Korean Coronary Bifurcation Stenting (COBIS) Registry II

January 9, 2013 updated by: Hyeon-Cheol Gwon

The COBIS II registry is a multi-center, real-world registry of drug-eluting stenting in coronary bifurcation lesions in South Korea. From 18 major coronary intervention centers in Korea, a total of 2,873 patients were enrolled in this database between January 2003 and December 2009.

The aim of the study was to investigate long-term clinical results and predictors of adverse outcomes after percutaneous coronary intervention with drug-eluting stents for coronary bifurcation lesions in South Korea.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2873

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with coronary bifurcation lesion treated with drug-eluting stents

Description

Inclusion Criteria:

  • Age >= 18 years
  • Any type of bifurcation lesion in major epicardial artery
  • Side branch reference diameter >= 2.3 mm and at least stentable with 2.5 mm stent
  • Treated with drug-eluting stent

Exclusion Criteria:

  • Protected left main disease previous CABG for LAD or LCX territory
  • Cardiogenic Shock
  • History of CPR in the same hospitalization

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

Cohorts and Interventions

Group / Cohort
Coronary bifurcation lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of the composite outcomes of cardiac death, target vessel-related myocardial infarction, or target-lesion revascularization
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Stent thrombosis
Time Frame: 3 years
3 years
Myocardial infarction
Time Frame: 3 years
3 years
Cardiac death
Time Frame: 3 years
3 years
Target lesion revascularization
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Hyeon-Cheol Gwon

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

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

January 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 15, 2012

First Submitted That Met QC Criteria

July 15, 2012

First Posted (Estimate)

July 17, 2012

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 9, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010-11-060

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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