Functional Assessment by Virtual Online Reconstruction. The FAVOR III Europe Japan Study

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT03729739
• Date of registration: 01/11/2018
• Prospective Registration: Yes
• Primary sponsor: Aarhus University Hospital Skejby
• Public title: Functional Assessment by Virtual Online Reconstruction. The FAVOR III Europe Japan Study FAVOR III EJ
• Scientific title: Comparison of Quantitative Flow Ratio (QFR) and Conventional Pressure-wire Based Functional Evaluation for Guiding Coronary Intervention. A Randomized Clinical Non-inferiority Trial
• Date of first enrolment: November 6, 2018
• Target sample size: 2001
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03729739
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Denmark, France, Germany, Italy, Japan, Latvia, Lithuania, Netherlands, Poland, Spain, Sweden, Switzerland

Contacts

• Name: Evald H. Christiansen, Prof.
• Affiliation: Aarhus University Hospital, Denmark

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age of 18 years and above

- Both genders

- Indication for invasive coronary angiography

- 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.

- Able to provide written informed consent

Angiographic inclusion criteria

- Diameter stenosis of 40-90% diameter stenosis

- Vessel diameter of at least 2.5 mm and supplying viable myocardium

- Patients with restenosis in a native coronary artery can be included

Exclusion Criteria:

- Severely impaired renal function: Glomerular filtration rate (GFR) < 20 mL/min/1.73m²

- Life expectancy less than one year

- Cardiogenic shock or unstable haemodynamic state (Killip class III and IV)

- ST-elevation myocardial infarction (STEMI) within 24 hours

- Bypass graft to any target vessel

- Atrial fibrillation at the time of the procedure

- Chronic total occlusions of any vessel with possible or established indication for
treatment

- Pregnancy or intention to become pregnant during the course of the trial

- Breast feeding

- Planned need for concomitant valvular or aortic surgery

- Left ventricular ejection fraction (LVEF) < 30%

- Previous inclusion in the FAVOR III trial

- Enrolled in another clinical study, and for this reason not treated according to
present European Society of Cardiology guidelines, or the protocol treatment conflicts
with the protocol treatment of FAVOR III

- Inability to tolerate contrast media

- Inability to tolerate Adenosine

Angiographic exclusion criteria

- Ostial right coronary artery > 50% diameter stenosis

- Left main coronary artery > 50% diameter stenosis

- Lesions properties indicative of myocardial bridging

- Bifurcation lesions with major (>1 mm) step down in reference size across the
bifurcation

- Severe tortuosity of any target vessel

- Severe overlap in the stenosed segment

- Poor image quality precluding identification of vessel contours



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Intervention(s)

Diagnostic Test: QFR-based diagnostic strategy

Diagnostic Test: FFR-based diagnostic strategy

Primary Outcome(s)

Patient oriented composite endpoint (PoCE) [Time Frame: 12 months]

Secondary Outcome(s)

Cardiac death [Time Frame: 24 months]

Contrast volume [Time Frame: 1 hour]

Ischemia driven, measured segment revascularization [Time Frame: 1 month]

Any ischemia driven de novo revascularization [Time Frame: 12 months]

Any unplanned revascularization [Time Frame: 12 months]

Ischemia driven measured segment de novo revascularization [Time Frame: 12 months]

Ischemia driven target vessel revascularization [Time Frame: 1 month]

All-cause mortality [Time Frame: 24 months]

Feasibility of QFR [Time Frame: 1 hour]

Ischemia driven, measured segment revascularization [Time Frame: 12 months]

Ischemia driven, measured segment revascularization [Time Frame: 24 months]

Any unplanned revascularization [Time Frame: 1 month]

Feasibility of FFR [Time Frame: 1 hour]

Myocardial infarction [Time Frame: 24 months]

Target vessel failure [Time Frame: 24 months]

Fluoroscopy time [Time Frame: 1 hour]

Ischemia driven measured segment de novo revascularization [Time Frame: 1 month]

Target vessel myocardial infarction [Time Frame: 1 month]

Cardiac death [Time Frame: 1 month]

Ischemia driven target vessel revascularization [Time Frame: 24 months]

Ischemia driven measured segment de novo revascularization [Time Frame: 24 months]

Ischemia driven target vessel revascularization [Time Frame: 12 months]

Number of stents implanted [Time Frame: 1 hour]

Procedure time [Time Frame: 1 hour]

Ischemia driven treated target lesion revascularization [Time Frame: 24 months]

Ischemia driven treated target lesion revascularization [Time Frame: 1 month]

Target vessel myocardial infarction [Time Frame: 12 months]

Any ischemia driven de novo revascularization [Time Frame: 24 months]

Any unplanned revascularization [Time Frame: 24 months]

Cardiac death [Time Frame: 12 months]

Myocardial infarction [Time Frame: 1 month]

All-cause mortality [Time Frame: 1 month]

All-cause mortality [Time Frame: 12 months]

Any ischemia driven de novo revascularization [Time Frame: 1 month]

Ischemia driven treated target lesion revascularization [Time Frame: 12 months]

Myocardial infarction [Time Frame: 12 months]

Number of lesion interrogated [Time Frame: 1 hour]

Target vessel failure [Time Frame: 1 month]

Target vessel failure [Time Frame: 12 months]

Target vessel myocardial infarction [Time Frame: 24 months]

Secondary ID(s)

1-10-72-263-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medis Medical Imaging Systems