N/A
N=224
FUnctional diagnoSIs of corONary Stenosis (FUSION)
Coronary Artery Disease · Coronary Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT04356027 ↗Enrolled (actual)
224
Serious AEs
1.6%
Results posted
Feb 2025
Primary outcome: Primary: Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR) — 82; 136 vessels
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ICA (Invasive Coronary Angiography) (Procedure); OCT (Procedure); FFR (Procedure); VFR Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR) |
82; 136 | — |
| SECONDARY Overall Diagnostic Accuracy |
218 | — |
| SECONDARY Positive Predictive Value (PPV) and Negative Predictive Value (NPV) |
82; 136 | — |
| SECONDARY Correlation Between VFR and FFR |
0.4992 | — |
| SECONDARY Area Under Curve (AUC) Against FFR |
0.8790 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years
- Patient provides written informed consent
- Scheduled for clinically indicated coronary catheterization with the intent to perform physiologic assessment to guide physician clinical course (in lesions with visual % diameter stenosis 40-90%), if clinically indicated
- Subject is undergoing invasive FFR with Adenosine (high-dose intra-coronary (IC) [200 μg for the left and or 100 μg for the right coronary artery] or 140 μg/kg/min for intravenous (IV)) used as hyperemic stimulus
- Clinical presentation with or history of stable angina, unstable angina, or silent ischemia (defined as abnormal stress test or abnormal invasive physiology assessment) that has led to the procedure
General Exclusion Criteria:
- Prior history of myocardial infarction (MI) in the target vessel
- Presence of acute ST Elevation Myocardial Infarction (STEMI)
- Culprit vessel of Non-ST Elevation Myocardial Infarction (NSTEMI)
- TIMI flow 0.03; i.e. Pd and Pa ratio value 1.03, unless physiology measurements are repeated after re-equalization
- Target lesion or significant CAD beyond 60mm from coronary ostium; i.e. not able to clearly image and capture all disease segment with OCT in 1 run
- Incorrectly done or unsuccessful catheter purge and/or contrast flush
- Presence of plaque rupture and/or intravascular hematoma in target vessel (visual % diameter stenosis ≥ 40%)
- Inability to receive intracoronary nitroglycerin prior to OCT or FFR
- Use of flush media other than radiographic contrast
Data sourced from ClinicalTrials.gov (NCT04356027). 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.