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Related Experiment Videos

Catheter sizes for quantitative coronary arteriography

J H Reiber1, W Jukema, A van Boven

  • 1Interuniversity Cardiology Institute of The Netherlands (ICIN), Utrecht.

Catheterization and Cardiovascular Diagnosis
|October 1, 1994
PubMed
Summary

Quantitative coronary arteriography (QCA) calibration can now use manufacturer-stated catheter sizes. This simplifies clinical trials and core laboratory operations by eliminating manual micrometer measurements.

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Area of Science:

  • Cardiovascular Imaging
  • Medical Device Calibration
  • Clinical Trial Methodology

Background:

  • Quantitative coronary arteriography (QCA) relies on contrast catheter outer diameter for calibration.
  • Manufacturer-listed French sizes often do not reflect true outer diameters, necessitating manual measurements.

Purpose of the Study:

  • To assess the variability of actual catheter outer diameters compared to manufacturer specifications.
  • To determine if manufacturer-stated mean values are reliable for QCA calibration.

Main Methods:

  • Measured outer diameters of 2,104 catheters from four manufacturers during the Dutch REGRESS trial.
  • Analyzed measurement variability using precision micrometer data.

Main Results:

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  • Over 97% of catheters (2,048/2,104) showed minimal variability (0.02-0.03 mm), representing a 1% error.
  • A small subset (56 catheters) exhibited slightly higher variability (0.04 mm).

Conclusions:

  • Manufacturer-stated mean catheter values are sufficiently accurate for QCA calibration.
  • This finding streamlines QCA core laboratory operations and clinical trial conduct.