Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization

Coronary Artery Disease Clinical Trial

— FAST III  

Official title:

Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04931771
• Other study ID #: ECRI-15
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2021
• Est. completion date: May 2025

Study information

• Verified date: October 2023
• Source: ECRI bv
• Contact: Ernest Spitzer, MD
• Phone: +31102062828
• Email: E.Spitzer[@]ECRI-Trials.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2228
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• 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)

Locations

Country	Name	City	State
France	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
Germany	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
Ireland	Mater Private Cork	Cork
Ireland	Beaumont Hospital	Dublin
Ireland	Mater Private Dublin	Dublin
Ireland	St James Hospital	Dublin
Italy	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
Netherlands	Tergooi MC	Blaricum
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Albert Schweitzer	Dordrecht
Netherlands	Erasmus University Medical Center	Rotterdam
Netherlands	UMCU	Utrecht
Spain	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
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (3)

Lead Sponsor	Collaborator
ECRI bv	Pie Medical Imaging, Siemens Healthineers AG

Countries where clinical trial is conducted

France,  Germany,  Ireland,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life (QoL) using the Seattle Angina Questionnaire		1 month and 1 year
Other	Procedural time		Baseline
Other	Total contrast volume		Baseline
Other	Fluoroscopy time		Baseline
Other	Radiation dose		Baseline
Primary	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.	1 year
Secondary	Rate of patient-oriented composite endpoint (POCE) defined as all-cause death, any stroke, any myocardial infarction, and any revascularization		1 year
Secondary	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		1 year
Secondary	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		1 year
Secondary	Rate of target-vessel failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization		1 year
Secondary	Rate of target-lesion failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-lesion revascularization		1 year
Secondary	Rate of study-vessel failure defined as a composite of cardiac death, study vessel myocardial infarction, or clinically indicated study-vessel revascularization		1 year
Secondary	Rate of definite and probable stent thrombosis		1 year