FUnctional diagnoSIs of corONary Stenosis (FUSION)
United States312 participantsStarted 2020-06-26
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 \< Grade 3 at baseline or visible thrombus
* Prior history of coronary artery bypass grafting (CABG)
* Prior heart transplant
* Severe valvular heart disease or history of valve repair or replacement
* Prior history of PCI with stent in target vessel, or target vessel involves in-stent restenosis.
* Target coronary vessel is supplied by major collaterals or is supplying major collaterals to a CTO (chronic total occlusion)
* CTO in the target vessel
* Severe diffuse disease observed in target vessel defined as the presence of diffus…
What they're measuring
1
Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR)
Timeframe: Baseline (pre-procedure) and immediately post-procedure