Comparison of Operator Radiation Exposure During Percutaneous Coronary Intervention Between Left Distal and Right Conventional Radial Access (DOSE-PCI)

May 21, 2026 updated by: Yongcheol Kim, Yonsei University

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

748

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Osaka, Japan
        • National Cerebral and Cardiovascular Center, Osaka, Japan
        • Contact:
  • South Korea
    • Gyeonggi-do
      • Yongin-si, Gyeonggi-do, South Korea, 16995
        • Yongin Severance Hospital, Yonsei University
        • Contact:
    • Gyeongsangnam-do
      • Daegu, Gyeongsangnam-do, South Korea, 136-705
        • Kyungpook National University College Hospital
        • Contact:
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, South Korea, 54907
        • Jeonbuk National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged 19 years or older
  2. Patients scheduled for PCI

Exclusion Criteria:

  1. Non-palpable left distal radial artery pulse
  2. Non-palpable right radial artery pulse
  3. Presence of arteriovenous fistula
  4. Need for femoral access as determined by the investigator
  5. Refusal to provide informed consent
  6. Pregnant or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Left distal radial artery approach
Coronary intervention were performed using the left distal radial artery approach
Procedure: Radial Artery Puncture Method for Coronary Angiography and Intervention
Radial Artery Puncture Method for Coronary Intervention
Other: Right Radial Artery Approach
Coronary intervention were performed using the Right Radial Artery Approach
Procedure: Radial Artery Puncture Method for Coronary Angiography and Intervention
Radial Artery Puncture Method for Coronary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through procedure completion, up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through procedure completion, up to 24 hours
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.
Through procedure completion, up to 24 hours
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.
Through procedure completion, up to 24 hours
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).
Through procedure completion, up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Yongcheol Kim, MD, PhD, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

April 21, 2029

Study Completion (Estimated)

April 21, 2029

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9-2026-0039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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