Actively Recruiting
Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access
Led by Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS · Updated on 2026-03-04
480
Participants Needed
6
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 218 years.
- Patients presenting with chronic coronary syndrome or acute coronary syndrome, including unstable angina or NSTEMI.
- Patients planned for coronary angiography or percutaneous coronary intervention.
- Patients able to provide written informed consent.
- Patient is willing to comply with all study protocol required evaluations.
- Palpable radial pulse both at conventional and distal puncture site.
- Reverse modified Barbeau test confirming radial artery patency in patients with previous radial artery catheterization.
You will not qualify if you...
- Acute ST-segment elevation myocardial infarction.
- Cardiogenic shock.
- Chronic hemodialysis.
- Contraindications to radial access, such as occlusive upper arm peripheral artery disease or known anatomic variants prohibiting transradial access on both sides.
- Medical conditions that may cause non-compliance with the study protocol or confound data interpretation.
- Patients unable to provide written informed consent.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Groupe Vivalia, Clinique Saint-Joseph
Arlon, Belgium, 6700
Actively Recruiting
2
CHU Charleroi-Chimay, Marie Curie Hospital
Charleroi, Belgium, 6042
Actively Recruiting
3
CHU Helora, Jolimont Hospital
La Louvière, Belgium, 7100
Actively Recruiting
4
Sant'Eugenio Hospital
Roma, RM, Italy, 00144
Actively Recruiting
5
Sandro Pertini Hospital
Roma, RM, Italy, 00157
Actively Recruiting
6
Mater Salutis Hospital
Legnago, VR, Italy, 37045
Actively Recruiting
Research Team
G
Gregory A Sgueglia, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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