Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access (ALPHA&OMEGA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Catheterization
• Intervention / Treatment: Device: Distal radial potassium ferrate hemostatic patch; Device: Transradial potassium ferrate hemostatic patch; Procedure: Ultrasound-guidance; Procedure: Conventional guidance

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gregory A Sgueglia, MD, PhD; Phone Number: +390651002864; Email: g.a.sgueglia@gmail.com

Study Locations

• Belgium
  • Arlon, Belgium, 6700
    • Recruiting
    • Groupe Vivalia, Clinique Saint-Joseph
    • Contact: Giuseppe Colletti, MD
  • Charleroi, Belgium, 6042
    • Recruiting
    • CHU Charleroi-Chimay, Marie Curie Hospital
    • Contact: Adel Aminian, MD
  • La Louvière, Belgium, 7100
    • Recruiting
    • CHU Helora, Jolimont Hospital
    • Contact: Claudiu Ungureanu, MD
• Italy
  • RM
    • Roma, RM, Italy, 00144
      • Recruiting
      • Sant'Eugenio Hospital
      • Contact: Gregory A. Sgueglia, MD, PhD; Phone Number: +390651002864; Email: g.a.sgueglia@gmail.com
    • Roma, RM, Italy, 00157
      • Recruiting
      • Sandro Pertini Hospital
      • Contact: Alessandro Sciahbasi, MD
  • VR
    • Legnago, VR, Italy, 37045
      • Recruiting
      • Mater Salutis Hospital
      • Contact: Antonio Mugnolo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years.
• Patients presenting with CCS or ACS, including unstable angina or NSTEMI.
• Patients planned for coronary angiography or PCI.
• 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 a history of previous radial artery catheterization.

Exclusion Criteria:

• 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 TRA on both sides.
• Medical conditions that may cause non-compliance with the study protocol and/or may confound the data interpretation.
• Patients unable to provide written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distal radial access	Device: Distal radial potassium ferrate hemostatic patch; Use of a potassium ferrate hemostatic patch to enhance distal radial access hemostasis
Active Comparator: Conventional transradial access	Device: Transradial potassium ferrate hemostatic patch; Use of a potassium ferrate hemostatic patch to enhance transradial access hemostasis
Experimental: Distal radial access ultrasound-guided	Procedure: Ultrasound-guidance; Ultrasound guidance for distal radial access
Active Comparator: Distal radial access conventional guidance	Procedure: Conventional guidance; Conventional guidance for distal radial access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostasis duration.		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.	Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed (on average 1 minute)

Collaborators and Investigators

• Sponsor: Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: February 1, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound guidance; Hemostasis; Distal radial access; Trasnradial access; Potassium ferrate
• Additional Relevant MeSH Terms: Coagulants; Hemostatics
• Other Study ID Numbers: 2023-00123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes