Postcath Radial Arterial Clamp Time In the CAth Lab

Study Overview
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Brief Summary
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The investigators will assess the effect of different times of radial clamp post procedure on radial artery occlusion and bleeding.

Detailed Description
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The purpose of this study is to determine the safety of shorter radial artery clamp time post cardiac catheterization with respect to achieving hemostasis and the incidence of radial artery occlusion. The investigators hypothesize that shorter radial artery clamp times following cardiac catheterization will achieve similar hemostasis to longer clamp times with a decrease in the incidence of radial artery occlusion.

Official Title
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A Comparison of Radial Artery Clamp Times in Patients Undergoing Cardiac Catheterization Via a Percutaneous Transradial Approach

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Vascular compression device- RADAR TM-Short clamp time
* Device: Vascular compression device RADAR TM-Long clamp time


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who require cardiac catheterization via the radial approach for the investigation and treatment of coronary artery disease. Patients must have evidence of pre-procedural radial artery patency using Barbeau test. Patients must be able to give informed consent Exclusion Criteria: Evidence of pre-procedural radial artery thrombosis Inability to give informed consent Patient desire not to participate in the study Emergent procedures when the delay associated for obtaining informed consent may affect patient outcome
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 |
| --- | --- |
| Experimental: Short Clamp time<br>Radial clamp applied at full pressure for 20 minutes. At the end of 20 minutes, the clamp will be loosened ¼ turn every 5 minutes over 20 minutes and then removed. | Device: Vascular compression device- RADAR TM-Short clamp time<br>* A clamp is placed on the radial artery following cardiac catheterization for 20 minutes<br>|
| Experimental: Long Clamp Time<br>Radial clamp applied at full pressure for 60 minutes. At the end of 60 minutes, the clamp is to be loosened and removed under the same instruction as those patients in arm one. | Device: Vascular compression device RADAR TM-Long clamp time<br>* A clamp is placed on the radial artery following cardiac catheterization for 20 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of radial artery occlusion | Flow assessed by pulse oximeter | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Need to retighten clamp, ooze, hematoma | 24 hours |