Coronary OcclusionIRIS CTONCT04041921
Chronic Total Occlusion Registry
An observational study of Coronary Occlusion and Coronary Artery Stenosis, run by Seung-Jung Park at 19 sites in South Korea.
Trial summary
This study evaluated the long-term outcome of patients with chronic total occlusion treated with percutaneous coronary intervention, medical treatment or coronary artery bypass grafting. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Occlusion, Coronary Artery Stenosis, Coronary Stenosis
- What is being tested?
- Percutaneous coronary intervention, Coronary Artery Bypass Grafting and Medical treatment
- Type of treatment
- Surgery or procedure
- How many people
- 4,006 participants
- Where
- 19 sitesSouth Korea
- Study dates
- Jan 2010to 8 Apr 2022
- How long will I take part?
- 10 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 De novo chronic coronary occlusion ≥ 3months and reference diameter ≥ 2.5 mm on coronary angiography
Who may be able to join
- Patients with angina or silent ischemia and documented ischemia
- Patients with De novo chronic coronary occlusion ≥ 3months and reference diameter ≥ 2.5 mm on coronary angiography
- Age > 18 years
Who cannot join
- Refuse to participate in this study
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
South Korea19 sites
SAM hospital
Anyang
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Soon Chun Hyang University Hospital Cheonan
Cheonan
Chungbuk National University Hospital
Cheongju-si
Gangwon National Univ. Hospital
Chuncheon
Keimyung University Dongsan Medical Center
Daegu
Chungnam National University Hospital
Daejeon
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
Gangneung Asan Hospital
Gangneung
Chonnam National University Hospital
Gwangju
ChonBuk National University Hospital
Jeonju
Dong-A Medical Center
Pusan
Pusan National University Yangsan Hospital
Pusan
Bundang CHA Hospital
Seongnam
Asan Medical Hospital
Seoul
Korea University Guro Hospital
Seoul
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
Ulsan University Hospital
Ulsan
Wonju Severance Christian Hospital
Wŏnju
About this study
Official title: A Multicenter, Prospective, Real World Observational Study for Chronic Total Occlusion
This study evaluated the long-term outcome of patients with chronic total occlusion treated with percutaneous coronary intervention, medical treatment or coronary artery bypass grafting.
Read the detailed description
This study is connected with Decision-CTO trial(NCT01078051). Randomized subjects and registry group subjects from Decision-CTO trial continue 10 years follow-up on this study.
- Being tested
- Percutaneous coronary intervention, Coronary Artery Bypass Grafting, Medical treatment
- Keywords
- CTO, PCI, CABG, Medical treatment, Decision CTO
- Medical subject headings
- Coronary Occlusion, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
Coronary Artery Bypass GraftingProcedure or surgery
Medical treatmentDrug
| Study group | Role | What they receive |
|---|---|---|
| Chronic coronary occlusion patients | ≥3 months chronic total occlusion on coronary angiography Receives: Procedure: Percutaneous coronary intervention; Procedure: Coronary Artery Bypass Grafting; Drug: Medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite event of all cause death, myocardial infarction, stroke or all kinds of repeat revascularization
Measured: 10 years
Secondary outcomes (9)
Event rate of all cause death
Measured: 10 years
Event rate of acute myocardial infarction
Measured: 10 years
Event rate of stroke
Measured: 10 years
Event rate of repeat revascularization
Measured: 10 years
Event rate of rehospitalization due to acute coronary syndrome
Measured: 10 years
The rate change of left ventricular ejection fraction
Measured: 10 years
Composite event of death, myocardial, stroke or repeat revascularization
Measured: 5 years
Composite event of death, myocardial, stroke or repeat revascularization
Measured: 10 years
Event rate of Procedural success
Procedural success is defined as < 30% final stenosis and the absence of in-hospital event including death, Q-wave myocardial infarction or urgent repeat revascularization.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study startJan 2010
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
Why it stopped: The purpose of this study is no longer maintained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary OcclusionStudies 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
- Prospective
- Enrolment
- 4,006 participants (actual)
- Target duration
- 10 Years
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
- NCT04041921
- Sponsor's protocol ID
- CVRF2009-06
- Acronym
- IRIS CTO
- Status last verified
- Apr 2022
- First submitted
- 25 Jul 2019
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Real World Observational Study for Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT04041921
- Acronym / sponsor ID
- IRIS CTO / CVRF2009-06
- Keywords
- CTO, PCI, CABG, Medical treatment, Decision CTO
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The purpose of this study is no longer maintained
- Enrolment
- 4,006 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Jan 2010 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 1 Aug 2019 (actual)
- 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.
This study evaluated the long-term outcome of patients with chronic total occlusion treated with percutaneous coronary intervention, medical treatment or coronary artery bypass grafting.
Detailed description
This study is connected with Decision-CTO trial(NCT01078051). Randomized subjects and registry group subjects from Decision-CTO trial continue 10 years follow-up on this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic coronary occlusion patients | – | Procedure: Percutaneous coronary intervention, Procedure: Coronary Artery Bypass Grafting, Drug: Medical treatment≥3 months chronic total occlusion on coronary angiography |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with De novo chronic coronary occlusion ≥ 3months and reference diameter ≥ 2.5 mm on coronary angiography
Key inclusion criteria (3 listed)
- Patients with angina or silent ischemia and documented ischemia
- Patients with De novo chronic coronary occlusion ≥ 3months and reference diameter ≥ 2.5 mm on coronary angiography
- Age > 18 years
Key exclusion criteria (1 listed)
- Refuse to participate in this study
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 | Procedure or surgery | Chronic coronary occlusion patients |
| Coronary Artery Bypass Grafting | Procedure or surgery | Chronic coronary occlusion patients |
| Medical treatment | Drug | Chronic coronary occlusion patients |
Primary outcome
Composite event of all cause death, myocardial infarction, stroke or all kinds of repeat revascularization
Time frame: 10 years
9 secondary outcomes
Event rate of all cause death
Time frame: 10 years
Event rate of acute myocardial infarction
Time frame: 10 years
Event rate of stroke
Time frame: 10 years
Event rate of repeat revascularization
Time frame: 10 years
Event rate of rehospitalization due to acute coronary syndrome
Time frame: 10 years
The rate change of left ventricular ejection fraction
Time frame: 10 years
Composite event of death, myocardial, stroke or repeat revascularization
Time frame: 5 years
Composite event of death, myocardial, stroke or repeat revascularization
Time frame: 10 years
Event rate of Procedural success
Time frame: 5 days
Results and safety
The study was stopped early (reason given: The purpose of this study is no longer maintained). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
19 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 Occlusion and Coronary Artery Stenosis, run by Seung-Jung Park at 19 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 3 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: stopped early, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 was stopped early (reason given: The purpose of this study is no longer maintained). Results are not available in the source record.
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 of all cause death, myocardial infarction, stroke or all kinds of repeat revascularization (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2022.