Safety and Efficacy of Distal Radial Approach

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05776550
Collaborator
(none)
3,600
1
40.4
89

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Registry to Assess the Safety and Efficacy of Distal Radial Approach (SAFE-BOX)
    Actual Study Start Date :
    Jan 5, 2023
    Anticipated Primary Completion Date :
    May 20, 2026
    Anticipated Study Completion Date :
    May 20, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Success rate of examination and procedure [hrough procedure completion, up to 24 hours]

      Success rate of examination and procedure

    Secondary Outcome Measures

    1. the success rate of the puncture [hrough procedure completion, up to 24 hours]

      the success rate of the puncture

    2. puncture time [hrough procedure completion, up to 24 hours]

      puncture time

    3. complications of the puncture region [the first outpatient visit after discharge]

      complications of the puncture region

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yongcheol Kim Yongin Gyeonggi-do Korea, Republic of 16995

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Study Director: Yongcheol Kim, MD, PhD, Severance Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yongcheol Kim, Clinical Associate Professor, Yonsei University
    ClinicalTrials.gov Identifier:
    NCT05776550
    Other Study ID Numbers:
    • 9-2021-0048
    First Posted:
    Mar 20, 2023
    Last Update Posted:
    Mar 20, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 20, 2023