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

Official title

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

Overview

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.

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

Primary outcome measures

• 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)]
• 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Belgium · 3 centers

• Groupe Vivalia, Clinique Saint-Joseph — Arlon
• CHU Charleroi-Chimay, Marie Curie Hospital — Charleroi
• CHU Helora, Jolimont Hospital — La Louvière

Italy · 3 centers

• Sant'Eugenio Hospital — Roma
• Sandro Pertini Hospital — Roma
• Mater Salutis Hospital — Legnago

Identifiers

NCT: NCT06835829 · 2023-00123

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