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Completed

NCT Number: NCT03068494

Korean Coronary Bifurcation Stenting (COBIS) Registry III

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.

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Key information

Conditions

Coronary Bifurcation Lesion

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Primary outcomes

  1. Target lesion failure

    Time frame: 5 years

    composite of cardiac death, myocardial infarction, or target lesion revascularization

Secondary outcomes

  1. Cardiac death

    Time frame: 5 years

    All deaths were considered cardiac cause unless obvious non-cardiac causes could be identified

  2. Myocardial infarction

    Time frame: 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

  3. Target lesion revascularization

    Time frame: 3 years

    repeat PCI of the lesion within 5 mm of the inserted stent

  4. Stent thrombosis

    Time frame: 5 years

    the Academic Research Consortium as definite, probable, or possible

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: COBIS III

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 1, 2017
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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