Assessing the safety and effectiveness of a new approach to coronary procedures
A Prospective Registry to Assess the Safety and Efficacy of Distal Radial Approach (SAFE-BOX)
This study is testing a new way to perform heart procedures through the wrist to see if it makes patients feel more comfortable and recover faster compared to the usual method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3600 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Yongin, Gyeonggi-do) |
| Trial ID | NCT05776550 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and efficacy of the distal radial approach for coronary artery procedures. It focuses on the advantages of this technique, such as reduced bleeding and increased patient comfort, allowing for immediate mobility post-procedure. The study will involve a prospective registry of patients over 20 years old who require coronary angiography or intervention and have a palpable distal radial artery. The research will compare outcomes with traditional radial artery approaches to determine the benefits of this newer method.
Who should consider this trial
Good fit: Ideal candidates are patients over 20 years old requiring coronary angiography or intervention with a palpable distal radial artery.
Not a fit: Patients with a non-palpable or too small distal radial artery, pregnant women, or those deemed inappropriate by the researcher may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient comfort and safety during coronary procedures.
How similar studies have performed: While the distal radial approach is gaining attention, this specific study is among the early efforts to systematically assess its safety and efficacy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Yongin, Gyeonggi-do
- Yongcheol Kim — Yongin, Gyeonggi-do, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Yongcheol Kim, MD, PhD
- Email: yongcheol@yuhs.ac
- Phone: +823151898967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.