Korean Coronary Bifurcation Stenting (COBIS) Registry III (COBIS III)

May 6, 2019 updated by: Hyeon-Cheol Gwon, Samsung Medical Center

Multicenter, Retrospective Korean Coronary Bifurcation Stenting (COBIS) Registry III

The COBIS III registry is a multi-center, real-world registry of 2nd generation drug-eluting stenting in coronary bifurcation lesions in South Korea. From 21 major coronary intervention centers in Korea, a total of 3,000 patients (anticipated) will be enrolled in this database between January 2010 and December 2014.

The aim of the study was to investigate long-term clinical results and predictors of adverse outcomes after percutaneous coronary intervention with 2nd generation drug-eluting stents for coronary bifurcation lesions in South Korea.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2648

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary bifurcation lesion treated with 2nd generation drug-eluting stents

Description

Inclusion Criteria:

  • Age >=19 years
  • Any type of de novo bifurcation lesion in major epicardial artery: unprotected left main coronary bifurcation lesion, LAD - diagonal, LCX-OM, distal RCA bifurcation. (Excluding RCA-RV branch bifurcation, branch bifurcation)
  • Side branch or LCX reference diameter >= 2.3 mm and at least stentable with 2.5 mm stent
  • Treated with drug-eluting stent during the period of 2010. 1 ~ 2014. 12

Exclusion Criteria:

  • Protected left main disease previous CABG for LAD or LCX territory
  • Cardiogenic Shock
  • History of CPR in the same hospitalization
  • Patients with severe left ventricular systolic dysfunction (ejection fraction < 30%)

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
Measure Description
Time Frame
Target lesion failure
Time Frame: 5 years
composite of cardiac death, myocardial infarction, or target lesion revascularization
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death
Time Frame: 5 years
All deaths were considered cardiac cause unless obvious non-cardiac causes could be identified
5 years
Myocardial infarction
Time Frame: 5 years
an elevation of creatine kinase-myocardial band or troponin level greater than the upper limit of normal with concomitant ischemic symptoms or electrocardiography findings indicative of ischemia
5 years
Target lesion revascularization
Time Frame: 3 years
repeat PCI of the lesion within 5 mm of the inserted stent
3 years
Stent thrombosis
Time Frame: 5 years
the Academic Research Consortium as definite, probable, or possible
5 years

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Hyeon-Cheol Gwon, Professor, Samsung Medical Center

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 (Actual)

February 28, 2017

Primary Completion (Actual)

December 29, 2018

Study Completion (Actual)

December 29, 2018

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (Actual)

March 1, 2017

Study Record Updates

Last Update Posted (Actual)

May 8, 2019

Last Update Submitted That Met QC Criteria

May 6, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016-12-136

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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