Coronary ArteriesMAIN COMPARENCT02791412
Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease
An observational study of Coronary Arteries, run by Seung-Jung Park at 12 sites in South Korea.
Trial summary
The purpose of this study is to evaluate long-term outcome of treatment(percutaneous coronary intervention or coronary-artery bypass graft) in unprotected left main coronary artery stenosis in Korea. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Arteries
- What is being tested?
- percutaneous coronary intervention or coronary-artery bypass graft
- Type of treatment
- Surgery or procedure
- How many people
- 2,240 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 13 Jan 2017to 30 May 2018
- 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 undergone percutaneous coronary intervention or coronary-artery bypass graft for treatment of unprotected left main disease
Who may be able to join
- Unprotected left main disease
Who cannot join
- No exclusion criteria
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Kyungpook National University Hospital
Daegu
Chungnam National University Hospital
Daejeon
Chonnam National University Hospital
Gwangju
Gachon University Gil Hospital
Incheon
Asan Medical Center
Seoul, Songpa-gu, 138-736
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul
Seoul National University Bundang hospital
Sungnam
Ajou University Hospital
Suwon
About this study
Official title: Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease in Korea : Multicenter, Long-term, Observational Trial
The purpose of this study is to evaluate long-term outcome of treatment(percutaneous coronary intervention or coronary-artery bypass graft) in unprotected left main coronary artery stenosis in Korea.
- Conditions
- Coronary Arteries
- Being tested
- percutaneous coronary intervention or coronary-artery bypass graft
- Keywords
- left main, unprotected, percutaneous coronary intervention, coronary-artery bypass graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary intervention or coronary-artery bypass graftProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| unprotected left main | undergone percutaneous coronary intervention or coronary artery bypass graft Receives: Procedure: percutaneous coronary intervention or coronary-artery bypass graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite event
all-cause death, myocardiac infarction, revascularization
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study start13 Jan 2017
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary ArteriesStudies of the same condition, open and under way.
- 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
- 2,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791412
- Sponsor's protocol ID
- AMCCV2016-08
- Acronym
- MAIN COMPARE
- Status last verified
- Jun 2018
- First submitted
- 30 May 2016
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not a publicly funded trial.
Publications
Kim TO, Kang DY, Ahn JM, Kim MJ, Lee PH, Kim H, Choi Y, Lee J, Lee JM, Jo HH, Park YS, Lim SM, Park SJ, Park DW. Impact of Target Lesion Revascularization on Long-Term Mortality After Percutaneous Coronary Intervention for Left Main Disease. JACC Cardiovasc Interv. 2024 Jan 8;17(1):32-42. doi: 10.1016/j.jcin.2023.10.068.
PubMed 38199751Yoon YH, Ahn JM, Lee JB, Kang DY, Park H, Jeong YJ, Lee J, Kim JH, Yang Y, Hyun J, Lee PH, Park DW, Park SJ. Time-Dependent Impact of Sex on the Long-Term Outcomes After Left Main Revascularization. J Am Heart Assoc. 2022 Mar;11(5):e021720. doi: 10.1161/JAHA.121.021720. Epub 2022 Feb 22.
PubMed 35189706Kang DY, Ahn JM, Yun SC, Park H, Cho SC, Kim TO, Park S, Lee PH, Lee SW, Park SW, Park DW, Park SJ. Long-Term Clinical Impact of Intravascular Ultrasound Guidance in Stenting for Left Main Coronary Artery Disease. Circ Cardiovasc Interv. 2021 Oct;14(10):e011011. doi: 10.1161/CIRCINTERVENTIONS.121.011011. Epub 2021 Oct 19.
PubMed 34665659Lee K, Ahn JM, Yoon YH, Kang DY, Park SY, Ko E, Park H, Cho SC, Park S, Kim TO, Lee PH, Lee SW, Park SW, Park DW, Park SJ. Long-Term (10-Year) Outcomes of Stenting or Bypass Surgery for Left Main Coronary Artery Disease in Patients With and Without Diabetes Mellitus. J Am Heart Assoc. 2020 Apr 21;9(8):e015372. doi: 10.1161/JAHA.119.015372. Epub 2020 Apr 20.
PubMed 32310027Kim TO, Ahn JM, Kang DY, Kim SO, Park S, Park H, Lee PH, Lee SW, Park SW, Park DW, Park SJ. Rates and Independent Correlates of 10-Year Major Adverse Events and Mortality in Patients Undergoing Left Main Coronary Arterial Revascularization. Am J Cardiol. 2020 Apr 15;125(8):1148-1153. doi: 10.1016/j.amjcard.2020.01.023. Epub 2020 Jan 29.
PubMed 32085865Yoon YH, Ahn JM, Kang DY, Park H, Cho SC, Lee PH, Lee SW, Park SW, Park DW, Park SJ. Impact of SYNTAX Score on 10-Year Outcomes After Revascularization for Left Main Coronary Artery Disease. JACC Cardiovasc Interv. 2020 Feb 10;13(3):361-371. doi: 10.1016/j.jcin.2019.10.020.
