
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavio Ribichini, MD, PhD
Facility Name
Tergooi MC
City
Blaricum
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rutger van Bommel, MD, PhD
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martijn Meuwissen., MD, PhD
Facility Name
Albert Schweitzer
City
Dordrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohit Oemrawsing, MD, PhD
Facility Name
Erasmus University Medical Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joost Daemen, MD, PhD
Email
j.daemen@erasmusmc.nl
Facility Name
UMCU
City
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michiel Voskuil, MD, PhD
Facility Name
Hospital Univeritario A Coruna
City
A Coruña
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Piñón Esteban, MD, PhD
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manel Sabate, MD, PhD
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriz Vaquerizo, MD, PhD
Facility Name
Hospital Universitario de Leon
City
León
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Thiscal López Lluva, MD, PhD
Facility Name
Hospital Universitario de la Princesa
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Rivero, MD, PhD
Facility Name
La Paz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raul Moreno, MD, PhD
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Avanzas, MD, PhD
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Amat Santos, MD, PhD
Facility Name
Royal Victoria Hospital
City
Belfast
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Royal Sussex County Hospital
City
Brighton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Cockburn, MD, PhD
Facility Name
Golden Jubilee National Hospital
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien Collison, MD, PhD
Facility Name
John Radcliffe Hospital
City
Oxford
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian Banning, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization
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