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NCT Number: NCT06835829

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

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.

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Key information

Conditions

Coronary Catheterization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Vivalia, Clinique Saint-Joseph, Arlon, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transradial potassium ferrate hemostatic patch

Device

Use of a potassium ferrate hemostatic patch to enhance transradial access hemostasis

Distal radial potassium ferrate hemostatic patch

Device

Use of a potassium ferrate hemostatic patch to enhance distal radial access hemostasis

Ultrasound-guidance

Procedure

Ultrasound guidance for distal radial access

Conventional guidance

Procedure

Conventional guidance for distal radial access

Primary outcomes

  1. 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)

  2. Access success

    Time frame: Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed (on average 1 minute)

    Access success occurs when an introducer sheath can be properly placed through the punctured artery.

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory A Sgueglia, MD, PhD

CONTACT

[email protected]

+390651002864

Sponsors and collaborators

Lead sponsor

Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS

Other

Registry information

Official study title

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

Acronym: ALPHA&OMEGA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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