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

NCT06835829 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2026-03-04

No results posted yet for this study

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

Interventions

DEVICE

Transradial potassium ferrate hemostatic patch

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

DEVICE

Distal radial potassium ferrate hemostatic patch

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

PROCEDURE

Ultrasound-guidance

Ultrasound guidance for distal radial access

PROCEDURE

Conventional guidance

Conventional guidance for distal radial access

Sponsors & Collaborators

  • Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-06-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • Belgium
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06835829 on ClinicalTrials.gov