Trial Outcomes & Findings for FUnctional diagnoSIs of corONary Stenosis (FUSION) (NCT NCT04356027)

Last Updated: 2025-02-21

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

312 participants

Primary outcome timeframe

Baseline (pre-procedure) and immediately post-procedure

Results posted on

2025-02-21

Participant Flow

The study enrolled a total of 312 subjects with a total of 315 vessels from 27 sites. After being reviewed for quality by the core laboratory, 224 pre-PCI and 42 post-PCI vessels from 224 subjects remained for the endpoints analysis.

Unit of analysis: vessels

Participant milestones

Participant milestones
Measure	Standard of Care: Angiography, OCT, FFR, and VFR This is a single arm study. Patients will have Pre-OCT Angiography, OCT pullbacks, a FFR measurement and a VFR analysis ICA (Invasive Coronary Angiography): Patients will undergo a Pre-PCI Angiography OCT: OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure FFR: FFR will be measured VFR Analysis: VFR will be calculated offline using the OCT pullback images
Overall Study STARTED	224 266
Overall Study Pre PCI	224 224
Overall Study Post PCI	224 42
Overall Study COMPLETED	224 266
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FUnctional diagnoSIs of corONary Stenosis (FUSION)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care: Angiography, OCT, FFR, and VFR n=224 Participants This is a single arm study. Patients will have Pre-OCT Angiography, OCT pullbacks, a FFR measurement and a VFR analysis ICA (Invasive Coronary Angiography): Patients will undergo a Pre-PCI Angiography OCT: OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure FFR: FFR will be measured VFR Analysis: VFR will be calculated offline using the OCT pullback images
Age, Continuous	67.4 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants
Sex: Female, Male Male	156 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	191 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants
Region of Enrollment United States	224 participants n=5 Participants
Hyperlipidemia	186 participants n=5 Participants
Hypertension	182 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pre-procedure) and immediately post-procedure

Population: The primary analysis population included vessels in enrolled subjects having acceptable OCT pullbacks and pressure tracings for computing both the VFR and FFR indices. This is a single-arm study, so there is no data to report per arm, only data collected at different time points throughout the study.

Outcome measures

Outcome measures
Measure	Standard of Care: Angiography, OCT, FFR, and VFR n=266 Vessels This is a single arm study. Patients will have Pre-OCT Angiography, OCT pullbacks, a FFR measurement and a VFR analysis ICA (Invasive Coronary Angiography): Patients will undergo a Pre-PCI Angiography OCT: OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure FFR: FFR will be measured VFR Analysis: VFR will be calculated offline using the OCT pullback images
Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR) Sensitivity	82 vessels
Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR) Specificity	136 vessels

SECONDARY outcome

Timeframe: Baseline (pre-procedure) and immediately post-procedure

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.

Outcome measures

Outcome measures
Measure	Standard of Care: Angiography, OCT, FFR, and VFR n=266 Vessels This is a single arm study. Patients will have Pre-OCT Angiography, OCT pullbacks, a FFR measurement and a VFR analysis ICA (Invasive Coronary Angiography): Patients will undergo a Pre-PCI Angiography OCT: OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure FFR: FFR will be measured VFR Analysis: VFR will be calculated offline using the OCT pullback images
Overall Diagnostic Accuracy	218 vessels

SECONDARY outcome

Timeframe: Baseline (pre-procedure) and immediately post-procedure

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.

Outcome measures

Outcome measures
Measure	Standard of Care: Angiography, OCT, FFR, and VFR n=266 Vessels This is a single arm study. Patients will have Pre-OCT Angiography, OCT pullbacks, a FFR measurement and a VFR analysis ICA (Invasive Coronary Angiography): Patients will undergo a Pre-PCI Angiography OCT: OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure FFR: FFR will be measured VFR Analysis: VFR will be calculated offline using the OCT pullback images
Positive Predictive Value (PPV) and Negative Predictive Value (NPV) PPV number analyzed	82 vessels
Positive Predictive Value (PPV) and Negative Predictive Value (NPV) NPV number analyzed	136 vessels

SECONDARY outcome

Timeframe: Baseline (pre-procedure) and immediately post-procedure (post-procedure)

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.

