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

Comparison of raDiatiOn Exposure to Operators in Coronary Angiography and Percutaneous Coronary Intervention Between Right Conventional and Left Distal Radial artEry Approach: Multicenter, Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Radiation Exposure
• Intervention / Treatment: Procedure: Radial Artery Puncture Method for Coronary Angiography and Intervention

Detailed Description

The conventional radial approach is now recognized as the basic technique in coronary artery surgery. Compared to the femoral artery access, the main advantage is the increased stability due to the reduction of massive bleeding. Due to these advantages, recent guidelines recommend the conventional radial approach as the basic approach for all acute myocardial infarction (AMI) cases with or without ST-segment elevation. In particular, in the case of ST-segment elevation myocardial infarction (STEMI), new antiplatelet agents such as Ticagrelor and Prasugrel and strong antiplatelet agents such as Glycoprotein inhibitors have been used to prevent major vascular complications. For these many operators, primary percutaneous coronary intervention (PCI) through the radial artery is recommended. At this time, the operator prefers the right radial artery approach because of the comfort of performing the procedure on the patient's right side. However, the operator sometimes has to substitute the left radial artery or femoral artery access due to difficulty in manipulating the catheter due to severe tortuousness of the right subclavian artery. Although the left radial artery approach requires less operation time and radiographic imaging time due to less tortuousness of the left subclavian artery, the right conventional radial approach is still preferred due to the ergonomic inconvenience of having to lean toward the patient. Patients undergoing coronary angiography (CAG) were randomly assigned to the left snuffbox approach and the right conventional radial approach, and the surgeons' radiation exposure between the two approaches was evaluated and compared.

• Study Type: Interventional
• Enrollment (Actual): 1010
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Gangwon-do
    • Wŏnju, Gangwon-do, South Korea, 8WXW+93
      • WonJu Severance Christian Hospital
  • Gyeonggi-do
    • Gwangmyeong, Gyeonggi-do, South Korea, CVFP+R9
      • Chung-Ang University Gwangmyeong Hospital
    • Yongin, Gyeonggi-do, South Korea, 74CX+97
      • Yongin Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients aged 20 years or older
2. Patients scheduled for coronary angiography and intervention

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Left distal radial artery approach; Coronary angiography and 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 Angiography and Intervention
Active Comparator: Right Radial Artery Approach; Coronary angiography and 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 Angiography and Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected by X-ray dose Radiation exposure of surgeons	Corrected by X-ray dose Radiation exposure of surgeons	Through procedure completion, up to 24 hours
Hemostasis time	Hemostasis time	Through procedure completion, up to 24 hours
Procedure success rate	Procedure success rate	Through procedure completion, up to 24 hours
Fluoroscopy time	Fluoroscopy time	Through procedure completion, up to 24 hours
Corrected by X-ray dose Radiation	Corrected by X-ray dose Radiation	Through procedure completion, up to 24 hours
Amount of contrast agent used	Amount of contrast agent used	Through procedure completion, up to 24 hours

Collaborators and Investigators

• Sponsor: Yonsei University
• Collaborators: Myung In Pharm
• Investigators: Study Director: Yongcheol Kim, MD, PhD, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): July 22, 2025

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: DOSE
• Additional Relevant MeSH Terms: Investigative Techniques; Methods
• Other Study ID Numbers: 9-2022-0141

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
• product manufactured in and exported from the U.S.: No