Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access
Sponsor: Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS
Summary
Meta-analysis results show that distal radial access (DRA) is associated with a significant reduction in the risk of radial artery occlusion compared to conventional transradial access (TRA). This is of paramount importance in an evolving interventional context where an increasing number of radial access procedures are being performed to address a growing number of independent health conditions. DRA is also associated with a lower rate of vascular access-related adverse events, establishing it as the safest vascular access ever. However, available data show that the success rate of DRA is lower than that of conventional TRA. Also, while the duration of hemostasis has been shown to be shorter, it has most likely not yet reached its full potential for shortening. Thus, the two extreme phases of DRA require important further evaluation. The CompAring uLtrasound-guided Puncture and advanced HemostAsis to cOnventional approaches in distal radial access: a dual randoMizEd praGmatic triAl (ALPHA\&OMEGA) trial will address this lack of knowledge by exploring whether a significantly shorter hemostasis duration can be achieved with DRA when using hemostasis enhancement and exploring whether ultrasound-guided puncture can increase the success rate of DRA.
Official title: Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access: A Dual Randomized Pragmatic Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
480
Start Date
2025-12-31
Completion Date
2026-09-30
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
Transradial potassium ferrate hemostatic patch
Use of a potassium ferrate hemostatic patch to enhance transradial access hemostasis
Distal radial potassium ferrate hemostatic patch
Use of a potassium ferrate hemostatic patch to enhance distal radial access hemostasis
Ultrasound-guidance
Ultrasound guidance for distal radial access
Conventional guidance
Conventional guidance for distal radial access
Locations (6)
Groupe Vivalia, Clinique Saint-Joseph
Arlon, Belgium
CHU Charleroi-Chimay, Marie Curie Hospital
Charleroi, Belgium
CHU Helora, Jolimont Hospital
La Louvière, Belgium
Sant'Eugenio Hospital
Roma, RM, Italy
Sandro Pertini Hospital
Roma, RM, Italy
Mater Salutis Hospital
Legnago, VR, Italy