Korea Transradial Coronary Intervention Prospective Registry (KOTRI)

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Transradial coronary angiography and intervention; Procedure: Transfemoral coronary angiography and intervention

• Registration Number: NCT01803841
• Lead Sponsor: Yonsei University

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-03-01
• Study First Posted: 2013-03-04
• Primary Completion: 2015-04
• Study Completion: 2015-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7300

Inclusion Criteria

• All consecutive hospitalized patients undergoing coronary angiography or percutaneous coronary intervention

Read More

Exclusion Criteria

• No exclusion criteria

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transradial access	Transradial coronary angiography and intervention	Coronary angiography and intervention via radial artery approach
Transfemoral access	Transfemoral coronary angiography and intervention	Coronary angiography and intervention via femoral artery approach

Primary Outcome Measures

Name	Time	Method
Patient-oriented composite outcome	1 year	The composite of any death, non-fatal myocardial infarction, and any revascularization

Secondary Outcome Measures

Name	Time	Method
Access failure	Day 0 (end of procedure)	Conversion rate of access site
Success of percutaneous coronary intervention	Day 3 (day of discharge)	Combination of angiographic success and procedural success; 1. Angiographic success; thrombolysis in myocardial infarction (TIMI) flow grad 3 and \<30% residual diameter stenosis; 2. Procedural success; Angiographic success without major procedural or in-hospital complications such as death, Q-wave myocardial infarction, or emergency bypass surgery
Procedure time	Day 0 (end of procedure)	Procedure time according to the access site
Fluoroscopic time	Day 0 (end of procedure)	Fluoroscopic time according to the access site

Trial Locations

Locations (1)

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Gangwon, Korea, Republic of