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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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 November 19, 2014