Coronary Bifurcation LesionCOBISNCT00851526
Coronary Bifurcation Stenting (COBIS) Registry in South Korea
An observational study of Coronary Bifurcation Lesion, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. 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
- 1,919 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2004to Dec 2008
- 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 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
Who cannot join
- Cardiogenic Shock
- ST elevation MI within 48hours
- Expected survival less than 1 year
- Left main bifurcation
- Allergy to the antiplatelets
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Coronary Bifurcation Lesion
- 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 group | Role | What they receive |
|---|---|---|
| Coronary bifurcation lesion | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the composite outcome of all-cause death, MI, or any PCI/CABG
Measured: 3 years
Secondary outcomes (1)
Incidence of stent thrombosis, and periprocedural MI
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startJan 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Bifurcation LesionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,919 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeon-Cheol Gwon, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851526
- Sponsor's protocol ID
- 2007-04-042
- Acronym
- COBIS
- Status last verified
- Jul 2012
- First submitted
- 25 Feb 2009
- Last updated
- 17 Jul 2012
- Results posted
- No
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.
PubMed 25262126Chung 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.
PubMed 23486858Song 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.
PubMed 22494861Gwon 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.
PubMed 21933939Gwon 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.
PubMed 20890049Song 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.
PubMed 20394879
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Bifurcation Stenting (COBIS) Registry in South Korea
- ClinicalTrials.gov ID
- NCT00851526
- Acronym / sponsor ID
- COBIS / 2007-04-042
- Conditions
- Coronary Bifurcation Lesion
- Keywords
- Coronary bifurcation lesion, Drug-eluting stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,919 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 26 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary bifurcation lesion | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary bifurcation lesion treated with drug-eluting stents
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Cardiogenic Shock
- ST elevation MI within 48hours
- Expected survival less than 1 year
- Left main bifurcation
- Allergy to the antiplatelets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of the composite outcome of all-cause death, MI, or any PCI/CABG
Time frame: 3 years
1 secondary outcome
Incidence of stent thrombosis, and periprocedural MI
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
- Derived from this study: PubMed 25262126Song 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.
- Derived from this study: PubMed 23486858Chung 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.
- Derived from this study: PubMed 22494861Song 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.
- Derived from this study: PubMed 21933939Gwon 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.
- Derived from this study: PubMed 20890049Gwon 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.
- Derived from this study: PubMed 20394879Song 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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 3 inclusion and 5 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 17 Jul 2012. 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 outcome of all-cause death, MI, or any PCI/CABG (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 NCT00851526, which also lists 6 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 17 Jul 2012.