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Korean Coronary Bifurcation Stenting (COBIS) Registry III (COBIS III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03068494
Recruitment Status : Completed
First Posted : March 1, 2017
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, 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.


Condition or disease
Coronary Bifurcation Lesion

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2648 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 5 Years
Official Title: Multicenter, Retrospective Korean Coronary Bifurcation Stenting (COBIS) Registry III
Actual Study Start Date : February 28, 2017
Actual Primary Completion Date : December 29, 2018
Actual Study Completion Date : December 29, 2018

Group/Cohort
Coronary Bifurcation Lesion



Primary Outcome Measures :
  1. Target lesion failure [ Time Frame: 5 years ]
    composite of cardiac death, myocardial infarction, or target lesion revascularization


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary bifurcation lesion treated with 2nd generation drug-eluting stents
Criteria

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%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068494


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Hyeon-Cheol Gwon, Professor Samsung Medical Center

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03068494    
Other Study ID Numbers: 2016-12-136
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hyeon-Cheol Gwon, Samsung Medical Center:
Coronary Bifurcation Lesion
2nd generation drug-eluting stent