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

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ClinicalTrials.gov Identifier: NCT00851526
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : July 17, 2012
Sponsor:
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center

Study Description
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Brief Summary:

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 or disease
Coronary Bifurcation Lesion

Study Design
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Study Type : Observational
Actual Enrollment : 1919 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Coronary Bifurcation Stenting (COBIS) Registry in South Korea
Study Start Date : January 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008
Groups and Cohorts
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Group/Cohort
Coronary bifurcation lesion


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00851526     History of Changes
Other Study ID Numbers: 2007-04-042
First Posted: February 26, 2009    Key Record Dates
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