Coronary Bifurcation Stenting (COBIS) Registry in South Korea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00851526
First received: February 25, 2009
Last updated: July 15, 2012
Last verified: July 2012
  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 Samsung Medical Center:

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

Secondary Outcome Measures:
  • Incidence of stent thrombosis, and periprocedural MI [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851526

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  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: NCT00851526     History of Changes
Other Study ID Numbers: 2007-04-042
Study First Received: February 25, 2009
Last Updated: July 15, 2012
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 April 16, 2014