N/A N=329

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

Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT02959814 ↗

Enrolled (actual)

329

Serious AEs

0.0%

Results posted

Jan 2020

Primary outcome: Primary: 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) — 0.442; 0.865 Proportion

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: QFR (observational) (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aarhus University Hospital Skejby
Primary completion: Oct 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY 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)	0.442; 0.865	—
PRIMARY 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)	0.765; 0.869	—
SECONDARY Percentage of Patients With Successful QFR in Patients With Successful FFR (Feasibility)	296	—
SECONDARY Proportion of Patients With Positive QFR of FFR Positive Patients (True Positives) (Sensitivity)	0.865	—
SECONDARY Proportion of Patients With Negative QFR of FFR Negative Patients (True Negatives) (Specificity)	0.869	—
SECONDARY Proportion of Patients With Positive FFR (True Positives) of Patients With Positive QFR (Positive Predictive Value)	0.763	—
SECONDARY Proportion of Patients With Negative FFR (True Negatives) of Patients With Negative QFR (Negative Predictive Value)	0.930	—
SECONDARY Diagnostic Performance of QFR in Comparison to FFR Reported as Positive and Negative Likelihood Ratio	0.16; 6.60	—
SECONDARY Diagnostic Grey Zone Calculation. QFR Limits for Achieving 95% Sensitivity and Specificity in Comparison to FFR	0.77; 0.87	—
SECONDARY Diagnostic Accuracy of TIMI-flow Based QFR in Comparison to 2D QCA (>50% Diameter Stenosis)	0.868; 0.659	—
SECONDARY Participants With Myocardial Infarction (Number of Patients)	—	—
SECONDARY All-cause Mortality (Number of Patients)	—	—
SECONDARY Time to FFR	7.0	—
SECONDARY Time to QFR After Receiving Angiographic Images	5.0	—
SECONDARY Contrast Use	120	—
SECONDARY Fluoroscopy Time	9.8	—

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.

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02959814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.