Clinical trial NCT04931771: Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization
Official title: Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Intermediate coronary lesion
Coronary physiology
vFFR
Lead sponsor: ECRI bv
Sponsor class: INDUSTRY
Collaborators: name: Siemens Healthineers AG
name: Pie Medical Imaging
First posted: 2021-06-18
Enrollment: 2228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. The patient must be ≥18 years of age
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:

1. ST-elevation myocardial infarction (STEMI) at presentation
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

Primary outcomes:
measure: Rate of the composite of all-cause death, any myocardial infarction, or any revascularization
timeFrame: 1 year
Secondary outcomes:
measure: Rate of patient-oriented composite endpoint (POCE) defined as all-cause death, any stroke, any myocardial infarction, and any revascularization
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: Rate of target-vessel failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization
timeFrame: 1 year
measure: Rate of target-lesion failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-lesion revascularization
timeFrame: 1 year
measure: Rate of study-vessel failure defined as a composite of cardiac death, study vessel myocardial infarction, or clinically indicated study-vessel revascularization
timeFrame: 1 year
measure: Rate of definite and probable stent thrombosis
timeFrame: 1 year
Other outcomes:
measure: Quality of life (QoL) using the Seattle Angina Questionnaire
timeFrame: 1 month and 1 year
measure: Procedural time
timeFrame: Baseline
measure: Total contrast volume
timeFrame: Baseline
measure: Fluoroscopy time
timeFrame: Baseline
measure: Radiation dose
timeFrame: Baseline
Locations:
city: Caen
country: France
facility: Clinique St Martin
city: Grenoble
country: France
facility: Institut Cardiovasculaire de Grenoble
city: Lille
country: France
facility: CHU LILLE - Institut Cœur Poumon
city: Lyon
country: France
facility: Hôpital de la Croix Rousse, hospices civils de lyon
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Melun
country: France
facility: Clinique les Fontaines
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Charité- Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Düsseldorf
country: Germany
facility: Universitatsklinikum Dusseldorf
city: Neuwied
country: Germany
facility: Marienhaus Klinikum
city: Völklingen
country: Germany
facility: SHG Klinik Völklingen
city: Cork
country: Ireland
facility: Mater Private Cork
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: Mater Private Dublin
city: Dublin
country: Ireland
facility: St James Hospital
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Cona
country: Italy
facility: AOU di Ferrara (Ospedale Sant'Anna)
city: Mestre
country: Italy
facility: Cardiologia Ospedale Dell' Angelo
city: Milan
country: Italy
facility: Humanitas Research Hospital
city: Milan
country: Italy
facility: Policlinico San Donato
city: Naples
country: Italy
facility: Pineta Grande Hospital
city: Novara
country: Italy
facility: Ospedale Maggiore della Carità
city: Verona
country: Italy
facility: AOU Verona
city: Vicenza
country: Italy
facility: Cardiologia Ospedale San Bortolo
city: Blaricum
country: Netherlands
facility: Tergooi MC
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Utrecht
country: Netherlands
facility: UMCU
city: A Coruña
country: Spain
facility: Hospital Univeritario A Coruna
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital del Mar
city: León
country: Spain
facility: Hospital Universitario de Leon
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: La Paz
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Erasmus Medical Center
name: Joost Daemen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: European Cardiovascular Research Institute
name: Ernest Spitzer, MD
role: STUDY_DIRECTOR
References: