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NCT01803841 Clinical Trial

Korea Transradial Coronary Intervention Prospective Registry (KOTRI)

Coronary Artery Disease Clinical Trial

— KOTRI  

Official title:
Korea Transradial Coronary Intervention Prospective Registry (KOTRI)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01803841
Other study ID # KOTRI
Secondary ID
Status Completed
Phase Phase 4
First received February 25, 2013
Last updated November 14, 2016
Start date February 2013
Est. completion date June 2015

Study information
Verified date November 2016
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 7300
Est. completion date June 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- No exclusion criteria

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Transradial coronary angiography and intervention

• Transfemoral coronary angiography and intervention

Locations
Country Name City State
Korea, Republic of Wonju Severance Christian Hospital Wonju Gangwon

Sponsors (2)
Lead Sponsor Collaborator
Yonsei University The Korean Society of Cardiology

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Choe JC, Cha KS, Choi JH, Kim BW, Park JS, Lee HW, Oh JH, Choi JH, Lee HC, Hong TJ, Youn YJ, Lee SH, Cho BR, Kim DI, Han KR, Jeong MH, Yoon J; Korea Transradial Coronary Intervention (KOTRI) Prospective Registry Investigators.. Comparison of Frequency of Bleeding and Major Adverse Cardiac Events After Transradial Versus Transfemoral Intervention in the Recent Antiplatelet Era. Am J Cardiol. 2016 May 15;117(10):1588-95. doi: 10.1016/j.amjcard.2016.02.033. — View Citation

Lee SH, Jeong MH, Han KR, Sim DS, Yoon J, Youn YJ, Cho BR, Cha KS, Hyon MS, Rha SW, Kim BO, Shin WY, Park KS, Cheong SS; Korean Transradial Coronary Intervention Registry Investigators.. Comparison of Transradial and Transfemoral Approaches for Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome and Anemia. Am J Cardiol. 2016 May 15;117(10):1582-7. doi: 10.1016/j.amjcard.2016.02.030. — View Citation

Youn YJ, Lee JW, Ahn SG, Lee SH, Yoon J, Cho BR, Cheong SS, Kim HY, Lee JH, Bae JH, Lee JB, Suh J, Park KS, Han KR, Jeong MH, Rha SW, Her SH, Cho YH, Kim SW. Current Practice of Transradial Coronary Angiography and Intervention: Results from the Korean Tr — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Patient-oriented composite outcome The composite of any death, non-fatal myocardial infarction, and any revascularization 1 year Yes
Secondary Access failure Conversion rate of access site Day 0 (end of procedure) No
Secondary 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) Yes
Secondary Procedure time Procedure time according to the access site Day 0 (end of procedure) No
Secondary Fluoroscopic time Fluoroscopic time according to the access site Day 0 (end of procedure) No
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