Korean Coronary Bifurcation Stenting (COBIS) Registry III

Completed

• Conditions: Coronary Bifurcation Lesion

• Registration Number: NCT03068494
• Lead Sponsor: Samsung Medical Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-02-27
• Study Start: 2017-02-28
• Study First Posted: 2017-03-01
• Primary Completion: 2018-12-29
• Study Completion: 2018-12-29
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2648

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

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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%)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target lesion failure	5 years	composite of cardiac death, myocardial infarction, or target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Cardiac death	5 years	All deaths were considered cardiac cause unless obvious non-cardiac causes could be identified
Myocardial infarction	5 years	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
Target lesion revascularization	3 years	repeat PCI of the lesion within 5 mm of the inserted stent
Stent thrombosis	5 years	the Academic Research Consortium as definite, probable, or possible

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of