NCT07579169

Brief Summary

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).

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
748

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
2 countries

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2029

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

2.9 years

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Radiation Exposure

Keywords

DOSE-II PCI

Outcome Measures

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.

    Through procedure completion, up to 24 hours

Secondary Outcomes (4)

  • crossover rate (%)

    Through procedure completion, up to 24 hours

  • Fluoroscopy time (min)

    Through procedure completion, up to 24 hours

  • Procedure time (min)

    Through procedure completion, up to 24 hours

  • volume of contrast medium used (mL)

    Through procedure completion, up to 24 hours

Study Arms (2)

Left distal radial artery approach

OTHER

Coronary intervention were performed using the left distal radial artery approach

Procedure: Radial Artery Puncture Method for Coronary Angiography and Intervention

Right Radial Artery Approach

OTHER

Coronary intervention were performed using the Right Radial Artery Approach

Procedure: Radial Artery Puncture Method for Coronary Angiography and Intervention

Interventions

Radial Artery Puncture Method for Coronary Angiography and InterventionPROCEDURE

Radial Artery Puncture Method for Coronary Intervention

Left distal radial artery approachRight Radial Artery Approach

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

National Cerebral and Cardiovascular Center, Osaka, Japan

Osaka, Japan

Location

Yongin Severance Hospital, Yonsei University

Yongin-si, Gyeonggi-do, 16995, South Korea

Location

Kyungpook National University College Hospital

Daegu, Gyeongsangnam-do, 136-705, South Korea

Location

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Yongcheol Kim, MD, PhD

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongcheol Kim, MD, PhD

CONTACT

+823151898967yongcheol@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Conventional Right Radial versus Left Distal Radial Approach for Percutaneous Coronary Interventions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yonsei University

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 11, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

April 21, 2029

Study Completion (Estimated)

April 21, 2029

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)KR(3)