FAVOR III (Functional Assessment by Virtual Online Reconstruction). Comparison of quantitative flow ratio (QFR) and conventional pressure-wire based functional evaluation for guiding coronary intervention. A randomized clinical non-inferiority trial

FAVOR III (Functional Assessment by Virtual Online Reconstruction). Comparison of quantitative flow ratio (QFR) and conventional pressure-wire based functional evaluation for guiding coronary intervention. A randomized clinical non-inferiority trial - FAVOR III

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54747

Enrollment

130

Registered

2019-06-11

Start date

2020-05-04

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

angina coronary stenosis

Interventions

randomization (1:1) to QFR based evaluation of FFR based evaluation of intermediate coronary stenosis.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Indication for invasive coronary angiography • Diameter stenosis of 40-90% and a vessel diameter of at least 2.5 mm and supplying viable myocardium • Patients with stable angina pectoris, or assessment of secondary lesions in stabilized non-STEMI patients or assessment of secondary lesions in patients with prior STEMI and staged evaluation of secondary lesions. • Patients with restenosis in a native coronary artery

Exclusion criteria

Exclusion criteria: • Severely impaired renal function: GFR 50% diameter stenosis • Left main coronary artery > 50% diameter stenosis

Design outcomes

Primary

Measure	Time frame
Major Adverse Cardiac Events (MACE): All-cause mortality, any myocardial infarction, and any unplanned revascularization at 12 months.	—

Secondary

Measure	Time frame
A composite of cardiac death, target vessel myocardial infarction and ischemic driven target vessel revascularization. Individual clinical endpoints• Major adverse cardiac events (MACE): all cause mortality, any myocardial infarction, and any unplanned revascularization at 24 months. * All-cause mortality at 30 days, one year and two years * Stroke at 30 days, one year en two years • Cardiac death at 30 days, one year and two years • Any myocardial infarction at 30 days, one year and two years • Target vessel myocardial infarction at 30 days, one year and two years • Any revascularization at 30 days, one year and two years • Ischemia driven target vessel revascularization at 30 days, one year and two years • Ischemia driven treated target lesion revascularization at 30 days, one year and two years • Ischemia driven measured segment target vessel revascularization at 30 days, one year and two years • Ischemia driven de novo revascularization at 30 days, one year and two years • Ischemia driven measured segment de novo revascularization at 30 days, one year and two years Procedural endpoints: • Feasibility of QFR • Feasibility of FFR • Number of lesion interrogated • Procedure time • Contrast volume • Fluoroscopy time • Number of stents implanted	—

Measure

Time frame

A composite of cardiac death, target vessel myocardial infarction and ischemic driven target vessel revascularization. Individual clinical endpoints• Major adverse cardiac events (MACE): all cause mortality, any myocardial infarction, and any unplanned revascularization at 24 months. * All-cause mortality at 30 days, one year and two years * Stroke at 30 days, one year en two years • Cardiac death at 30 days, one year and two years • Any myocardial infarction at 30 days, one year and two years • Target vessel myocardial infarction at 30 days, one year and two years • Any revascularization at 30 days, one year and two years • Ischemia driven target vessel revascularization at 30 days, one year and two years • Ischemia driven treated target lesion revascularization at 30 days, one year and two years • Ischemia driven measured segment target vessel revascularization at 30 days, one year and two years • Ischemia driven de novo revascularization at 30 days, one year and two years • Ischemia driven measured segment de novo revascularization at 30 days, one year and two years Procedural endpoints: • Feasibility of QFR • Feasibility of FFR • Number of lesion interrogated • Procedure time • Contrast volume • Fluoroscopy time • Number of stents implanted

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)