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NCT Number: NCT07579169

Comparison of Operator Radiation Exposure During Percutaneous Coronary Intervention Between Left Distal and Right Conventional Radial Access

This study aims to compare the operator's radiation exposure between left distal radial access (LDRA) and right transradial access (RTRA) in patients undergoing percutaneous coronary intervention (PCI).

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Key information

Conditions

Radiation Exposure

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cerebral and Cardiovascular Center, Osaka, Japan, Osaka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 19 years or older
  • Patients scheduled for PCI

Exclusion criteria

  • Non-palpable left distal radial artery pulse
  • Non-palpable right radial artery pulse
  • Presence of arteriovenous fistula
  • Need for femoral access as determined by the investigator
  • Refusal to provide informed consent
  • Pregnant or breastfeeding women

Treatment and study plan

Radial Artery Puncture Method for Coronary Angiography and Intervention

Procedure

Radial Artery Puncture Method for Coronary Intervention

Primary outcomes

  1. Cumulative operator radiation exposure during PCI (µSv) with a set of 3 radiation detection dosimeters on left wrist, left head, and left chest

    Time frame: Through procedure completion, up to 24 hours

    To compare the cumulative radiation dose (µSv) received by the operator between the left distal radial artery approach and the right radial artery approach during PCI. Radiation exposure is measured using a set of three radiation detection dosimeters placed on the operator's left wrist, left head, and left chest.

Secondary outcomes

  1. crossover rate (%)

    Time frame: Through procedure completion, up to 24 hours

    The percentage of participants who required a change in the initial arterial access site to a different site to successfully complete the PCI procedure.

  2. Fluoroscopy time (min)

    Time frame: Through procedure completion, up to 24 hours

    Total duration of exposure to fluoroscopy during the PCI procedure, measured in minutes.

  3. Procedure time (min)

    Time frame: Through procedure completion, up to 24 hours

    Total time from the first skin incision or needle puncture to the removal of the last catheter/sheath, measured in minutes.

  4. volume of contrast medium used (mL)

    Time frame: Through procedure completion, up to 24 hours

    Total volume of radiopaque contrast media administered to the participant during the procedure, measured in milliliters (mL).

Study contacts

Contact information is provided by the study sponsor or research team.

Yongcheol Kim, MD, PhD

CONTACT

[email protected]

+823151898967

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Yonsei University Yongin Severance Hospital

Registry information

Official study title

Comparison of Operator Radiation Exposure During Percutaneous Coronary Intervention Between Left Distal and Right Conventional Radial Access: A Multicenter, Randomized Trial

Acronym: DOSE-PCI

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 11, 2026
Registry last updated
Jul 8, 2026

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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