Comparison of Left and Right Transradial Approach for CAG and PCI

Study Overview
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Brief Summary
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This trial will compare the procedural success rate between right and left radial approach in patients undergoing coronary angiography and coronary intervention.

Detailed Description
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The three operators who are proficient in the left radial approach for coronary angiography and coronary intervention will be assigned to the right radial approach for 3 months (phase 1). After then, these three operators will switch approach site to the left radial for another 3 months (phase 2). Procedural success, time of the procedure, use of contrast agent, and fluoroscopic data will be compared between right radial approach (phase 1) group and left radial approach (phase 2).

Official Title
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Comparison Between Left and Right Transradial Approach During Coronary Angiography and Percutaneous Coronary Intervention

Conditions
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Coronary Artery Disease, Stable Angina, Unstable Angina, Non-ST Elevation Myocardial Infarction, ST-segment Elevation Myocardial Infarction, Ischemic Heart Disease Without Angina

Intervention / Treatment
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* Procedure: Radial approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects undergoing coronary angiography via radial approach Subjects undergoing coronary intervention via radial approach Subjects give written informed consent Exclusion Criteria: Subjects undergoing procedure(s) other than coronary angiography or intervention Subjects with contraindication of radial approach (i.e, non-palpable radial pulsation, abnormal Allen's test, known radial artery tortuosity or occlusion, arteriovenous fistula for dialysis)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 1 3 months: Right radial approach 4 6 months: Left radial approach
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Right radial approach<br>Right radial approach for coronary angiography and coronary intervention | Procedure: Radial approach<br>* Approach site for coronary angiography and coronary intervention<br>|
| Active Comparator: Left radial approach<br>Left radial approach for coronary angiography and coronary intervention | Procedure: Radial approach<br>* Approach site for coronary angiography and coronary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Finishing coronary angiography/intervention without changing approach site | At the end of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puncture time | Duration from the start of local anesthesia infiltration to the insertion of sheath | At the end of procedure | 
| Coronary angiography time | Duration from the insertion of sheath to the end of coronary angiography | At the end of procedure | 
| Puncture + Coronary angiography time | Sum of puncture time and coronary angiography time | At the end of procedure | 
| Coronary intervention time | Duration from the end of coronary angiography to the end of coronary intervention | At the end of procedure | 
| Contrast amount during coronary angiography | Amount of contrast agent used during coronary angiography | At the end of procedure | 
| Contrast amount during coronary intervention | Amount of contrast agent used during coronary intervention | At the end of procedure | 
| Fluoroscopic dose, dose area product during coronary angiography | Dose area product during coronary angiography | At the end of procedure | 
| Fluoroscopic dose, dose area product during coronary intervention | Dose area product during coronary intervention | At the end of procedure | 
| Fluoroscopic time during coronary angiography | Fluoroscopic time during coronary angiography | At the end of procedure | 
| Fluoroscopic time during coronary intervention | Fluoroscopic time during coronary intervention | At the end of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Access site, Transradial access, Coronary artery disease, Learning curve