PubMed 32029254Park DW, Ahn JM, Yun SC, Yoon YH, Kang DY, Lee PH, Lee SW, Park SW, Seung KB, Gwon HC, Jeong MH, Jang Y, Kim HS, Seong IW, Park HS, Ahn T, Chae IH, Tahk SJ, Park SJ. 10-Year Outcomes of Stents Versus Coronary Artery Bypass Grafting for Left Main Coronary Artery Disease. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2813-2822. doi: 10.1016/j.jacc.2018.09.012. Epub 2018 Sep 24.
PubMed 30261236
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease in Korea : Multicenter, Long-term, Observational Trial
- ClinicalTrials.gov ID
- NCT02791412
- Acronym / sponsor ID
- MAIN COMPARE / AMCCV2016-08
- Conditions
- Coronary Arteries
- Keywords
- left main, unprotected, percutaneous coronary intervention, coronary-artery bypass graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,240 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 6 Jun 2016 (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 purpose of this study is to evaluate long-term outcome of treatment(percutaneous coronary intervention or coronary-artery bypass graft) in unprotected left main coronary artery stenosis in Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| unprotected left main | – | Procedure: percutaneous coronary intervention or coronary-artery bypass graftundergone percutaneous coronary intervention or coronary artery bypass graft |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergone percutaneous coronary intervention or coronary-artery bypass graft for treatment of unprotected left main disease
Key inclusion criteria (1 listed)
- Unprotected left main disease
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous coronary intervention or coronary-artery bypass graft | Procedure or surgery | unprotected left main |
Primary outcome
composite event
Time frame: 10 years
all-cause death, myocardiac infarction, revascularization
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 26 Jun 2018.
- Derived from this study: PubMed 38199751Kim TO, Kang DY, Ahn JM, Kim MJ, Lee PH, Kim H, Choi Y, Lee J, Lee JM, Jo HH, Park YS, Lim SM, Park SJ, Park DW. Impact of Target Lesion Revascularization on Long-Term Mortality After Percutaneous Coronary Intervention for Left Main Disease. JACC Cardiovasc Interv. 2024 Jan 8;17(1):32-42. doi: 10.1016/j.jcin.2023.10.068.
- Derived from this study: PubMed 35189706Yoon YH, Ahn JM, Lee JB, Kang DY, Park H, Jeong YJ, Lee J, Kim JH, Yang Y, Hyun J, Lee PH, Park DW, Park SJ. Time-Dependent Impact of Sex on the Long-Term Outcomes After Left Main Revascularization. J Am Heart Assoc. 2022 Mar;11(5):e021720. doi: 10.1161/JAHA.121.021720. Epub 2022 Feb 22.
- Derived from this study: PubMed 34665659Kang DY, Ahn JM, Yun SC, Park H, Cho SC, Kim TO, Park S, Lee PH, Lee SW, Park SW, Park DW, Park SJ. Long-Term Clinical Impact of Intravascular Ultrasound Guidance in Stenting for Left Main Coronary Artery Disease. Circ Cardiovasc Interv. 2021 Oct;14(10):e011011. doi: 10.1161/CIRCINTERVENTIONS.121.011011. Epub 2021 Oct 19.
- Derived from this study: PubMed 32310027Lee K, Ahn JM, Yoon YH, Kang DY, Park SY, Ko E, Park H, Cho SC, Park S, Kim TO, Lee PH, Lee SW, Park SW, Park DW, Park SJ. Long-Term (10-Year) Outcomes of Stenting or Bypass Surgery for Left Main Coronary Artery Disease in Patients With and Without Diabetes Mellitus. J Am Heart Assoc. 2020 Apr 21;9(8):e015372. doi: 10.1161/JAHA.119.015372. Epub 2020 Apr 20.
- Derived from this study: PubMed 32085865Kim TO, Ahn JM, Kang DY, Kim SO, Park S, Park H, Lee PH, Lee SW, Park SW, Park DW, Park SJ. Rates and Independent Correlates of 10-Year Major Adverse Events and Mortality in Patients Undergoing Left Main Coronary Arterial Revascularization. Am J Cardiol. 2020 Apr 15;125(8):1148-1153. doi: 10.1016/j.amjcard.2020.01.023. Epub 2020 Jan 29.
- Derived from this study: PubMed 32029254Yoon YH, Ahn JM, Kang DY, Park H, Cho SC, Lee PH, Lee SW, Park SW, Park DW, Park SJ. Impact of SYNTAX Score on 10-Year Outcomes After Revascularization for Left Main Coronary Artery Disease. JACC Cardiovasc Interv. 2020 Feb 10;13(3):361-371. doi: 10.1016/j.jcin.2019.10.020.
- Derived from this study: PubMed 30261236Park DW, Ahn JM, Yun SC, Yoon YH, Kang DY, Lee PH, Lee SW, Park SW, Seung KB, Gwon HC, Jeong MH, Jang Y, Kim HS, Seong IW, Park HS, Ahn T, Chae IH, Tahk SJ, Park SJ. 10-Year Outcomes of Stents Versus Coronary Artery Bypass Grafting for Left Main Coronary Artery Disease. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2813-2822. doi: 10.1016/j.jacc.2018.09.012. Epub 2018 Sep 24.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arteries, run by Seung-Jung Park at 12 sites 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 1 inclusion and 1 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 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
composite event (time frame: 10 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 NCT02791412, 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 26 Jun 2018.