CompletedNot Applicable

Diagnostic Accuracy of On-line Quantitative Flow Ratio (QFR). FAVOR II Europe-Japan

Denmark, France, Germany329 participantsStarted 2017-02-22

Plain-language summary

Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is assessed by calculation of the pressure in the vessel based on two angiographic projections. The purpose of the FAVOR II study is to evaluate the diagnostic accuracy of on-line QFR compared to 2D Quantitative Coronary Angiography (QCA) with FFR as gold standard.

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: * Stable angina pectoris or secondary evaluation of stenosis after acute MI * Age \> 18 years * Able to provide signed informed consent * Angiographic inclusion criteria: * Indication for FFR in at least one stenosis: * Diameter stenosis of 30%-90% by visual estimate * Reference vessel size \> 2 mm in stenotic segment by visual estimate Exclusion Criteria: * Myocardial infarction within 72 hours * Severe asthma or severe chronic obstructive pulmonary disease * Severe heart failure (NYHA≥III) * S-creatinine\>150µmol/L or GFR\<45 ml/kg/1.73m2 * Allergy to contrast media or adenosine * Atrial fibrillation * Angiographic exclusion criteria: Lesion specific * Below 30% and above 90% diameter stenosis by visual estimate. * Reference size of vessel below 2 mm by visual estimation. * Ostial LMCA lesions * Ostial RCA lesions * Distal LMCA lesions in combination with proximal Cx lesions * Other bifurcation stenosis with lesions on both sides of a major shift (\>1mm) in reference diameter Angiographic quality * Poor image quality precluding contour detection * Good contrast filling not possible * Severe overlap of stenosed segments * Severe tortuosity of target vessel

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

Sensitivity: Proportion of Patients With Positive QFR of FFR Positive Patients (True Positives) Compared to Proportion of Patients With Positive Percentual Diameter Stenosis (DS%) Assessed by 2D QCA of FFR Positive Patients (True Positives)

Timeframe: 1 hour

Specificity: Proportion of Patients With Negative QFR of FFR Negative Patients (True Negatives) Compared to Proportion of Patients With Negative DS% Assessed by 2D QCA of FFR Negative Patients (True Negatives)

Timeframe: 1 hour

Trial details

NCT IDNCT02959814

SponsorAarhus University Hospital Skejby

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-10-17

Results submitted2019-07-01

View on ClinicalTrials.gov More Coronary Artery Disease trials

Plain-language summary

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.

What they're measuring

Timeframe: 1 hour