Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The F… (NCT06039748) | Clinical Trial Compass
CompletedNot Applicable
Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study
China330 participantsStarted 2023-09-13
Plain-language summary
Coronary angiography-derived FFR assessment (AngioQFA) is a novel technique for physiological lesion assessment based on 3-dimensional (3D) quantitative coronary angiography (QCA) and virtual hyperemic flow derived from contrast frame count without drug-induced hyperemia. The goal of this prospective, multicenter trial is to compare the diagnostic performance of AngioQFA with invasive FFR as the reference standard. The secondary purpose is to compare the diagnostic accuracies of the computational fluid dynamics (CFD)-based index of microcirculatory resistance (IMR) using wire-based IMR 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
. Age ≥18 years.
. Coronary angiography is required for patients with suspected or confirmed coronary artery disease.
. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
. Diameter stenosis of 30%-90% by visual estimate
. Reference vessel size ≥2 mm in stenotic segment by visual estimate
Exclusion criteria
. Subject has undergone CABG of the 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
1
Diagnostic sensitivity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.
Timeframe: 1 hour
2
Diagnostic sensitivity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.
Timeframe: 1 hour
3
Diagnostic specificity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.
Timeframe: 1 hour
4
Diagnostic specificity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.
Timeframe: 1 hour
Trial details
NCT IDNCT06039748
SponsorShenzhen Raysight Intelligent Medical Technology Co., Ltd.
. Evidence of an acute myocardial infarction within one week prior to the intended procedure.
. Severe heart failure (NYHA≥III)
. Patients with other serious conditions not eligible for clinical trials, such as severe arrhythmia or tachycardia, sinus syndrome, asthma, severe chronic obstructive pulmonary disease.
. Serum creatinine level of \>150µmol / L.
. Subject has known allergy to iodinated contrast agents, adenosine, or ATP.