Korea Transradial Coronary Intervention Prospective Registry (KOTRI)

Study Overview
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Brief Summary
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The aim of this registry is to analyze several factors affecting the procedural success and clinical outcomes at 1 year of follow-up according to the approach site.

Detailed Description
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This registry is a multi-center prospective registry for patients undergoing coronary angiography or percutaneous coronary intervention either transradial or transfemoral approach from 22 centers in South Korea. The aim of this registry is to analyze several factors affecting the procedural success and clinical outcomes at 1 year of follow-up according to the approach site.

Official Title
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Korea Transradial Coronary Intervention Prospective Registry (KOTRI)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Transradial coronary angiography and intervention
* Procedure: Transfemoral coronary angiography and intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consecutive hospitalized patients undergoing coronary angiography or percutaneous coronary intervention Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
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Minimum Age: 19 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transradial access<br>Coronary angiography and intervention via radial artery approach | Procedure: Transradial coronary angiography and intervention<br> <br> |
| Active Comparator: Transfemoral access<br>Coronary angiography and intervention via femoral artery approach | Procedure: Transfemoral coronary angiography and intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-oriented composite outcome | The composite of any death, non-fatal myocardial infarction, and any revascularization | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access failure | Conversion rate of access site | Day 0 (end of procedure) | 
| Success of percutaneous coronary intervention | Combination of angiographic success and procedural success Angiographic success; thrombolysis in myocardial infarction (TIMI) flow grad 3 and <30% residual diameter stenosis Procedural success; Angiographic success without major procedural or in-hospital complications such as death, Q-wave myocardial infarction, or emergency bypass surgery | Day 3 (day of discharge) | 
| Procedure time | Procedure time according to the access site | Day 0 (end of procedure) | 
| Fluoroscopic time | Fluoroscopic time according to the access site | Day 0 (end of procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease