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OpenTrials
Completed

NCT Number: NCT03824600

Physiological Patterns of Coronary Artery Disease

Registry of patients undergoing invasive fractional flow reserve measurement using a motorized device.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OLV Aalst, Aalst, West Flanders, Belgium

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable coronary artery disease

Exclusion criteria

  • acute coronary syndromes
  • previous coronary artery bypass grafting
  • significant valvular disease
  • severe obstructive pulmonary disease or asthma bronchial
  • severe tortuosity or severe calcification

Treatment and study plan

Fractional Flow Reserve Motorized Pullback

Diagnostic Test

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.

Primary outcomes

  1. Physiological Patterns of Coronary Artery Disease (i.e. focal, diffuse or combined)

    Time frame: Immediate post-procedure. No follow-up is schedule for this trial.

    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).

Other outcomes

  1. Classification of the physiological patterns of coronary artery disease using a quantitative metric

    Time frame: Immediate post-procedure. No follow-up is schedule for this trial.

    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.

Sponsors and collaborators

Lead sponsor

Onze Lieve Vrouw Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 31, 2019
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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