NCT00851526

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,919

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

4.9 years

First QC Date

February 25, 2009

Last Update Submit

July 15, 2012

Conditions

Coronary Bifurcation Lesion

Keywords

Coronary bifurcation lesionDrug-eluting stent

Outcome Measures

Primary Outcomes (1)

  • Incidence of the composite outcome of all-cause death, MI, or any PCI/CABG

    3 years

Secondary Outcomes (1)

  • Incidence of stent thrombosis, and periprocedural MI

    3 years

Study Arms (1)

Coronary bifurcation lesion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with coronary bifurcation lesion treated with drug-eluting stents

You may qualify if:

  • 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

You may not qualify if:

  • Cardiogenic Shock
  • ST elevation MI within 48hours
  • Expected survival less than 1 year
  • Left main bifurcation
  • Allergy to the antiplatelets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (6)

  • 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.

    PMID: 25262126DERIVED

  • 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.

    PMID: 23486858DERIVED

  • 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.

    PMID: 22494861DERIVED

  • 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.

    PMID: 21933939DERIVED

  • 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.

    PMID: 20890049DERIVED

  • 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.

    PMID: 20394879DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Study Start

January 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

KR(1)