Clinical trial NCT05776550: Safety and Efficacy of Distal Radial Approach (SAFE-BOX)
Official title: A Prospective Registry to Assess the Safety and Efficacy of Distal Radial Approach (SAFE-BOX)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Safety
Efficacy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 3600
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Evaluate the success rate of coronary angiography and intervention in patients with palpable radial artery

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.

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

Primary outcomes:
measure: Success rate of examination and procedure
timeFrame: through procedure completion, up to 24 hours
Secondary outcomes:
measure: the success rate of the puncture
timeFrame: through procedure completion, up to 24 hours
measure: puncture time
timeFrame: through procedure completion, up to 24 hours
measure: complications of the puncture region
timeFrame: the first outpatient visit after discharge
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongcheol Kim
state: Gyeonggi-do
Study officials:
affiliation: Severance Hospital
name: Yongcheol Kim, MD, PhD
role: STUDY_DIRECTOR
References: