CompletedNot Applicable

The FAVOR II China Study

China308 participantsStarted 2017-06-13

Plain-language summary

Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. The purpose of the FAVOR II China study is to evaluate the diagnostic accuracy of on-line QFR with FFR as the reference standard. The secondary purpose is to compare the diagnostic accuracies between online QFR and online QCA, with FFR as the reference 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: General Criteria: * Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI * Age \> 18 years * Able to provide signed informed consent Angiographic inclusion criteria: * At least one stenosis with diameter stenosis of 30%-90% by visual estimate * Reference vessel size \> 2 mm in stenotic segment by visual estimate Exclusion Criteria: General Criteria: * Ineligible for diagnostic intervention or FFR examination * Myocardial infarction within 72 hours * Severe heart failure (NYHA≥III) * S-creatinine\>150µmol/L or GFR\<45 ml/kg/1.73m2 * Allergy to contrast agent or adenosine * Factors that might substantially impact the angiographic image quality, e.g, frequent atrial premature beat or atrial fibrillation Angiographic exclusion criteria: * The interrogated stenosis is caused by myocardial bridge * Ostial lesions less than 3 mm to the aorta * Side branches of the bifurcation lesions with Median Classification of 111 or 101 * Poor angiographic image quality precluding contour detection * Severe overlap of stenotic 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

Diagnostic accuracy of online QFR to determine presence or absence of hemodynamically-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard.

Timeframe: 1 hour

Trial details

NCT IDNCT03191708

SponsorChina National Center for Cardiovascular Diseases

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2017-07-20

View on ClinicalTrials.gov More Coronary Artery Disease trials