UnknownNot Applicable

Functional Assessment by Virtual Online Reconstruction. The FAVOR III Europe Trial

Denmark, France, Germany2,001 participantsStarted 2018-11-06

Plain-language summary

Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is estimated based on two angiographic projections. Studies have shown a good correlation with the present wire-based standard approach Fractional Flow Reserve (FFR) for assessment of intermediate coronary stenosis. The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy will results in non-inferior clinical outcome after 12 months compared to a standard pressure-wire guided strategy in evaluation of patients with chest pain (stable angina pectoris) and intermediate coronary stenosis.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 treatme…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient oriented composite endpoint (PoCE)

Timeframe: 12 months

Trial details

NCT IDNCT03729739

SponsorAarhus University Hospital Skejby

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-21

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