NCT06835829

Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access

Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access: A Dual Randomized Pragmatic Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Catheterization

Interventions

Type	Name	Description
DEVICE	Transradial potassium ferrate hemostatic patch	Use of a potassium ferrate hemostatic patch to enhance transradial access hemostasis
DEVICE	Distal radial potassium ferrate hemostatic patch	Use of a potassium ferrate hemostatic patch to enhance distal radial access hemostasis
PROCEDURE	Ultrasound-guidance	Ultrasound guidance for distal radial access
PROCEDURE	Conventional guidance	Conventional guidance for distal radial access

Timeline

• Start date: 2025-12-31
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2025-02-19
• Last updated: 2026-03-04

Locations

6 sites across 2 countries: Belgium, Italy

Regulatory

• FDA-regulated device study