Clinical trial NCT06835829: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Catheterization
Keywords: Trasnradial access
Distal radial access
Ultrasound guidance
Potassium ferrate
Hemostasis
Lead sponsor: Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Hemostasis duration.
timeFrame: From end of procedure to end of hemostasis (25 minutes for distal radial access and 60 minutes for conventional transradial access)
measure: Access success
timeFrame: Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed (on average 1 minute)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: