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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Distal radial access | Experimental |
| |
| Conventional transradial access | Active Comparator |
| |
| Distal radial access ultrasound-guided | Experimental |
| |
| Distal radial access conventional guidance | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transradial potassium ferrate hemostatic patch | Device | Use of a potassium ferrate hemostatic patch to enhance transradial access hemostasis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregory A Sgueglia, MD, PhD | Contact | +390651002864 | g.a.sgueglia@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Vivalia, Clinique Saint-Joseph | Recruiting | Arlon | 6700 | Belgium |
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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.
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| Distal radial potassium ferrate hemostatic patch | Device | Use of a potassium ferrate hemostatic patch to enhance distal radial access hemostasis |
|
| Ultrasound-guidance | Procedure | Ultrasound guidance for distal radial access |
|
| Conventional guidance | Procedure | Conventional guidance for distal radial access |
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| CHU Charleroi-Chimay, Marie Curie Hospital | Recruiting | Charleroi | 6042 | Belgium |
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| CHU Helora, Jolimont Hospital | Recruiting | La Louvière | 7100 | Belgium |
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| Sant'Eugenio Hospital | Recruiting | Roma | RM | 00144 | Italy |
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| Sandro Pertini Hospital | Recruiting | Roma | RM | 00157 | Italy |
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| Mater Salutis Hospital | Recruiting | Legnago | VR | 37045 | Italy |
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