SafetyNCT05776550
Safety and Efficacy of Distal Radial Access (SAFE-BOX)
An observational study of Safety and Efficacy, run by Yonsei University at 1 site in South Korea.
Trial summary
A Prospective Registry to assess the Safety and Efficacy of Distal Radial Approach Read more about this study
- Who is it for?
- Ages 20 years and older
- How many people
- 3,600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jan 2023to 31 Dec 2026
- Phase
- Observational
- 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
Study population: Evaluate the success rate of coronary angiography and intervention in patients with palpable radial artery
Who may be able to join
- Patients over 20 years of age
- Patients requiring coronary angiography or intervention
- Patients with palpable distant radial artery
Who cannot join
- Patients with distant radial artery too small or not palpable
- Pregnant women
- Patients not appropriate for the researcher to judge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Registry to Assess the Safety and Efficacy of Distal Radial Access (SAFE-BOX)
A Prospective Registry to assess the Safety and Efficacy of Distal Radial Approach
Read the detailed description
Anaphylactic radial approach is now recognized as a basic technique in coronary artery procedures. The main advantage is increased stability due to the reduction of massive bleeding and increased patient comfort because it can move immediately after the procedure. The operator prefers access to the right radial artery because of the comfort of performing the procedure on the right side of the patient. However, the operator should frequently replace it with a left radial artery approach for various reasons, including 1) closure of the right radial artery, 2) difficulty accessing the coronary artery due to severe gambling of the radial artery, and 3) hemodialysis of the right radial artery.
As for prognosis, the left and right radial artery approaches are similar. However, the left radial artery approach is bound to experience anthropological discomfort in which the operator has to lean toward the patient. An easy solution is the approach from the anatomical left snuff box located on the back of the hand to the distal radial artery. Recently, the left snuffbox approach has been reported, and attempts are increasing in many countries. However, it is true that there is still a difference in diameter of the radial artery through the distant radial artery approach and concerns about percutaneous coronary intervention through this compared to the classical radial artery approach. Recent studies have published studies on the stability and effectiveness of distant radial artery approaches, but they are still small, and studies on specific subgroups are very scarce. Furthermore, data on the current status and performance in Korea so far is very scarce. Therefore, through this study, we would like to systematically collect and analyze data on the status and performance of the approach through the distant radial artery approach to find out the stability and effectiveness of various patient groups, treatment methods.
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of examination and procedure
Success rate of examination and procedure
Measured: through procedure completion, up to 24 hours
Secondary outcomes (3)
the success rate of the puncture
the success rate of the puncture
Measured: through procedure completion, up to 24 hours
puncture time
puncture time
Measured: through procedure completion, up to 24 hours
complications of the puncture region
complications of the puncture region
Measured: the first outpatient visit after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start5 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongcheol Kim, Yonsei University
- Investigators
- Yongcheol Kim, MD, PhD, Study director, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776550
- Sponsor's protocol ID
- 9-2021-0048
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry to Assess the Safety and Efficacy of Distal Radial Access (SAFE-BOX)
- ClinicalTrials.gov ID
- NCT05776550
- Acronym / sponsor ID
- 9-2021-0048
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Mar 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.
A Prospective Registry to assess the Safety and Efficacy of Distal Radial Approach
Detailed description
Anaphylactic radial approach is now recognized as a basic technique in coronary artery procedures. The main advantage is increased stability due to the reduction of massive bleeding and increased patient comfort because it can move immediately after the procedure. The operator prefers access to the right radial artery because of the comfort of performing the procedure on the right side of the patient. However, the operator should frequently replace it with a left radial artery approach for various reasons, including 1) closure of the right radial artery, 2) difficulty accessing the coronary artery due to severe gambling of the radial artery, and 3) hemodialysis of the right radial artery.
As for prognosis, the left and right radial artery approaches are similar. However, the left radial artery approach is bound to experience anthropological discomfort in which the operator has to lean toward the patient. An easy solution is the approach from the anatomical left snuff box located on the back of the hand to the distal radial artery. Recently, the left snuffbox approach has been reported, and attempts are increasing in many countries. However, it is true that there is still a difference in diameter of the radial artery through the distant radial artery approach and concerns about percutaneous coronary intervention through this compared to the classical radial artery approach. Recent studies have published studies on the stability and effectiveness of distant radial artery approaches, but they are still small, and studies on specific subgroups are very scarce. Furthermore, data on the current status and performance in Korea so far is very scarce. Therefore, through this study, we would like to systematically collect and analyze data on the status and performance of the approach through the distant radial artery approach to find out the stability and effectiveness of various patient groups, treatment methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Evaluate the success rate of coronary angiography and intervention in patients with palpable radial artery
Key inclusion criteria (3 listed)
- Patients over 20 years of age
- Patients requiring coronary angiography or intervention
- Patients with palpable distant radial artery
Key exclusion criteria (3 listed)
- Patients with distant radial artery too small or not palpable
- Pregnant women
- Patients not appropriate for the researcher to judge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Success rate of examination and procedure
Time frame: through procedure completion, up to 24 hours
Success rate of examination and procedure
3 secondary outcomes
the success rate of the puncture
Time frame: through procedure completion, up to 24 hours
puncture time
Time frame: through procedure completion, up to 24 hours
complications of the puncture region
Time frame: the first outpatient visit after discharge
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 24 Apr 2026.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety and Efficacy, run by Yonsei University at 1 site 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
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?
Success rate of examination and procedure (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 24 Apr 2026.