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

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

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).

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.

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