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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Efficacy; Safety

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 Type: Observational
• Enrollment (Estimated): 3600

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Yongin, Gyeonggi-do, South Korea, 16995
      • Yongcheol Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Evaluate the success rate of coronary angiography and intervention in patients with palpable radial artery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of examination and procedure	Success rate of examination and procedure	through procedure completion, up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications of the puncture region	complications of the puncture region	the first outpatient visit after discharge
the success rate of the puncture	the success rate of the puncture	through procedure completion, up to 24 hours
puncture time	puncture time	through procedure completion, up to 24 hours

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Study Director: Yongcheol Kim, MD, PhD, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 9-2021-0048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No