NCT04356027: FUSION

FUnctional diagnoSIs of corONary Stenosis (FUSION)

Completed Results posted Last updated 21 February 2025

What this trial tests

trial testing ICA (Invasive Coronary Angiography) in Coronary Artery Disease in 312 participants. Completed in 15 October 2021.

Timeline

26 June 2020

Primary endpoint
15 October 2021

15 October 2021

Quick facts

Lead sponsor	Abbott Medical Devices
Status	Completed
Study type	OBSERVATIONAL
Enrollment	312
Start date	26 June 2020
Primary completion	15 October 2021
Estimated completion	15 October 2021
Sites	28 locations across United States

Drugs / interventions tested

• ICA (Invasive Coronary Angiography)
• OCT
• FFR
• VFR Analysis

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Coronary Stenosis — all drugs for Coronary Stenosis →

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Coronary Artery Disease or Coronary Stenosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR) Primary · Baseline (pre-procedure) and immediately post-procedure

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

Sensitivity

Group	Value	95% CI
Standard of Care: Angiography, OCT, FFR, and VFR	82

Specificity

Group	Value	95% CI
Standard of Care: Angiography, OCT, FFR, and VFR	136

Overall Diagnostic Accuracy Secondary · 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.

Group	Value	95% CI
Standard of Care: Angiography, OCT, FFR, and VFR	218

Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Secondary · 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.

PPV number analyzed

Group	Value	95% CI
Standard of Care: Angiography, OCT, FFR, and VFR	82

NPV number analyzed

Group	Value	95% CI
Standard of Care: Angiography, OCT, FFR, and VFR	136

Correlation Between VFR and FFR Secondary · 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.

Group	Value	95% CI
Standard of Care: Angiography, OCT, FFR, and VFR	0.4992	0.4105 – 0.5807

Area Under Curve (AUC) Against FFR Secondary · 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.

Group	Value	95% CI
Standard of Care: Angiography, OCT, FFR, and VFR	0.8790	0.8380 – 0.9199

Adverse events — posted to ClinicalTrials.gov

Time frame: Immediately post-procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

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

Serious: 5/312 (2%)

Deaths: 0/312

Serious adverse events (3 terms)

Reaction	System	Standard of Care: Angiogra…
Vascular Dissection	Vascular disorders	—
Hypotension	Vascular disorders	—
Vessel Perforation	Vascular disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	Standard of Care: Angiogra…
Angina Pectoris	Cardiac disorders	—
Atrial Fibrillation	Cardiac disorders	—
Pericardial Effusion	Cardiac disorders	—
Vascular Dissection	Vascular disorders	—

Most-reported serious reactions: Vascular Dissection, Hypotension, Vessel Perforation.

Data from ClinicalTrials.gov NCT04356027 adverse events section.

Sponsor's own description

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).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intracoronary optical coherence tomography: state of the art and future directions.
   Ali ZA, Karimi Galougahi K, Mintz GS, Maehara A, et al · · 2021 · cited 87× · PMID 34110288 · DOI 10.4244/eij-d-21-00089
2. Optical Coherence Tomography-Based Functional Stenosis Assessment: FUSION-A Prospective Multicenter Trial.
   Jeremias A, Maehara A, Matsumura M, Shlofmitz RA, et al · · 2024 · cited 12× · PMID 38525609 · DOI 10.1161/circinterventions.123.013702
3. Unlocking the Secrets of Acute Coronary Syndromes Using Intravascular Imaging: From Pathophysiology to Improving Outcomes.
   Apostolos A, Karanasos A, Ktenopoulos N, Tsalamandris S, et al · · 2024 · cited 6× · PMID 39685545 · DOI 10.3390/jcm13237087
4. Combining Optical Coherence Tomography and Fractional Flow Reserve for Decision Making in Percutaneous Coronary Intervention: Insights From the FUSION Study.
   Volleberg RHJA, Shin D, Shlofmitz RA, Maksoud A, et al · · 2025 · PMID 41324056 · DOI 10.1016/j.jscai.2025.104001
5. The Continuum of Invasive Techniques for the Assessment of Intermediate Coronary Lesions.
   Popa-Fotea NM, Scafa-Udriste A, Dorobantu M. · · 2022 · PMID 35741302 · DOI 10.3390/diagnostics12061492