Dual Artery Compression vs. Radial Artery-Only Hemostasis: Impact on Radial Artery Occlusion (EASY-RAO)

Study Overview
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Brief Summary
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This study aims to demonstrate the superiority in clinical performances of a dual artery compression device (Terry-2 band) compared to a standard radial artery-only hemostasis device (HemoSTOP).

Official Title
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Randomized Comparison f Dual Artery Compression Versus Radial Artery-Only Hemostasis: Impact on Radial Artery Occlusion (EArly Discharge After Transradial Stenting of coronarY Arteries - EASY-RAO)

Conditions
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Radial Artery Injury

Intervention / Treatment
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* Device: Hemostasis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: any patients referred for diagnostic angiography and possible percutaneous coronary intervention (PCI) Exclusion Criteria: Patient unable to understand study design or objectives Unable to sign informed consent Patient taking warfarin or other anticoagulant therapy Chronic RAO on both sides precluding TRA Previous ipsilateral transradial approach Inability to comply with the study follow-up Presence of plethysmographic waveform with radial and ulnar occlusive compression Pre-existing local complication (i.e. hematoma, pseudo-aneurysm, ...) precluding access-site evaluation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual Artery Compression<br>time to hemostasis and incidence of radial artery occlusion will be monitored while using a dual artery compression device (Terry-2-band) to achieve hemostasis. | Device: Hemostasis<br>* Compression device to achieve hemostasis.<br>|
| Active Comparator: Radial Artery-Only<br>time to hemostasis and incidence of radial artery occlusion will be monitored while using the device currently approved by the institution (Hemo-Stop) and following institutional protocols for hemostasis. | Device: Hemostasis<br>* Compression device to achieve hemostasis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of RAO after transradial approach (TRA) at hospital discharge | To determine whether the use of a dual artery compression decreases the rate of radial artery occlusion after transradial catheterization. | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of radial artery patent-hemostasis during hemostasis | To determine the conservation of blood flow through the radial artery during compressive hemostasis | throughout intervention, up to 180 minutes | 
| Patient comfort during hemostasis as assessed on a visual scale | To evaluate the level of patient comfort in relation to the device used | throughout intervention, up to 30 days | 
| Rates of complications such as repeat bleeding and hematoma (EASY Scale) | To determine the incidence of complications in relation to the device used. Bleeding, spasm and presence of hematomas will be evaluated. | throughout intervention, up to 30 days | 
| Nursing involvement in hemostasis management for sensitivity analysis on cost assessment | To determine the overall nursing involvement (time per nurse per patient) in hemostasis monitoring from end of procedure to patient discharge for a cost-benefit evaluation. | throughout intervention, up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RAO, Hemostasis, TRA