Radiation ExposureDOSE-PCINCT07579169
Comparison of Operator Radiation Exposure During Percutaneous Coronary Intervention Between Left Distal and Right Conventional Radial Access
A study testing Radial Artery Puncture Method for Coronary Angiography and Intervention in people with Radiation Exposure, run by Yonsei University at 4 sites in 2 countries.
Trial summary
This study aims to compare the operator's radiation exposure between left distal radial access (LDRA) and right transradial access (RTRA) in patients undergoing percutaneous coronary intervention (PCI). 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
- 748 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 18 Jun 2026to 21 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years or older
- Patients scheduled for PCI
Who cannot join
- Non-palpable left distal radial artery pulse
- Non-palpable right radial artery pulse
- Presence of arteriovenous fistula
- Need for femoral access as determined by the investigator
- Refusal to provide informed consent
- Pregnant or breastfeeding women
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
South Korea3 sites, 3 recruiting
- Not yet recruiting
Kyungpook National University College Hospital
Daegu, Gyeongsangnam-do, 136-705
Namkyun kim, MD, kimnamkyun81@gmail.com, kimnamkyun81@gmail.com
- Not yet recruiting
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Yisik Kim, MD, PhD, dr.kimesik@gmail.com, dr.kimesik@gmail.com
- Recruiting
Yongin Severance Hospital, Yonsei University
Yongin-si, Gyeonggi-do, 16995
Yongcheol Kim, MD, +823151898967, yongcheol@yuhs.ac
Japan1 site, 1 recruiting
- Not yet recruiting
National Cerebral and Cardiovascular Center, Osaka, Japan
Osaka
Satoshi Honda, MD, satoshi.honda@ncvc.go.jp, satoshi.honda@ncvc.go.jp
About this study
Official title: Comparison of Operator Radiation Exposure During Percutaneous Coronary Intervention Between Left Distal and Right Conventional Radial Access: A Multicenter, Randomized Trial
This study aims to compare the operator's radiation exposure between left distal radial access (LDRA) and right transradial access (RTRA) in patients undergoing percutaneous coronary intervention (PCI).
- Conditions
- Radiation Exposure
- Being tested
- Radial Artery Puncture Method for Coronary Angiography and Intervention
- Keywords
- DOSE-PCI
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 Intervention
| Study group | Role | What they receive |
|---|---|---|
| Left distal radial artery approach | Other | Coronary 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 | Other | Coronary 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.
Cumulative operator radiation exposure during PCI (µSv) with a set of 3 radiation detection dosimeters on left wrist, left head, and left chest
To compare the cumulative radiation dose (µSv) received by the operator between the left distal radial artery approach and the right radial artery approach during PCI. Radiation exposure is measured using a set of three radiation detection dosimeters placed on the operator's left wrist, left head, and left chest.
Measured: Through procedure completion, up to 24 hours
Secondary outcomes (4)
crossover rate (%)
The percentage of participants who required a change in the initial arterial access site to a different site to successfully complete the PCI procedure.
Measured: Through procedure completion, up to 24 hours
Fluoroscopy time (min)
Total duration of exposure to fluoroscopy during the PCI procedure, measured in minutes.
Measured: Through procedure completion, up to 24 hours
Procedure time (min)
Total time from the first skin incision or needle puncture to the removal of the last catheter/sheath, measured in minutes.
Measured: Through procedure completion, up to 24 hours
volume of contrast medium used (mL)
Total volume of radiopaque contrast media administered to the participant during the procedure, measured in milliliters (mL).
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 posted11 May 2026
- Study start18 Jun 2026
- Primary completion21 Apr 2029 (estimated)
- Study completion21 Apr 2029 (estimated)
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 versus Left Distal Radial Approach for Percutaneous Coronary Interventions
- Masking
- None (open label)
- Enrolment
- 748 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Yonsei University Yongin Severance Hospital
- Responsible party
- Principal investigator, Yongcheol Kim, Yonsei University
- Investigators
- Yongcheol Kim, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579169
- Sponsor's protocol ID
- 9-2026-0039
- Acronym
- DOSE-PCI
- Status last verified
- Jun 2026
- First submitted
- 4 May 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Operator Radiation Exposure During Percutaneous Coronary Intervention Between Left Distal and Right Conventional Radial Access: A Multicenter, Randomized Trial
- ClinicalTrials.gov ID
- NCT07579169
- Acronym / sponsor ID
- DOSE-PCI / 9-2026-0039
- Conditions
- Radiation Exposure
- Keywords
- DOSE-PCI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 748 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Yonsei University Yongin Severance Hospital
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 21 Apr 2029 (estimated)
- Study completion
- 21 Apr 2029 (estimated)
- First posted
- 11 May 2026 (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.
This study aims to compare the operator's radiation exposure between left distal radial access (LDRA) and right transradial access (RTRA) in patients undergoing percutaneous coronary intervention (PCI).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Conventional Right Radial versus Left Distal Radial Approach for Percutaneous Coronary Interventions
| Arm | Type | Receives |
|---|---|---|
| Left distal radial artery approach | Other | Procedure: Radial Artery Puncture Method for Coronary Angiography and InterventionCoronary intervention were performed using the left distal radial artery approach |
| Right Radial Artery Approach | Other | Procedure: Radial Artery Puncture Method for Coronary Angiography and InterventionCoronary 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 19 years or older
- Patients scheduled for PCI
Key exclusion criteria (6 listed)
- Non-palpable left distal radial artery pulse
- Non-palpable right radial artery pulse
- Presence of arteriovenous fistula
- Need for femoral access as determined by the investigator
- Refusal to provide informed consent
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 Intervention | Procedure or surgery | Left distal radial artery approach, Right Radial Artery Approach |
Primary outcome
Cumulative operator radiation exposure during PCI (µSv) with a set of 3 radiation detection dosimeters on left wrist, left head, and left chest
Time frame: Through procedure completion, up to 24 hours
To compare the cumulative radiation dose (µSv) received by the operator between the left distal radial artery approach and the right radial artery approach during PCI. Radiation exposure is measured using a set of three radiation detection dosimeters placed on the operator's left wrist, left head, and left chest.
4 secondary outcomes
crossover rate (%)
Time frame: Through procedure completion, up to 24 hours
Fluoroscopy time (min)
Time frame: Through procedure completion, up to 24 hours
Procedure time (min)
Time frame: Through procedure completion, up to 24 hours
volume of contrast medium used (mL)
Time frame: Through procedure completion, up to 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- 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.
Yongcheol Kim, MD, PhD principal investigator
Severance Hospital
4 sites in 2 countries: 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 4 sites in 2 countries.
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 6 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea, Japan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongcheol Kim, MD, PhD (+823151898967, yongcheol@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative operator radiation exposure during PCI (µSv) with a set of 3 radiation detection dosimeters on left wrist, left head, and left chest (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 8 Jul 2026.