Radiation ExposureDOSENCT05702060
Randomized Comparison of Radiation Exposure to Operators in Coronary Intervention Between Right Radial and Left DRA
A study testing Radial Artery Puncture Method for Coronary Angiography and Intervention in people with Radiation Exposure, run by Yonsei University at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Radiation Exposure
- What is being tested?
- Radial Artery Puncture Method for Coronary Angiography and Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 5 Jan 2023to 22 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 years or older
- Patients scheduled for coronary angiography and intervention
Who cannot join
- 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
Show all 9Show fewer
- When an ergonovine provocation test is required
- When the patient refuses to consent to the study
- a pregnant or nursing woman
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do, CVFP+R9
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 8WXW+93
Yongin Severance Hospital
Yongin, Gyeonggi-do, 74CX+97
About this study
Official title: 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.
Read the 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.
- Conditions
- Radiation Exposure
- Being tested
- Radial Artery Puncture Method for Coronary Angiography and Intervention
- Keywords
- DOSE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Artery Puncture Method for Coronary Angiography and InterventionProcedure or surgery
Radial Artery Puncture Method for Coronary Angiography and Intervention
| Study group | Role | What they receive |
|---|---|---|
| Left distal radial artery approach | Experimental | Coronary angiography and intervention were performed using the left distal radial artery approach Receives: 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 Receives: Procedure: Radial Artery Puncture Method for Coronary Angiography and Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation exposure examination
Radiation exposure for surgeons in the case of the left distal radial artery approach and the right radial artery approach, respectively
Measured: Through procedure completion, up to 24 hours
Secondary outcomes (6)
Fluoroscopy time
Fluoroscopy time
Measured: Through procedure completion, up to 24 hours
Corrected by X-ray dose Radiation exposure of surgeons
Corrected by X-ray dose Radiation exposure of surgeons
Measured: Through procedure completion, up to 24 hours
Corrected by X-ray dose Radiation
Corrected by X-ray dose Radiation
Measured: Through procedure completion, up to 24 hours
Hemostasis time
Hemostasis time
Measured: Through procedure completion, up to 24 hours
Procedure success rate
Procedure success rate
Measured: Through procedure completion, up to 24 hours
Amount of contrast agent used
Amount of contrast agent used
Measured: Through procedure completion, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start5 Jan 2023
- Primary completion31 Mar 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ExposureStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Conventional Right Radial Artery Approach and Left Distal Radial Artery Approach for Coronary Angiography and Interventions
- Masking
- None (open label)
- Enrolment
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Myung In Pharm
- Responsible party
- Principal investigator, Yongcheol Kim, Yonsei University
- Investigators
- Yongcheol Kim, MD, PhD, Study director, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702060
- Sponsor's protocol ID
- 9-2022-0141
- Acronym
- DOSE
- Status last verified
- Nov 2025
- First submitted
- 6 Jan 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05702060
- Acronym / sponsor ID
- DOSE / 9-2022-0141
- Conditions
- Radiation Exposure
- Keywords
- DOSE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Myung In Pharm
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Conventional Right Radial Artery Approach and Left Distal Radial Artery Approach for Coronary Angiography and Interventions
| Arm | Type | Receives |
|---|---|---|
| Left distal radial artery approach | Experimental | Procedure: Radial Artery Puncture Method for Coronary Angiography and InterventionCoronary angiography and intervention were performed using the left distal radial artery approach |
| Right Radial Artery Approach | Active comparator | Procedure: Radial Artery Puncture Method for Coronary Angiography and InterventionCoronary angiography and intervention were performed using the Right Radial Artery Approach |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 20 years or older
- Patients scheduled for coronary angiography and intervention
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial Artery Puncture Method for Coronary Angiography and InterventionRadial Artery Puncture Method for Coronary Angiography and Intervention | Procedure or surgery | Left distal radial artery approach, Right Radial Artery Approach |
Primary outcome
Radiation exposure examination
Time frame: 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
6 secondary outcomes
Fluoroscopy time
Time frame: Through procedure completion, up to 24 hours
Corrected by X-ray dose Radiation exposure of surgeons
Time frame: Through procedure completion, up to 24 hours
Corrected by X-ray dose Radiation
Time frame: Through procedure completion, up to 24 hours
Hemostasis time
Time frame: Through procedure completion, up to 24 hours
Procedure success rate
Time frame: Through procedure completion, up to 24 hours
Amount of contrast agent used
Time frame: Through procedure completion, up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongcheol Kim, MD, PhD study director
Severance Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Artery Puncture Method for Coronary Angiography and Intervention in people with Radiation Exposure, run by Yonsei University at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation exposure examination (time frame: Through procedure completion, up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.