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Safety and Efficacy of Distal Radial Access (SAFE-BOX)

A Prospective Registry to Assess the Safety and Efficacy of Distal Radial Access (SAFE-BOX)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05776550
Enrollment
3600
Registered
2023-03-20
Start date
2023-01-05
Completion date
2026-12-31
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficacy, Safety

Brief summary

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.

Interventions

None listed

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients over 20 years of age 2. Patients requiring coronary angiography or intervention 3. Patients with palpable distant radial artery

Exclusion criteria

1. Patients with distant radial artery too small or not palpable 2. Pregnant women 3. Patients not appropriate for the researcher to judge

Design outcomes

Primary

MeasureTime frameDescription
Success rate of examination and procedurethrough procedure completion, up to 24 hoursSuccess rate of examination and procedure

Secondary

MeasureTime frameDescription
the success rate of the puncturethrough procedure completion, up to 24 hoursthe success rate of the puncture
puncture timethrough procedure completion, up to 24 hourspuncture time
complications of the puncture regionthe first outpatient visit after dischargecomplications of the puncture region

Countries

South Korea

Contacts

STUDY_DIRECTORYongcheol Kim, MD, PhD

Severance Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026