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Coronary Bifurcation LesionCOBIS IIINCT03068494

Korean Coronary Bifurcation Stenting (COBIS) Registry III

An observational study of Coronary Bifurcation Lesion, run by Samsung Medical Center 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 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Coronary Bifurcation Lesion
How many people
2,648 participants
Where
1 siteSouth Korea
Study dates
28 Feb 2017to 29 Dec 2018
How long will I take part?
5 Years
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with coronary bifurcation lesion treated with 2nd generation drug-eluting stents

Who may be able to join

  • 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

Who cannot join

  • 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%)

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

Official title: Multicenter, Retrospective 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.

Keywords
Coronary Bifurcation Lesion, 2nd generation 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 NCT03068494
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. Target lesion failure

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

    Measured: 5 years

Secondary outcomes (4)

  1. Cardiac death

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

    Measured: 5 years

  2. Myocardial infarction

    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

    Measured: 5 years

  3. Target lesion revascularization

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

    Measured: 3 years

  4. Stent thrombosis

    the Academic Research Consortium as definite, probable, or possible

    Measured: 5 years

Timeline

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

  1. First posted1 Mar 2017
  2. Study start28 Feb 2017
  3. Primary completion29 Dec 2018
  4. Study completion29 Dec 2018

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
Cross-sectional
Enrolment
2,648 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03068494
Sponsor's protocol ID
2016-12-136
Acronym
COBIS III
Status last verified
May 2019
First submitted
27 Feb 2017
Last updated
8 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Choi KH, Nam CW, Bruno F, Cho YK, De Luca L, Kang J, Mattesini A, Song YB, Truffa A, Kim HS, Wanha W, Chun WJ, Gili S, 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, Hur SH, D'Ascenzo F, Gwon HC, de Filippo O. Differential Prognosis of True Bifurcation Lesions According to Left Main Versus Non-Left Main Location and Treatment Strategy. J Am Heart Assoc. 2025 Feb 4;14(3):e037657. doi: 10.1161/JAHA.124.037657. Epub 2025 Feb 3.

    PubMed 39895551

  • Ahn HJ, Bruno F, Kang J, Hwang D, Yang HM, Han JK, De Luca L, de Filippo O, Mattesini A, Park KW, Truffa A, Wanha W, Song YB, Gili S, Chun WJ, Helft G, Hur SH, Cortese B, Han SH, Escaned J, Chieffo A, Choi KH, Gallone G, Doh JH, De Ferrari G, Hong SJ, Quadri G, Nam CW, Gwon HC, Kim HS, D'Ascenzo F, Koo BK. Sex Differences in Procedural Characteristics and Clinical Outcomes Among Patients Undergoing Bifurcation PCI. Korean Circ J. 2025 Jan;55(1):5-16. doi: 10.4070/kcj.2024.0172. Epub 2024 Oct 11.

    PubMed 39601395

  • Lee JH, Youn YJ, Jeon HS, Lee JW, Ahn SG, Yoon J, Gwon HC, Song YB, Choi KH, Kim HS, Chun WJ, Hur SH, Nam CW, Cho YK, Han SH, Rha SW, Chae IH, Jeong JO, Heo JH, Lim DS, Park JS, Hong MK, Doh JH, Cha KS, Kim DI, Lee SY, Chang K, Hwang BH, Choi SY, Jeong MH, Lee HJ. Transradial Versus Transfemoral Access for Bifurcation Percutaneous Coronary Intervention Using Second-Generation Drug-Eluting Stent. J Korean Med Sci. 2024 Mar 18;39(10):e111. doi: 10.3346/jkms.2024.39.e111.

    PubMed 38501187

  • 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

  • Cha JJ, Hong SJ, Kim JH, Lim S, Joo HJ, Park JH, Yu CW, Kang J, Kim HS, Gwon HC, Chun WJ, Hur SH, Han SH, Rha SW, Chae IH, Jeong JO, Heo JH, Yoon J, Park JS, Hong MK, Doh JH, Cha KS, Kim DI, Lee SY, Chang K, Hwang BH, Choi SY, Jeong MH, Song YB, Choi KH, Nam CW, Koo BK, Lim DS. Bifurcation strategies using second-generation drug-eluting stents on clinical outcomes in diabetic patients. Front Cardiovasc Med. 2022 Dec 21;9:1018802. doi: 10.3389/fcvm.2022.1018802. eCollection 2022.

    PubMed 36620646

  • Lee CH, Nam CW, Cho YK, Yoon HJ, Kim KB, Gwon HC, Kim HS, Chun WJ, Han SH, Rha SW, Chae IH, Jeong JO, Heo JH, Yoon J, Lim DS, Park JS, Hong MK, Lee SY, Cha KS, Kim DI, Bae JW, Chang K, Hwang BH, Choi SY, Jeong MH, Choi KH, Song YB, Hong SJ, Doh JH, Koo BK, Hur SH. 5-Year Outcome of Simple Crossover Stenting in Coronary Bifurcation Lesions Compared With Side Branch Opening. JACC Asia. 2021 Jun 15;1(1):53-64. doi: 10.1016/j.jacasi.2021.04.002. eCollection 2021 Jun.

    PubMed 36338374

  • Choi KH, Song YB, Lee JM, Park TK, Yang JH, Hahn JY, Choi JH, Choi SH, Kim HS, Chun WJ, 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, Nam CW, Koo BK, Gwon HC. Differential Long-Term Effects of First- and Second-Generation DES in Patients With Bifurcation Lesions Undergoing PCI. JACC Asia. 2021 Jun 15;1(1):68-79. doi: 10.1016/j.jacasi.2021.04.006. eCollection 2021 Jun.

    PubMed 36338362

  • 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

  • Choi KH, Song YB, Lee JM, Park TK, Yang JH, Hahn JY, Choi JH, Choi SH, Kim HS, Chun WJ, 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, Nam CW, Koo BK, Gwon HC. Prognostic Effects of Treatment Strategies for Left Main Versus Non-Left Main Bifurcation Percutaneous Coronary Intervention With Current-Generation Drug-Eluting Stent. Circ Cardiovasc Interv. 2020 Feb;13(2):e008543. doi: 10.1161/CIRCINTERVENTIONS.119.008543. Epub 2020 Feb 7.

    PubMed 32069106

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Bifurcation Lesion, run by Samsung Medical Center 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 4 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 8 May 2019. 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?

Target lesion failure (time frame: 5 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 NCT03068494, which also lists 9 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 8 May 2019.

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