An interventional study of Transradial potassium ferrate hemostatic patch and Distal radial potassium ferrate hemostatic patch in Coronary Catheterization, sponsored by Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS. Active, not recruiting at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS · Not applicable, Interventional, and Treatment
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.
This is the only study on the registry with Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Distal radial potassium ferrate hemostatic patch
Device: Transradial potassium ferrate hemostatic patch
Procedure: Ultrasound-guidance
Procedure: Conventional guidance
Use of a potassium ferrate hemostatic patch to enhance transradial access hemostasis
Use of a potassium ferrate hemostatic patch to enhance distal radial access hemostasis
Ultrasound guidance for distal radial access
Conventional guidance for distal radial access
Hemostasis duration.
Time frame: From end of procedure to end of hemostasis (25 minutes for distal radial access and 60 minutes for conventional transradial access)
Access success
Access success occurs when an introducer sheath can be properly placed through the punctured artery.
Time frame: Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed (on average 1 minute)
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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