Korean Coronary Bifurcation Stenting (COBIS) Registry II

Coronary Bifurcation Lesion Clinical Trial

Official title:

Korean Coronary Bifurcation Stenting (COBIS) Registry II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642992
• Other study ID #: 2010-11-060
• Status: Completed
• Phase: N/A
• First received: July 15, 2012
• Last updated: January 9, 2013
• Start date: January 2011
• Est. completion date: April 2012

Study information

• Verified date: January 2013
• 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 II registry is a multi-center, real-world registry of drug-eluting stenting in coronary bifurcation lesions in South Korea. From 18 major coronary intervention centers in Korea, a total of 2,873 patients were enrolled in this database between January 2003 and December 2009.

The aim of the study was to investigate long-term clinical results and predictors of adverse outcomes after percutaneous coronary intervention with drug-eluting stents for coronary bifurcation lesions in South Korea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2873
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >= 18 years

• Any type of bifurcation lesion in major epicardial artery

• Side branch reference diameter >= 2.3 mm and at least stentable with 2.5 mm stent

• Treated with drug-eluting stent

Exclusion Criteria:

• Protected left main disease previous CABG for LAD or LCX territory

• Cardiogenic Shock

• History of CPR in the same hospitalization

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
Hyeon-Cheol Gwon

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of the composite outcomes of cardiac death, target vessel-related myocardial infarction, or target-lesion revascularization		3 years	Yes
Secondary	Cardiac death		3 years	Yes
Secondary	Myocardial infarction		3 years	Yes
Secondary	Target lesion revascularization		3 years	No
Secondary	Stent thrombosis		3 years	Yes