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 - FAST III

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54348

Enrollment

800

Registered

2021-10-18

Start date

2021-11-09

Completion date

Unknown

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermediate coronary artery stenosis

Interventions

(v)FFR guided revascularization

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 2. Presenting with silent ischemia, stable angina, non-ST-elevation acute coronary syndrome (NSTE-ACS), or stabilized STEMI (>72h post culprit treatment) 3. Coronary artery disease with at least one native artery in which the stenosis severity is questionable (typically 30-80% stenosis) 4. vFFR guided revascularization considered feasible (see vFFR training manual)

Exclusion criteria

Exclusion criteria: 1. Acute treatment of ST-elevation myocardial infarction (STEMI) 2. Cardiogenic shock or severe hemodynamic instability at the time of intervention (as defined by the interventionalist) or use of left ventricular assist device 3. A study lesion cannot be in a vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow 50% 9. Severe tortuosity precluding the acquisitions of 2 orthogonal projections of the target vessel with minimal overlap or foreshortening

Design outcomes

Primary

Measure	Time frame
Composite of all-cause death, any myocardial infarction, or any revascularization at 1 year.	—

Secondary

Measure	Time frame
1. Patient-oriented Composite Endpoint (POCE) defined as all-cause death, any stroke, any myocardial infarction, and any revascularization 2. Device-oriented Composite Endpoint (DOCE) defined as the composite of cardiovascular death, target-vessel MI, clinically indicated repeat revascularization of the target lesion 3. 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 4. Target-vessel failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization 5. Target-lesion Failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-lesion revascularization 6. Study-vessel failure defined as a composite of cardiac death, study vessel myocardial infarction, or clinically indicated study-vessel revascularization 7. Definite and probable stent thrombosis	—

Measure

Time frame

1. Patient-oriented Composite Endpoint (POCE) defined as all-cause death, any stroke, any myocardial infarction, and any revascularization 2. Device-oriented Composite Endpoint (DOCE) defined as the composite of cardiovascular death, target-vessel MI, clinically indicated repeat revascularization of the target lesion 3. 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 4. Target-vessel failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization 5. Target-lesion Failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-lesion revascularization 6. Study-vessel failure defined as a composite of cardiac death, study vessel myocardial infarction, or clinically indicated study-vessel revascularization 7. Definite and probable stent thrombosis

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026