Radial Artery Puncture Hemostasis Study

Study Overview
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Brief Summary
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RAPHE is an open label randomized clinical trial to assess physical, biological and chemical methods of radial artery puncture hemostasis following coronary catheterization. A total of 600 subjects will be randomized in a 1:1:1 fashion to either the StatSeal, Axiostat or TR Band hemostasis devices. Follow-up of the subject will take place 60 days after the index procedure.

Official Title
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Radial Artery Puncture Hemostasis: Physical, Biological and Chemical Methods

Conditions
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Radial Artery Hemostasis

Intervention / Treatment
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* Device: Radial artery hemostasis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary angiogram planned from a radial artery approach Use of 5, 6 or 7 French sheaths Exclusion Criteria: Radial artery diameter <1.8 mm as measured via ultrasound Established peripheral arterial disease Known autoimmune illness Hemodynamic instability Pregnant or nursing Condition following resuscitation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Terumo TR Band<br>Physical standard of care radial hemostasis device. | Device: Radial artery hemostasis<br>* Each of the devices will be assessed for radial artery hemostasis.<br>|
| Experimental: StatSeal<br>Potassium-ferrate based chemical hemostasis device. | Device: Radial artery hemostasis<br>* Each of the devices will be assessed for radial artery hemostasis.<br>|
| Experimental: Axiostat<br>Chitosan based biological hemostasis device. | Device: Radial artery hemostasis<br>* Each of the devices will be assessed for radial artery hemostasis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial artery occlusion | Frequency of radial artery occlusion after hemostasis | 24 hours post-procedure or at hospital discharge (whichever comes first) | 
| Radial artery occlusion | Frequency of radial artery occlusion after hemostasis | 60 days (+/-10 days) post-procedure | 
| Radial artery (pseudo)aneurysm formation | Frequency of radial artery (pseudo)aneurysm formation after hemostasis | 24 hours post-procedure or at hospital discharge (whichever comes first) | 
| Radial artery (pseudo)aneurysm formation | Frequency of radial artery (pseudo)aneurysm formation after hemostasis | 60 days (+/-10 days) post-procedure | 
| Radial artery fistula formation | Frequency of radial artery arteriovenous fistula formation after hemostasis | 24 hours post-procedure or at hospital discharge (whichever comes first) | 
| Radial artery fistula formation | Frequency of radial artery arteriovenous fistula formation after hemostasis | 60 days (+/-10 days) post-procedure | 
| Radial artery bleeding | Bleeding from the radial artery puncture, classified via the EASY method | 24 hours post-procedure or at hospital discharge (whichever comes first) | 
| Radial artery bleeding | Bleeding from the radial artery puncture, classified via the EASY method | 60 days (+/-10 days) post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial compression time of hemostatsis device | Initial time (in minutes) of the hemostasis device, needed to achieve primary patent hemostasis | Up to 30 minutes post-procedure | 
| Overall compression time | Overall time (in minutes) of device use as a hemostatis tool | Up to 24 hours post-procedure | 
| Number of compression devices needed | Overall number of compression devices needed for hemostatis | Up to 24 hours post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radial artery puncture, Radial artery occlusion, Radial artery bleeding