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Coronary Bifurcation LesionNCT01642992

Korean Coronary Bifurcation Stenting (COBIS) Registry II

An observational study of Coronary Bifurcation Lesion, run by Hyeon-Cheol Gwon at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The COBIS II registry is a multi-center, real-world registry of drug-eluting stenting in coronary bifurcation lesions in South Korea. From 18 major coronary intervention centers in Korea, a total of 2,873 patients were enrolled in this database between January 2003 and December 2009. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Bifurcation Lesion
How many people
2,873 participants
Where
1 siteSouth Korea
Study dates
Jan 2011to Apr 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with coronary bifurcation lesion treated with drug-eluting stents

Who may be able to join

  • Age >= 18 years
  • Any type of bifurcation lesion in major epicardial artery
  • Side branch reference diameter >= 2.3 mm and at least stentable with 2.5 mm stent
  • Treated with drug-eluting stent

Who cannot join

  • Protected left main disease previous CABG for LAD or LCX territory
  • Cardiogenic Shock
  • History of CPR in the same hospitalization

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

About this study

The COBIS II registry is a multi-center, real-world registry of drug-eluting stenting in coronary bifurcation lesions in South Korea. From 18 major coronary intervention centers in Korea, a total of 2,873 patients were enrolled in this database between January 2003 and December 2009.

The aim of the study was to investigate long-term clinical results and predictors of adverse outcomes after percutaneous coronary intervention with drug-eluting stents for coronary bifurcation lesions in South Korea.

Keywords
Coronary bifurcation lesion, Drug-eluting stent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01642992
Study groupRoleWhat they receive
Coronary bifurcation lesionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of the composite outcomes of cardiac death, target vessel-related myocardial infarction, or target-lesion revascularization

    Measured: 3 years

Secondary outcomes (4)

  1. Cardiac death

    Measured: 3 years

  2. Myocardial infarction

    Measured: 3 years

  3. Target lesion revascularization

    Measured: 3 years

  4. Stent thrombosis

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2012 (estimated)
  2. Study startJan 2011
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
2,873 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01642992
Sponsor's protocol ID
2010-11-060
Status last verified
Jan 2013
First submitted
15 Jul 2012
Last updated
10 Jan 2013
Results posted
No

Publications

  • Choi KH, Bruno F, Cho YK, De Luca L, Song YB, Kang J, Mattesini A, Gwon HC, Truffa A, Kim HS, Wanha W, Chun WJ, Gili S, Hur SH, Helft G, Han SH, Cortese B, Lee CH, Escaned J, Yoon HJ, Chieffo A, Hahn JY, Gallone G, Choi SH, De Ferrari G, Koo BK, Quadri G, D'Ascenzo F, Nam CW, de Filippo O. Comparison of Outcomes Between 1- and 2-Stent Techniques for Medina Classification 0.0.1 Coronary Bifurcation Lesions. JACC Cardiovasc Interv. 2023 Sep 11;16(17):2083-2093. doi: 10.1016/j.jcin.2023.06.013. Epub 2023 Aug 9.

    PubMed 37565964

  • Lee JM, Lee SH, Kim J, Choi KH, Park TK, Yang JH, Song YB, Hahn JY, Choi JH, Choi SH, Kim HS, Chun WJ, Nam CW, Hur SH, Han SH, Rha SW, Chae IH, Jeong JO, Heo JH, Yoon J, Lim DS, Park JS, Hong MK, Doh JH, Cha KS, Kim DI, Lee SY, Chang K, Hwang BH, Choi SY, Jeong MH, Hong SJ, Koo BK, Gwon HC. Ten-Year Trends in Coronary Bifurcation Percutaneous Coronary Intervention: Prognostic Effects of Patient and Lesion Characteristics, Devices, and Techniques. J Am Heart Assoc. 2021 Sep 21;10(18):e021632. doi: 10.1161/JAHA.121.021632. Epub 2021 Sep 13.

    PubMed 34514841

  • Yang JH, Lee JM, Park TK, Song YB, Hahn JY, Choi JH, Choi SH, Yu CW, Chun WJ, Oh JH, Koo BK, Jeong JO, Kim HS, Gwon HC. The Proximal Optimization Technique Improves Clinical Outcomes When Treated without Kissing Ballooning in Patients with a Bifurcation Lesion. Korean Circ J. 2019 Jun;49(6):485-494. doi: 10.4070/kcj.2018.0352. Epub 2019 Feb 22.

    PubMed 30891962

  • Jang WJ, Ahn SG, Song YB, Choi SH, Chun WJ, Oh JH, Cho SW, Kim BS, Yoon JH, Koo BK, Yu CW, Jang YS, Tahk SJ, Kim HS, Gwon HC, Lee SY, Hahn JY. Benefit of Prolonged Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stent for Coronary Bifurcation Lesions: Results From the Coronary Bifurcation Stenting Registry II. Circ Cardiovasc Interv. 2018 Jul;11(7):e005849. doi: 10.1161/CIRCINTERVENTIONS.117.005849.

    PubMed 30006330

  • Yu CW, Yang JH, Song YB, Hahn JY, Choi SH, Choi JH, Lee HJ, Oh JH, Koo BK, Rha SW, Jeong JO, Jeong MH, Yoon JH, Jang Y, Tahk SJ, Kim HS, Gwon HC. Long-Term Clinical Outcomes of Final Kissing Ballooning in Coronary Bifurcation Lesions Treated With the 1-Stent Technique: Results From the COBIS II Registry (Korean Coronary Bifurcation Stenting Registry). JACC Cardiovasc Interv. 2015 Aug 24;8(10):1297-1307. doi: 10.1016/j.jcin.2015.04.015.

    PubMed 26315732

  • Song YB, Hahn JY, Yang JH, Choi SH, Choi JH, Lee SH, Jeong MH, Kim HS, Lee JH, Yu CW, Rha SW, Jang Y, Yoon JH, Tahk SJ, Seung KB, Oh JH, Park JS, Gwon HC. Differential prognostic impact of treatment strategy among patients with left main versus non-left main bifurcation lesions undergoing percutaneous coronary intervention: results from the COBIS (Coronary Bifurcation Stenting) Registry II. JACC Cardiovasc Interv. 2014 Mar;7(3):255-63. doi: 10.1016/j.jcin.2013.11.009. Epub 2014 Feb 13.

    PubMed 24529936

  • Hahn JY, Chun WJ, Kim JH, Song YB, Oh JH, Koo BK, Rha SW, Yu CW, Park JS, Jeong JO, Choi SH, Choi JH, Jeong MH, Yoon JH, Jang Y, Tahk SJ, Kim HS, Gwon HC. Predictors and outcomes of side branch occlusion after main vessel stenting in coronary bifurcation lesions: results from the COBIS II Registry (COronary BIfurcation Stenting). J Am Coll Cardiol. 2013 Oct 29;62(18):1654-1659. doi: 10.1016/j.jacc.2013.07.041. Epub 2013 Aug 14.

    PubMed 23954335

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Bifurcation Lesion, run by Hyeon-Cheol Gwon at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of the composite outcomes of cardiac death, target vessel-related myocardial infarction, or target-lesion revascularization (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01642992, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.

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