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
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: 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 September 18, 2014