Transradial-Band Pilot Study

Study Overview
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Brief Summary
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In the study group, the TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals. In the standard of care group, the TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals. The aim of the study is to reduce the time the device is in place while minimizing potential complications.

Official Title
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Optimization of Transradial-Band Removal Following Transradial Arterial Access for Interventional Radiology Diagnostic and Interventional Procedures (A Pilot Study)

Conditions
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Radial Artery Incision Site Closure

Intervention / Treatment
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* Device: TR Band 60MIN
* Device: TR Band 120MIN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Have an acceptable Barbeau test (i.e. type A through C) Have acceptable coagulation parameters (based on PT, INR, platelet count, and appropriate pre-procedural management of anticoagulants, See Table 1) The caliber of the left radial artery based on a pre-procedure sonographic evaluation will need to be greater than or equal to 1.6 mm. The appropriate pre-procedural management of anticoagulants is based on the consensus guidelines established by Patel et al16. INR less than 1.5 Platelet count greater than 50,000 platelet/uL Prothrombin time less than 15 seconds Exclusion Criteria: If there is an unacceptable risk of bleeding diathesis, or If he or she is not a suitable candidate for transradial access based on a Barbeau test type D or a diameter of the left radial artery less than 1.6 mm.

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Device: TR Band 60MIN<br>* TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals<br>|
| Active Comparator: Group B<br> | Device: TR Band 120MIN<br>* TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with significant hematomas | Hematoma >5 cm in size | an average of 12 hours post procedure | 
| Percentage of participants with significant hematomas | Hematoma >5 cm in size | 30 days post procedure | 
| Percentage of participants with bleeding | Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma | an average of 12 hours post procedure | 
| Percentage of participants with bleeding | Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma | 30 days post procedure | 
| Left radial artery occlusion | Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test | an average of 12 hours post procedure | 
| Left radial artery occlusion | Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test | 30 days post procedure |