Left Versus Right Transradial Approach for Percutaneous Coronary Procedures

Study Overview
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Brief Summary
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Transradial approach of cardiac catheterization is a common alternative to transfemoral access for diagnostic coronary angiography and percutaneous coronary interventions (PCI). The transradial approach reduces access site bleeding complications and the procedural discomfort of the patients. Transradial procedures may be performed by cannulation of the right or left radial artery and at present, the choice of the right or left radial artery depends largely on the operator' s preference. The aim of this study is to evaluate safety and efficacy of transradial approach comparing the right radial versus the left radial approach in coronary diagnostic and interventional procedures. The investigators will enroll consecutively for 12 months all patients who undergo to diagnostic or interventional procedures through trans radial approach in two Italian centers (Casilino Policlinic, Catholic University-Rome). Primary end point of the study is the fluoroscopy time and the radiation dose adsorbed by the patients. Secondary end-points are: contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications. The investigators pre-specified a sub-study in patients older than 75 years old with the same end-points.

Official Title
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Transradial Approach [LEft vs Right] aNd Procedural Times During Percutaneous Coronary Procedures: TALENT Study

Conditions
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Coronary Angiography, Angioplasty, Transluminal, Percutaneous Coronary

Intervention / Treatment
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* Procedure: Right radial
* Procedure: left radial


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who undergo to diagnostic or interventional procedures Exclusion Criteria: Previous coronary artery by-pass Acute myocardial infarction with ST segment elevation myocardial infarction Cardiogenic shock Ischemic Allen Test

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right transradial approach<br>Coronary diagnostic or interventional procedures performed through right radial approach | Procedure: Right radial<br>* diagnostic or interventional procedures performed through right transradial approach<br>|
| Experimental: Left transradial approach<br>Diagnostic or interventional procedures performed through left radial approach | Procedure: left radial<br>* diagnostic or interventional procedures performed through left transradial approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary end point of the study is the fluoroscopy time of the procedure and the radiation dose adsorbed by the patients |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications. |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary angiography, percutaneous coronary intervention, Transradial approach