Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06835829
NA

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

Sponsor: Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS

View on ClinicalTrials.gov

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

Interventions

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

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