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Recruiting NCT07579169

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

No phase Interventional Radiation Exposure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radial Artery Puncture Method for Coronary Angiography and Intervention.
Who it may be relevant to
Registry conditions: Radiation Exposure. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan, South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • Procedure Radial Artery Puncture Method for Coronary Angiography and Intervention
    Radial Artery Puncture Method for Coronary Intervention

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • crossover rate (%) [Time frame: Through procedure completion, up to 24 hours]
  • Fluoroscopy time (min) [Time frame: Through procedure completion, up to 24 hours]
  • Procedure time (min) [Time frame: Through procedure completion, up to 24 hours]
  • volume of contrast medium used (mL) [Time frame: Through procedure completion, up to 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

South Korea · 3 centers
  • Yongin Severance Hospital, Yonsei University — Yongin-si
  • Kyungpook National University College Hospital — Daegu
  • Jeonbuk National University Hospital — Jeonju
Japan · 1 center
  • National Cerebral and Cardiovascular Center, Osaka, Japan — Osaka

Identifiers

NCT: NCT07579169 · 9-2026-0039

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