DISCO RADIAL
Overview
The trial compares the novel distal radial access with conventional radial access approach,
in terms of radial occlusion rates (RAO) at discharge.
DISCO RADIAL is the first large international randomized study designed to investigate the benefits of distal radial access over conventional radial access approach.
Study Design
| Study Type | Randomized Clinical Trial |
|---|---|
| Estimated Enrollment | 1300 participants |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Intervention Model Description | Randomization to distal transradial access or conventional transradial access. Both techniques are standard of care. |
| Masking | None (Open Label) |
| Primary Purpose | Supportive Care |
| Actual Study Start Date | December 10, 2019 |
Primary Endpoint
Primary Outcome Measures
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Forearm radial artery occlusion (RAO) rate before discharge
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[Time Frame: up to 5 days] Forearm radial artery occlusion (RAO) rate before discharge measured with Doppler Ultrasound
Result
Primary endpoint result: RAO at discharge
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Exceptionally low incidence of RAO at discharge in both groups, the lowest ever reported in any multicenter TRA trial. Those results support clinical application of best practice recommendations for the reduction of RAO.
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Patent hemostasis was achieved in 94.4% of patient in the TRA group.
Secondary endpoint result
Key points
DISCO RADIAL is the first large international randomized clinical trial to demonstrate
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support distal radial access as a valid alternative to conventional radial access, with simpler & shorter hemostasis.
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equally low forearm RAO rates with conventional & distal radial access, highlighting the importance and clinical benefits of a rigorous protocol for RAO prevention.
DISCO RADIAL is also the first large international trial implementing best practice recommendations for the reduction of RAO after conventional TRA, including the use of
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Glidesheath Slender™ to apply lower-profile system necessary to complete the procedure.
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TR Band™ to achieve patent hemostasis, with minimal pressure strategy together with short hemostasis time.
Movie
Learn more about DISCO RADIAL from the Primary Investigators
Dr. Adel Aminian, C.H.U. de Charleroi, Belgium
Dr. Shigeru Saito, Shonan Kamakura General Hospital, Japan
