- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00851526
Coronary Bifurcation Stenting (COBIS) Registry in South Korea (COBIS)
July 15, 2012 updated by: Hyeon-Cheol Gwon, Samsung Medical Center
The COBIS registry is multi-center, real-world registry of drug-eluting stenting in coronary bifurcation lesions in South Korea.
The aim of the study was to find out the current status of bifurcation drug-eluting stenting and determine the prognostic factors for long-term outcome in South Korea.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1919
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with coronary bifurcation lesion treated with drug-eluting stents
Description
Inclusion Criteria:
- Age >= 18 years
- Any type of de novo bifurcation lesion with a parent vessel >= 2.5 mm and side branch>= 2.0 mm by visual estimation
- Treated with drug-eluting stent
Exclusion Criteria:
- Cardiogenic Shock
- ST elevation MI within 48hours
- Expected survival less than 1 year
- Left main bifurcation
- Allergy to the antiplatelets
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Coronary bifurcation lesion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of the composite outcome of all-cause death, MI, or any PCI/CABG
Time Frame: 3 years
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3 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of stent thrombosis, and periprocedural MI
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Song PS, Song YB, Yang JH, Hahn JY, Choi SH, Choi JH, Koo BK, Seung KB, Park SJ, Gwon HC. The impact of side branch predilatation on procedural and long-term clinical outcomes in coronary bifurcation lesions treated by the provisional approach. Rev Esp Cardiol (Engl Ed). 2014 Oct;67(10):804-12. doi: 10.1016/j.rec.2014.01.032. Epub 2014 Jul 10.
- Chung S, Her SH, Song PS, Song YB, Hahn JY, Choi JH, Lee SH, Jang Y, Yoon JH, Tahk SJ, Park SJ, Choi SH, Seung KB, Gwon HC. Trans-radial versus trans-femoral intervention for the treatment of coronary bifurcations: results from Coronary Bifurcation Stenting Registry. J Korean Med Sci. 2013 Mar;28(3):388-95. doi: 10.3346/jkms.2013.28.3.388. Epub 2013 Mar 4.
- Song PS, Song YB, Yang JH, Kang GH, Hahn JY, Choi SH, Choi JH, Lee SH, Jang Y, Yoon JH, Tahk SJ, Seung KB, Park SJ, Gwon HC. Periprocedural myocardial infarction is not associated with an increased risk of long-term cardiac mortality after coronary bifurcation stenting. Int J Cardiol. 2013 Aug 20;167(4):1251-6. doi: 10.1016/j.ijcard.2012.03.146. Epub 2012 Apr 9.
- Gwon HC, Hahn JY, Koo BK, Song YB, Choi SH, Choi JH, Lee SH, Jeong MH, Kim HS, Seong IW, Yang JY, Rha SW, Jang Y, Yoon JH, Tahk SJ, Seung KB, Park SJ. Final kissing ballooning and long-term clinical outcomes in coronary bifurcation lesions treated with 1-stent technique: results from the COBIS registry. Heart. 2012 Feb;98(3):225-31. doi: 10.1136/heartjnl-2011-300322. Epub 2011 Sep 20.
- Gwon HC, Choi SH, Song YB, Hahn JY, Jeong MH, Seong IW, Kim HS, Rha SW, Yang JY, Yoon JH, Tahk SJ, Seung KB, Jang Y, Park SJ. Long-term clinical results and predictors of adverse outcomes after drug-eluting stent implantation for bifurcation lesions in a real-world practice: the COBIS (Coronary Bifurcation Stenting) registry. Circ J. 2010 Nov;74(11):2322-8. doi: 10.1253/circj.cj-10-0352. Epub 2010 Sep 28.
- Song YB, Hahn JY, Choi SH, Choi JH, Lee SH, Jeong MH, Kim HS, Seong IW, Yang JY, Rha SW, Jang Y, Yoon JH, Tahk SJ, Seung KB, Park SJ, Gwon HC. Sirolimus- versus paclitaxel-eluting stents for the treatment of coronary bifurcations results: from the COBIS (Coronary Bifurcation Stenting) Registry. J Am Coll Cardiol. 2010 Apr 20;55(16):1743-50. doi: 10.1016/j.jacc.2010.02.008.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
February 25, 2009
First Submitted That Met QC Criteria
February 25, 2009
First Posted (Estimate)
February 26, 2009
Study Record Updates
Last Update Posted (Estimate)
July 17, 2012
Last Update Submitted That Met QC Criteria
July 15, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 2007-04-042
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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