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Coronary Bifurcation Stenting (COBIS) Registry in South Korea (COBIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00851526
First Posted: February 26, 2009
Last Update Posted: July 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center
  Purpose

The COBIS registry is multi-center, real-world registry of drug-eluting stenting in coronary bifurcation lesions in South Korea.

The aim of the study was to find out the current status of bifurcation drug-eluting stenting and determine the prognostic factors for long-term outcome in South Korea.


Condition
Coronary Bifurcation Lesion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Coronary Bifurcation Stenting (COBIS) Registry in South Korea

Further study details as provided by Hyeon-Cheol Gwon, Samsung Medical Center:

Primary Outcome Measures:
  • Incidence of the composite outcome of all-cause death, MI, or any PCI/CABG [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Incidence of stent thrombosis, and periprocedural MI [ Time Frame: 3 years ]

Enrollment: 1919
Study Start Date: January 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Coronary bifurcation lesion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 de novo bifurcation lesion with a parent vessel >= 2.5 mm and side branch>= 2.0 mm by visual estimation
  • Treated with drug-eluting stent

Exclusion Criteria:

  • Cardiogenic Shock
  • ST elevation MI within 48hours
  • Expected survival less than 1 year
  • Left main bifurcation
  • Allergy to the antiplatelets
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851526


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00851526     History of Changes
Other Study ID Numbers: 2007-04-042
First Submitted: February 25, 2009
First Posted: February 26, 2009
Last Update Posted: July 17, 2012
Last Verified: July 2012

Keywords provided by Hyeon-Cheol Gwon, Samsung Medical Center:
Coronary bifurcation lesion
Drug-eluting stent