Coronary Bifurcation Stenting (COBIS) Registry in South Korea

Coronary Bifurcation Lesion Clinical Trial

— COBIS  

Official title:

Coronary Bifurcation Stenting (COBIS) Registry in South Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851526
• Other study ID #: 2007-04-042
• Status: Completed
• Phase: N/A
• First received: February 25, 2009
• Last updated: July 15, 2012
• Start date: January 2004
• Est. completion date: December 2008

Study information

• Verified date: July 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1919
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Bifurcation Lesion

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of the composite outcome of all-cause death, MI, or any PCI/CABG		3 years	Yes
Secondary	Incidence of stent thrombosis, and periprocedural MI		3 years	Yes