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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Coronary Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Distal radial access

Group Type EXPERIMENTAL

Distal radial potassium ferrate hemostatic patch

Intervention Type DEVICE

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

Conventional transradial access

Group Type ACTIVE_COMPARATOR

Transradial potassium ferrate hemostatic patch

Intervention Type DEVICE

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

Distal radial access ultrasound-guided

Group Type EXPERIMENTAL

Ultrasound-guidance

Intervention Type PROCEDURE

Ultrasound guidance for distal radial access

Distal radial access conventional guidance

Group Type ACTIVE_COMPARATOR

Conventional guidance

Intervention Type PROCEDURE

Conventional guidance for distal radial access

Interventions

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Transradial potassium ferrate hemostatic patch

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

Intervention Type DEVICE

Distal radial potassium ferrate hemostatic patch

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

Intervention Type DEVICE

Ultrasound-guidance

Ultrasound guidance for distal radial access

Intervention Type PROCEDURE

Conventional guidance

Conventional guidance for distal radial access

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No