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

NCT06835829 | Recruiting FDA Device

• 1 other identifier: 2023-00123
• Study Type: interventional
• Target: 480
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Coronary Catheterization

Keywords

Trasnradial access; Distal radial access; Ultrasound guidance; Potassium ferrate; Hemostasis

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (4)

Distal radial access

EXPERIMENTAL

Device: Distal radial potassium ferrate hemostatic patch

Conventional transradial access

ACTIVE COMPARATOR

Device: Transradial potassium ferrate hemostatic patch

Distal radial access ultrasound-guided

EXPERIMENTAL

Procedure: Ultrasound-guidance

Distal radial access conventional guidance

ACTIVE COMPARATOR

Procedure: Conventional guidance

Interventions

Transradial potassium ferrate hemostatic patch DEVICE

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

Conventional transradial access

Distal radial potassium ferrate hemostatic patch DEVICE

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

Distal radial access

Ultrasound-guidance PROCEDURE

Ultrasound guidance for distal radial access

Distal radial access ultrasound-guided

Conventional guidance PROCEDURE

Conventional guidance for distal radial access

Distal radial access conventional guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (6)

Groupe Vivalia, Clinique Saint-Joseph

Arlon, 6700, Belgium

RECRUITING

CHU Charleroi-Chimay, Marie Curie Hospital

Charleroi, 6042, Belgium

RECRUITING

CHU Helora, Jolimont Hospital

La Louvière, 7100, Belgium

RECRUITING

Sant'Eugenio Hospital

Roma, RM, 00144, Italy

RECRUITING

Sandro Pertini Hospital

Roma, RM, 00157, Italy

RECRUITING

Mater Salutis Hospital

Legnago, VR, 37045, Italy

RECRUITING

Central Study Contacts

Gregory A Sgueglia, MD, PhD

CONTACT

+390651002864; g.a.sgueglia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective open-label, randomized, controlled trial that integrates two independent nonfactorial randomized comparisons. In the first comparison, 480 patients will be randomized in 1:1 ratio to either to conventional transradial access or distal radial access using the potassium ferrate patch for hemostasis enhancement. In the second comparison, the 240 patients assigned to distal radial access will be randomized 1:1 to either conventional artery puncture or ultrasound-guided puncture.

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 19, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); BE (3)