The purpose of the FUSION study is to validate the diagnostic performance of Virtual Flow Reserve (VFR) by comparing it against a reference standard, fractional flow reserve (FFR).
This study is a single-arm, prospective, multi-center study collecting OCT pullback images of lesions pre-percutaneous coronary intervention (PCI) and (optional) post-PCI procedure, and the corresponding pressure tracings and physiology indices. Up to 30 centers in the US will enroll approximately 310 patients. The expected duration of enrollment is approximately 15 months. The total duration of the clinical investigation is expected to be approximately 27 months.
Study Type
OBSERVATIONAL
Enrollment
312
Patients will undergo a Pre-PCI Angiography
OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure
FFR will be measured
Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR)
Sensitivity and specificity of the VFR compared with FFR each of which will be tested against a prespecified performance goal. FFR with a binary cut-off of 0.80 will be used as the reference standard for comparison. FFR or VFR value ≤ 0.80 will be considered positive (ischemia-causing), and FFR or VFR value \> 0.80 will be considered negative (non-ischemia-causing). Sensitivity is defined as the percentage of VFR positive lesions, in the group of FFR positive lesions. Sensitivity=TP/(TP+FN) x 100%, where TP denotes the number of True Positives (both VFR and FFR positive) and FN denotes the number of False Negatives (VFR negative but FFR positive). Specificity is defined as the percentage of VFR negative lesions in the group of FFR negative lesions. Specificity=TN/(TN+FP) x 100%, where TN denotes the number of True Negatives (both VFR and FFR negatives) and FP denotes the number of False Positives (VFR positive but FFR negative).
Time frame: Baseline (pre-procedure) and immediately post-procedure
Overall Diagnostic Accuracy
Overall diagnostic accuracy is defined as the proportion of correctly classified lesions among all lesions. Overall Diagnostic Accuracy= (TP+TN)/(TP+TN+FP+FN) x 100%, where TP denotes the number of True Positives, FN denotes the number of False Negatives, TN denotes the number of True Negatives, and FN denotes the number of False Negatives.
Time frame: Baseline (pre-procedure) and immediately post-procedure
Positive Predictive Value (PPV) and Negative Predictive Value (NPV)
PPV is defined as the proportion of lesions with the disease and with a positive test result among the group of lesions with a positive test result. PPV= TP/(TP+FP) x 100%, where TP denotes the number of True Positives and FP denotes the number of False Positives. NPV is defined as the proportion of lesions without the disease and with a negative test result among the group of lesions with negative test results. NPV= TN/(TN+FN) x 100%, where TN denotes the number of True Negatives and FN denotes the number of False Negatives.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
VFR will be calculated offline using the OCT pullback images
Heart Center Research, LLC.
Huntsville, Alabama, United States
HonorHealth
Scottsdale, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
VA Palo Alto Medical Center
Palo Alto, California, United States
UCLA Medical Center Santa Monica
Santa Monica, California, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
The Cardiac & Vascular Institute Research Foundation, LLC
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
...and 18 more locations
Time frame: Baseline (pre-procedure) and immediately post-procedure
Correlation Between VFR and FFR
The correlation between VFR and FFR will be estimated as the R\^2 correlation coefficient from the simple linear regression model using VFR value as the independent variable and FFR as the dependent variable.
Time frame: Baseline (pre-procedure) and immediately post-procedure (post-procedure)
Area Under Curve (AUC) Against FFR
AUC will be estimated as the area under the ROC curve. ROC curve will be constructed using specificity on the x-axis and sensitivity on the y-axis. Sensitivity and specificity are calculated at various values of VFR and FFR, and the AUC curve will be drawn using logistic regression.
Time frame: Baseline (pre-procedure) and immediately post-procedure (post-procedure)