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Active, Not Recruiting

NCT Number: NCT05776550

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yongcheol Kim

Yongin, Gyeonggi-do, 16995, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 20 years of age
  • Patients requiring coronary angiography or intervention
  • Patients with palpable distant radial artery

Exclusion criteria

  • Patients with distant radial artery too small or not palpable
  • Pregnant women
  • Patients not appropriate for the researcher to judge

Treatment and study plan

Primary outcomes

  1. Success rate of examination and procedure

    Time frame: through procedure completion, up to 24 hours

    Success rate of examination and procedure

Secondary outcomes

  1. the success rate of the puncture

    Time frame: through procedure completion, up to 24 hours

    the success rate of the puncture

  2. puncture time

    Time frame: through procedure completion, up to 24 hours

    puncture time

  3. complications of the puncture region

    Time frame: the first outpatient visit after discharge

    complications of the puncture region

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2023
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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