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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorYonsei University

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 19 years or older

Patients scheduled for PCI

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radial Artery Puncture Method for Coronary Angiography and Intervention

    Procedure/Surgery

    Radial Artery Puncture Method for Coronary Intervention

Treatment groups

748 Participants
are divided into 2 treatment groups
Group A: Left distal radial artery approachOther 1 intervention
Group B: Right Radial Artery ApproachOther 1 intervention

Trial outcomes

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

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.

Time frame
Through procedure completion, up to 24 hours

Secondary outcomes

1

crossover rate (%)

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

Time frame
Through procedure completion, up to 24 hours
2

Fluoroscopy time (min)

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

Time frame
Through procedure completion, up to 24 hours
3

Procedure time (min)

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

Time frame
Through procedure completion, up to 24 hours
4

volume of contrast medium used (mL)

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

Time frame
Through procedure completion, up to 24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yonsei University

Lead sponsor

Yonsei University Yongin Severance Hospital

Collaborator