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

Not Applicable

Active, not recruiting

• Conditions: Radiation Exposure
• Interventions: Procedure: Radial Artery Puncture Method for Coronary Angiography and Intervention

• Registration Number: NCT05702060
• Lead Sponsor: Yonsei University

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.

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 Timeline

• Study Start: 2023-01-05
• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-12-05
• Study Completion: 2025-12-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1010

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left distal radial artery approach	Radial Artery Puncture Method for Coronary Angiography and Intervention	Coronary angiography and intervention were performed using the left distal radial artery approach
Right Radial Artery Approach	Radial Artery Puncture Method for Coronary Angiography and Intervention	Coronary angiography and intervention were performed using the Right Radial Artery Approach

Primary Outcome Measures

Name	Time	Method
Radiation exposure examination	Through procedure completion, up to 24 hours	Radiation exposure for surgeons in the case of the left distal radial artery approach and the right radial artery approach, respectively

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Gangwon-do, Korea, Republic of

Chung-Ang University Gwangmyeong Hospital; 🇰🇷 Gwangmyeong, Gyeonggi-do, Korea, Republic of

Yongin Severance Hospital; 🇰🇷 Yongin, Gyeonggi-do, Korea, Republic of