Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparison of 6F and 7F Sheaths for Coronary Intervention Via Distal Radial Artery Access
Sponsor: China National Center for Cardiovascular Diseases
Summary
This is a multicenter, randomized controlled, prospective, non-inferiority, open-label study aiming to evaluate whether the efficacy and safety of using a 7F thin-walled sheath via distal radial artery (dTRA) access for coronary intervention (PCI) are non-inferior to the use of a 6F thin-walled sheath. The study population includes adult patients who are candidates for coronary intervention. The primary endpoint is the rate of radial artery and distal radial artery occlusion 24 hours post-procedure.
Official title: A Multicenter Study Comparing the Efficacy and Safety of 6F and 7F Thin-Walled Sheaths Via Distal Radial Artery Access for Coronary Intervention
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
574
Start Date
2024-09-10
Completion Date
2026-01-30
Last Updated
2025-02-25
Healthy Volunteers
No
Conditions
Interventions
7F Thin-Walled Sheath
The 7F Thin-Walled Sheath is used during coronary intervention procedures via distal radial artery access. This device has a smaller outer diameter compared to traditional 7F sheaths, designed to reduce the risk of vascular complications while allowing for the performance of complex coronary interventions.
6F Thin-Walled Sheath
The 6F Thin-Walled Sheath is the standard device used in coronary intervention procedures via distal radial artery access. It is employed as a control in this study to compare its efficacy and safety against the 7F Thin-Walled Sheath.
Locations (1)
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, China