Korean Coronary Bifurcation Stenting (COBIS) Registry III

Coronary Bifurcation Lesion Clinical Trial

— COBIS III  

Official title:

Multicenter, Retrospective Korean Coronary Bifurcation Stenting (COBIS) Registry III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068494
• Other study ID #: 2016-12-136
• Status: Completed
• Start date: February 28, 2017
• Est. completion date: December 29, 2018

Study information

• Verified date: May 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The COBIS III registry is a multi-center, real-world registry of 2nd generation drug-eluting stenting in coronary bifurcation lesions in South Korea. From 21 major coronary intervention centers in Korea, a total of 3,000 patients (anticipated) will be enrolled in this database between January 2010 and December 2014.

The aim of the study was to investigate long-term clinical results and predictors of adverse outcomes after percutaneous coronary intervention with 2nd generation drug-eluting stents for coronary bifurcation lesions in South Korea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2648
• Est. completion date: December 29, 2018
• Est. primary completion date: December 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age >=19 years

• Any type of de novo bifurcation lesion in major epicardial artery: unprotected left main coronary bifurcation lesion, LAD - diagonal, LCX-OM, distal RCA bifurcation. (Excluding RCA-RV branch bifurcation, branch bifurcation)

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

• Treated with drug-eluting stent during the period of 2010. 1 ~ 2014. 12

Exclusion Criteria:

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

• Cardiogenic Shock

• History of CPR in the same hospitalization

• Patients with severe left ventricular systolic dysfunction (ejection fraction < 30%)

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	Target lesion failure	composite of cardiac death, myocardial infarction, or target lesion revascularization	5 years
Secondary	Cardiac death	All deaths were considered cardiac cause unless obvious non-cardiac causes could be identified	5 years
Secondary	Myocardial infarction	an elevation of creatine kinase-myocardial band or troponin level greater than the upper limit of normal with concomitant ischemic symptoms or electrocardiography findings indicative of ischemia	5 years
Secondary	Target lesion revascularization	repeat PCI of the lesion within 5 mm of the inserted stent	3 years
Secondary	Stent thrombosis	the Academic Research Consortium as definite, probable, or possible	5 years