An observational study in Coronary Artery Disease, sponsored by Onze Lieve Vrouw Hospital. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-30.
Sponsored by Onze Lieve Vrouw Hospital · Observational
Registry of patients undergoing invasive fractional flow reserve measurement using a motorized device.
A prospective registry of patients undergoing clinically indicated coronary angiography with fractional flow reserve evaluation for vessels with intermediate coronary lesions defined as visual diameter stenosis between 30% and 70%. A motorized fractional flow reservepullback evaluation will be performed at the discretion of the operators. The objective of the present study is to describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 117 is below the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
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Patients undergoing clinically indicated coronary angiography and fractional flow reserve evaluation for intermediate coronary lesions defined as visual diameter stenosis between 30% and 70%
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Exclusion Criteria:
A pullback device (Volcano R 100, San Diego CA, USA), adapted to grip the coronary pressure wire (PressureWire X, St Jude Medical, Minneapolis, USA), set at a speed of 1 mm/sec to pullback the pressure-wire until the tip of the guiding catheter during continued pressure recording.
Physiological Patterns of Coronary Artery Disease (i.e. focal, diffuse or combined)
Describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease. A pullback device adapted to grip the coronary pressure wire with a speed of 1 mm/sec during continued pressure recording will be used. A fractional flow reserve value every 100 microns will be extracted from the pressure tracing and plotted against the length to generate a pullback curve. Fractional flow reserve will be defined as the ratio of the moving average of the proximal and distal coronary pressures. The patterns of physiological disease will be classified as focal or diffuse according to the visual inspection of the fractional flow reserve pullback curve. The patterns of coronary artery disease will be reported as a focal, diffuse or combined pattern (i.e. focal and diffuse).
Time frame: Immediate post-procedure. No follow-up is schedule for this trial.
Classification of the physiological patterns of coronary artery disease using a quantitative metric
Based on the data obtained using the fractional flow reserve pullbacks and conventional coronary angiography a quantitative classification of the physiological pattern of coronary artery disease based on the functional contribution of the epicardial lesion (i.e. lesion-related pressure drop) with respect to the total vessel fractional flow reserve will be explored.
Time frame: Immediate post-procedure. No follow-up is schedule for this trial.
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Onze Lieve Vrouw Hospital