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

Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776550
• Other study ID #: 9-2021-0048
• Status: Recruiting
• Start date: January 5, 2023
• Est. completion date: May 20, 2026

Study information

• Verified date: March 2024
• Source: Yonsei University
• Contact: Yongcheol Kim, MD, PhD
• Phone: +823151898967
• Email: yongcheol[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A Prospective Registry to assess the Safety and Efficacy of Distal Radial Approach

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3600
• Est. completion date: May 20, 2026
• Est. primary completion date: May 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Efficacy
• Safety

Locations

Country	Name	City	State
Korea, Republic of	Yongcheol Kim	Yongin	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of examination and procedure	Success rate of examination and procedure	through procedure completion, up to 24 hours
Secondary	the success rate of the puncture	the success rate of the puncture	through procedure completion, up to 24 hours
Secondary	puncture time	puncture time	through procedure completion, up to 24 hours
Secondary	complications of the puncture region	complications of the puncture region	the first outpatient visit after discharge