Outcome measures

Outcome measures
Measure	Standard of Care: Angiography, OCT, FFR, and VFR n=266 Vessels This is a single arm study. Patients will have Pre-OCT Angiography, OCT pullbacks, a FFR measurement and a VFR analysis ICA (Invasive Coronary Angiography): Patients will undergo a Pre-PCI Angiography OCT: OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure FFR: FFR will be measured VFR Analysis: VFR will be calculated offline using the OCT pullback images
Correlation Between VFR and FFR	0.4992 correlation coefficient Interval 0.4105 to 0.5807

SECONDARY outcome

Timeframe: Baseline (pre-procedure) and immediately post-procedure (post-procedure)

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.

Outcome measures

Outcome measures
Measure	Standard of Care: Angiography, OCT, FFR, and VFR n=266 Vessels This is a single arm study. Patients will have Pre-OCT Angiography, OCT pullbacks, a FFR measurement and a VFR analysis ICA (Invasive Coronary Angiography): Patients will undergo a Pre-PCI Angiography OCT: OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure FFR: FFR will be measured VFR Analysis: VFR will be calculated offline using the OCT pullback images
Area Under Curve (AUC) Against FFR	0.8790 probability Interval 0.838 to 0.9199

Adverse Events

Standard of Care: Angiography, OCT, FFR, and VFR

Serious events: 5 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard of Care: Angiography, OCT, FFR, and VFR n=312 participants at risk This is a single arm study. Patients will have Pre-OCT Angiography, OCT pullbacks, a FFR measurement and a VFR analysis ICA (Invasive Coronary Angiography): Patients will undergo a Pre-PCI Angiography OCT: OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure FFR: FFR will be measured VFR Analysis: VFR will be calculated offline using the OCT pullback images
Vascular disorders Vascular Dissection	0.64% 2/312 • Immediately post-procedure The study enrolled a total of 312 subjects with a total of 315 vessels from 27 sites. After being reviewed for quality by the core laboratory, only 224 pre-PCI and 42 post-PCI vessels from 224 subjects remained for the endpoints analysis
Vascular disorders Hypotension	0.64% 2/312 • Immediately post-procedure The study enrolled a total of 312 subjects with a total of 315 vessels from 27 sites. After being reviewed for quality by the core laboratory, only 224 pre-PCI and 42 post-PCI vessels from 224 subjects remained for the endpoints analysis
Vascular disorders Vessel Perforation	0.32% 1/312 • Immediately post-procedure The study enrolled a total of 312 subjects with a total of 315 vessels from 27 sites. After being reviewed for quality by the core laboratory, only 224 pre-PCI and 42 post-PCI vessels from 224 subjects remained for the endpoints analysis

Other adverse events

Other adverse events
Measure	Standard of Care: Angiography, OCT, FFR, and VFR n=312 participants at risk This is a single arm study. Patients will have Pre-OCT Angiography, OCT pullbacks, a FFR measurement and a VFR analysis ICA (Invasive Coronary Angiography): Patients will undergo a Pre-PCI Angiography OCT: OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure FFR: FFR will be measured VFR Analysis: VFR will be calculated offline using the OCT pullback images
Cardiac disorders Angina Pectoris	0.32% 1/312 • Immediately post-procedure The study enrolled a total of 312 subjects with a total of 315 vessels from 27 sites. After being reviewed for quality by the core laboratory, only 224 pre-PCI and 42 post-PCI vessels from 224 subjects remained for the endpoints analysis
Cardiac disorders Atrial Fibrillation	0.32% 1/312 • Immediately post-procedure The study enrolled a total of 312 subjects with a total of 315 vessels from 27 sites. After being reviewed for quality by the core laboratory, only 224 pre-PCI and 42 post-PCI vessels from 224 subjects remained for the endpoints analysis
Cardiac disorders Pericardial Effusion	0.32% 1/312 • Immediately post-procedure The study enrolled a total of 312 subjects with a total of 315 vessels from 27 sites. After being reviewed for quality by the core laboratory, only 224 pre-PCI and 42 post-PCI vessels from 224 subjects remained for the endpoints analysis
Vascular disorders Vascular Dissection	0.32% 1/312 • Immediately post-procedure The study enrolled a total of 312 subjects with a total of 315 vessels from 27 sites. After being reviewed for quality by the core laboratory, only 224 pre-PCI and 42 post-PCI vessels from 224 subjects remained for the endpoints analysis

Additional Information

Tarn Teraphongphom, Principal Clinical Research Scientist

Abbott

Phone: +1 (408) 931-0504

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60