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Korea Transradial Coronary Intervention Prospective Registry (KOTRI) (KOTRI)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transradial coronary angiography and intervention
Transfemoral coronary angiography and intervention
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria

Sites / Locations

  • Wonju Severance Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transradial access

Transfemoral access

Arm Description

Coronary angiography and intervention via radial artery approach

Coronary angiography and intervention via femoral artery approach

Outcomes

Primary Outcome Measures

Patient-oriented composite outcome
The composite of any death, non-fatal myocardial infarction, and any revascularization

Secondary Outcome Measures

Access failure
Conversion rate of access site
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
Procedure time
Procedure time according to the access site
Fluoroscopic time
Fluoroscopic time according to the access site

Full Information

First Posted
February 25, 2013
Last Updated
November 14, 2016
Sponsor
Yonsei University
Collaborators
The Korean Society of Cardiology
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1. Study Identification

Unique Protocol Identification Number
NCT01803841
Brief Title
Korea Transradial Coronary Intervention Prospective Registry (KOTRI)
Acronym
KOTRI
Official Title
Korea Transradial Coronary Intervention Prospective Registry (KOTRI)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
Collaborators
The Korean Society of Cardiology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transradial access
Arm Type
Active Comparator
Arm Description
Coronary angiography and intervention via radial artery approach
Arm Title
Transfemoral access
Arm Type
Active Comparator
Arm Description
Coronary angiography and intervention via femoral artery approach
Intervention Type
Procedure
Intervention Name(s)
Transradial coronary angiography and intervention
Intervention Type
Procedure
Intervention Name(s)
Transfemoral coronary angiography and intervention
Primary Outcome Measure Information:
Title
Patient-oriented composite outcome
Description
The composite of any death, non-fatal myocardial infarction, and any revascularization
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Access failure
Description
Conversion rate of access site
Time Frame
Day 0 (end of procedure)
Title
Success of percutaneous coronary intervention
Description
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
Time Frame
Day 3 (day of discharge)
Title
Procedure time
Description
Procedure time according to the access site
Time Frame
Day 0 (end of procedure)
Title
Fluoroscopic time
Description
Fluoroscopic time according to the access site
Time Frame
Day 0 (end of procedure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All consecutive hospitalized patients undergoing coronary angiography or percutaneous coronary intervention Exclusion Criteria: No exclusion criteria
Facility Information:
Facility Name
Wonju Severance Christian Hospital
City
Wonju
State/Province
Gangwon
ZIP/Postal Code
220-701
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27026640
Citation
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):1588-1595. doi: 10.1016/j.amjcard.2016.02.033. Epub 2016 Mar 2.
Results Reference
background
PubMed Identifier
27018932
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):1582-1587. doi: 10.1016/j.amjcard.2016.02.030. Epub 2016 Mar 2.
Results Reference
background
PubMed Identifier
26617647
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 Transradial Intervention Prospective Registry. Korean Circ J. 2015 Nov;45(6):457-68. doi: 10.4070/kcj.2015.45.6.457. Epub 2015 Nov 25.
Results Reference
result
Links:
URL
http://tricrf.medsoft.co.kr
Description
TRI retrospective registry electronic case report form (eCRF)

Learn more about this trial

Korea Transradial Coronary Intervention Prospective Registry (KOTRI)

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