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Korean Coronary Bifurcation Stenting (COBIS) Registry II

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01642992
First received: July 15, 2012
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Coronary Bifurcation Lesion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Korean Coronary Bifurcation Stenting (COBIS) Registry II

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Incidence of the composite outcomes of cardiac death, target vessel-related myocardial infarction, or target-lesion revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cardiac death [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 2873
Study Start Date: January 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Coronary bifurcation lesion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with coronary bifurcation lesion treated with drug-eluting stents

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642992

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Hyeon-Cheol Gwon
  More Information

No publications provided

Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01642992     History of Changes
Other Study ID Numbers: 2010-11-060
Study First Received: July 15, 2012
Last Updated: January 9, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
Coronary bifurcation lesion
Drug-eluting stent

ClinicalTrials.gov processed this record on May 16, 2013