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

NCT ID: NCT05702060

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1010 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-05

Study Completion Date

2025-07-22

Brief Summary

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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

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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.

Conditions

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Radiation Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Conventional Right Radial Artery Approach and Left Distal Radial Artery Approach for Coronary Angiography and Interventions
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Left distal radial artery approach

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

Group Type EXPERIMENTAL

Radial Artery Puncture Method for Coronary Angiography and Intervention

Intervention Type PROCEDURE

Radial Artery Puncture Method for Coronary Angiography and Intervention

Right Radial Artery Approach

Coronary angiography and intervention were performed using the Right Radial Artery Approach

Group Type ACTIVE_COMPARATOR

Radial Artery Puncture Method for Coronary Angiography and Intervention

Intervention Type PROCEDURE

Radial Artery Puncture Method for Coronary Angiography and Intervention

Interventions

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Radial Artery Puncture Method for Coronary Angiography and Intervention

Radial Artery Puncture Method for Coronary Angiography and Intervention

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Myung In Pharm

UNKNOWN

Sponsor Role collaborator

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Yongcheol Kim

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yongcheol Kim, MD, PhD

Role: STUDY_DIRECTOR

Severance Hospital

Locations

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Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, South Korea

Site Status

Yongin Severance Hospital

Yongin, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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9-2022-0141

Identifier Type: -

Identifier Source: org_study_id

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