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

NCT ID: NCT05776550

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2026-05-20

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.

Conditions

Safety; Efficacy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Yongcheol Kim

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongcheol Kim, MD, PhD

Role: STUDY_DIRECTOR

Severance Hospital

Locations

Yongcheol Kim

Yongin, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Yongcheol Kim, MD, PhD

Role: CONTACT

yongcheol@yuhs.ac

+823151898967

Ji Woong Roh, MD, PhD

Role: CONTACT

NOMGALDA@yuhs.ac

+823151898792

Facility Contacts

Yongcheol Kim, MD

Role: primary

yongcheol@yuhs.ac

+823151898967

Other Identifiers

9-2021-0048

Identifier Type: -

Identifier Source: org_study_id