Randomized Comparison of Radiation Exposure to Operators in Coronary Intervention Between Right Radial and Left DRA

NCT05702060 | Completed

• 1 other identifier: 9-2022-0141
• Study Type: interventional
• Target: 1,010
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to show that the radiation exposure of the left distal radial artery approach is superior to the conventional right radial artery approach in terms of less radiation exposure.

Conditions

Radiation Exposure

Keywords

DOSE

Outcome Measures

Primary Outcomes (1)

• Radiation exposure examination

  Radiation exposure for surgeons in the case of the left distal radial artery approach and the right radial artery approach, respectively

  Through procedure completion, up to 24 hours

Secondary Outcomes (6)

• Fluoroscopy time

  Through procedure completion, up to 24 hours

• Corrected by X-ray dose Radiation exposure of surgeons

  Through procedure completion, up to 24 hours

• Corrected by X-ray dose Radiation

  Through procedure completion, up to 24 hours

• Hemostasis time

  Through procedure completion, up to 24 hours

• Procedure success rate

  Through procedure completion, up to 24 hours

Study Arms (2)

Left distal radial artery approach

EXPERIMENTAL

Coronary angiography and intervention were performed using the left distal radial artery approach

Procedure: Radial Artery Puncture Method for Coronary Angiography and Intervention

Right Radial Artery Approach

ACTIVE COMPARATOR

Coronary angiography and 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 Intervention PROCEDURE

Radial Artery Puncture Method for Coronary Angiography and Intervention

Left distal radial artery approach; Right Radial Artery Approach

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20 years or older
• Patients scheduled for coronary angiography and intervention

You may not qualify if:

• When the pulse of the Left distal radial artery cannot be palpated
• When the pulse of the right conventional radial artery cannot be palpated
• In case of arteriovenous fistula
• Acute myocardial infarction (AMI) patients
• In case femoral artery access must be performed (state of shock, etc.)
• In case of atrioventricular block
• When an ergonovine provocation test is required
• When the patient refuses to consent to the study
• a pregnant or nursing woman

Sponsors & Collaborators

• Yonsei University: lead
• Myung In Pharm: collaborator

Study Sites (3)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 8WXW+93, South Korea

Location

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, CVFP+R9, South Korea

Location

Yongin Severance Hospital

Yongin, Gyeonggi-do, 74CX+97, South Korea

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Yongcheol Kim, MD, PhD

  Severance Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Conventional Right Radial Artery Approach and Left Distal Radial Artery Approach for Coronary Angiography and Interventions

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 27, 2023
• Study Start: January 5, 2023
• Primary Completion: March 31, 2025
• Study Completion: July 22, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)