Comparison Study of Compression Devices Used in Transradial Coronary Angiography

Study Overview
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Brief Summary
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The transradial route is used in 90% of the coronary angiograms performed at Oslo University Hospital (OUS), Ullevål. A compression device needs to be applied after the procedure to achieve hemostasis. Patients and staff will benefit from using a device that yields safe and painless hemostasis. Patients will be randomly assigned to receive either the standard compression device (control group, A) or a recently developed compression device (experimental group, B). The study will be designed as a non-inferiority, prospective randomized controlled trial, with outcome measures being patient comfort during compression time and complication rates. Complications that will be measured are radial artery occlusion (RAO) measured using ultrasound at a follow up visit. Hematomas or bleeds from the puncture site after application of the compression device will also be classified as complications. The aim of the study is to investigate whether the new device, RY-STOP is non-inferior compared to the standard device, when considering the outcome measures.

Conditions
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Peripheral Artery Occlusion, Hemostasis, Injury of Radial Artery

Intervention / Treatment
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* Device: RY-STOP hemostasis device
* Device: TR-Band, Terumo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing coronary angiograms via the transradial route Exclusion Criteria: Patients who have a long way to travel for the follow up, ultrasound scan Patients that do not understand Norwegian Patients presenting with acute ST segment elevation myocardial infarction (STEMI)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hemostasis achieved by TR Band<br>After the transradial procedure and randomization TR Band will be applied to achieve hemostasis. Patient experience and complications after the application will be measured. | Device: TR-Band, Terumo<br> <br> |
| Experimental: Hemostasis achieved by RY Stop<br>After the transradial procedure and randomization, RY Stop will be applied to achieve hemostasis. Patient experience and complications after the application will be measured. | Device: RY-STOP hemostasis device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial artery occlusion | Subjects wil have an ultrasound scan of their radial artery preformed after their transradial coronary angiogram to see the rate of occluded arteries. | 90-120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient experience | Patients will be asked to rate their comfort level associated with the hemostasis device they have been assigned | 1-4 hours | 
| Device complications | Staff responsible for the application of the hemostasis devices will be asked to observe and record bleeds and hematomas that occur. | 1-4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary angiography, Transradial, Patient experience, VAS, Compression device