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

November 14, 2016 updated by: Yoon Junghan, Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangwon
      • Wonju, Gangwon, Korea, Republic of, 220-701
        • Wonju Severance Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-oriented composite outcome
Time Frame: 1 year
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
Time Frame: Day 0 (end of procedure)
Conversion rate of access site
Day 0 (end of procedure)
Success of percutaneous coronary intervention
Time Frame: 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
Day 3 (day of discharge)
Procedure time
Time Frame: Day 0 (end of procedure)
Procedure time according to the access site
Day 0 (end of procedure)
Fluoroscopic time
Time Frame: Day 0 (end of procedure)
Fluoroscopic time according to the access site
Day 0 (end of procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Collaborators

The Korean Society of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOTRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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