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

Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS

Status: Not yet enrolling

Conditions: Coronary Catheterization

Treatments: Procedure: Ultrasound-guidance; Device: Distal radial potassium ferrate hemostatic patch; Device: Transradial potassium ferrate hemostatic patch; Procedure: Conventional guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT06835829

2023-00123

Details and patient eligibility

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 4 patient groups

Distal radial access

Experimental group

Treatment:

Device: Distal radial potassium ferrate hemostatic patch

Conventional transradial access

Active Comparator group

Treatment:

Device: Transradial potassium ferrate hemostatic patch

Distal radial access ultrasound-guided

Experimental group

Treatment:

Procedure: Ultrasound-guidance

Distal radial access conventional guidance

Active Comparator group

Treatment:

Procedure: Conventional guidance