Coronary Artery DiseaseDecisionCTO10YNCT06908499
The DECISION-CTO Extended 10 Y Follow-up
An observational study of Coronary Artery Disease, run by Seung-Jung Park at 19 sites in 5 countries.
Trial summary
The goal of this study is to compare the 10-year clinical outcomes of an initial strategy of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO-PCI) with an initial strategy of no CTO-PCI in patients with chronic total occlusion who were enrolled in the DECISION-CTO trial (NCT01078051) Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 804 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 1 Apr 2026to 24 Aug 2026
- 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
- Adult, Older adult
Study population: Patients with chronic total occlusion who were enrolled in the original DECISION-CTO trial (NCT01078051)
Who may be able to join
- Clinical 1) Patients with angina or silent ischemia and documented ischemia 2) Patients who are eligible for intracoronary stenting 3) Age >18 years
- Angiographic 1) De novo lesion Chronic Total Occlusion (CTO) 2) Reference vessel size ≥ 2.5 mm by visual estimation 3) At least one CTO lesions located in proximal or mid epicardial coronary artery.
- (If the patient has two CTO lesions, one CTO lesion should be located in proximal or mid epicardial coronary artery)
- CTO definition: TIMI (Thrombolysis in Myocardial Infarction) flow 0 or 1 with estimated duration over 3 months
- The duration of the occlusion was determined by the interval from the last episode of acute coronary syndrome, or
- In patients without a history of acute coronary syndrome, from the first episode of effort angina consistent with the location of the occlusion
- Angiographically defined total occlusion over 3 months
- If no definite symptom with total occlusion, two experienced operators decide CTO in consideration of angiographical morphology (degree of calcification, bridging collaterals, non-tapered stump, angiographic filling from collaterals)
Who cannot join
- History of bleeding diathesis or coagulopathy
- Pregnant state
- Three vessel CTOs
- Known hypersensitivity or contra-indication to contrast agent and heparin
- ST-elevation acute myocardial infarction requiring primary stenting
- Culprit total occlusion presented with acute coronary syndrome suggesting acute or recent occlusion
Show all 14Show fewer
- Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels 4) Distal epicardial coronary artery CTO lesions 5) Two vessel proximal segment CTOs
- Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3)
- Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal
- Renal dysfunction, creatinine ≥ 2.0mg/dL
- Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent
- Left ventricular ejection fraction <30%
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Non-cardiac co-morbid conditions are present with limited life expectancy or that may result in protocol non-compliance (per site investigator's medical judgment).
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
South Korea15 sites
SAM hospital
Anyang
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Dong-A Medical Center
Busan
Kangwon National University Hospital
Chuncheon
Keimyung University Dongsan Medical Center
Daegu
Chungnam National University Hospital
Daejeon
The Catholic University of Korea, Daejeon St. Mary's Hosptial
Daejeon
Gangneung Asan Hospital
Gangneung
Chonnam National University Hospital
Gwangju
Bundang CHA Hospital
Seongnam
Asan Medical Center
Seoul
Hallym University Hangang Sacred Heart Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Guro Hospital
Seoul
Ulsan University Hospital
Ulsan
About this study
Official title: Ten-Year Outcomes of Initial CTO-PCI Versus No CTO-PCI Strategies in Patients With Chronic Total Occlusion: Extended Follow-Up of the DECISION-CTO Trial
The goal of this study is to compare the 10-year clinical outcomes of an initial strategy of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO-PCI) with an initial strategy of no CTO-PCI in patients with chronic total occlusion who were enrolled in the DECISION-CTO trial (NCT01078051)
- Conditions
- Coronary Artery Disease
- Keywords
- Chronic Total Occlusion, Drug-eluting Stent Implantation, Optimal Medical Treatment
- Medical subject headings
- Coronary Artery Disease
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 |
|---|---|---|
| Patients with chronic total occlusion | Patients with chronic total occlusion who were enrolled in the original DECISION-CTO trial (NCT01078051) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event rate of the composite event
The composite of death from any cause, myocardial infarction, stroke, or any revascularization at 10 years after randomization
Measured: 10 years
Secondary outcomes (4)
Event rate of all cause death
Measured: 10 years
Event rate of myocardial infarction
Measured: 10 years
Event rate of stroke
Measured: 10 years
Event rate of any 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 posted3 Apr 2025
- Study start1 Apr 2026
- Primary completion24 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 804 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
- NCT06908499
- Sponsor's protocol ID
- AMCCV2025-01
- Acronym
- DecisionCTO10Y
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ten-Year Outcomes of Initial CTO-PCI Versus No CTO-PCI Strategies in Patients With Chronic Total Occlusion: Extended Follow-Up of the DECISION-CTO Trial
- ClinicalTrials.gov ID
- NCT06908499
- Acronym / sponsor ID
- DecisionCTO10Y / AMCCV2025-01
- Conditions
- Coronary Artery Disease
- Keywords
- Chronic Total Occlusion, Drug-eluting Stent Implantation, Optimal Medical Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 3 Apr 2025 (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.
The goal of this study is to compare the 10-year clinical outcomes of an initial strategy of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO-PCI) with an initial strategy of no CTO-PCI in patients with chronic total occlusion who were enrolled in the DECISION-CTO trial (NCT01078051)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic total occlusion | – | –Patients with chronic total occlusion who were enrolled in the original DECISION-CTO trial (NCT01078051) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic total occlusion who were enrolled in the original DECISION-CTO trial (NCT01078051)
Key inclusion criteria (8 listed)
- Clinical 1) Patients with angina or silent ischemia and documented ischemia 2) Patients who are eligible for intracoronary stenting 3) Age >18 years
- Angiographic 1) De novo lesion Chronic Total Occlusion (CTO) 2) Reference vessel size ≥ 2.5 mm by visual estimation 3) At least one CTO lesions located in proximal or mid epicardial coronary artery.
- (If the patient has two CTO lesions, one CTO lesion should be located in proximal or mid epicardial coronary artery)
- CTO definition: TIMI (Thrombolysis in Myocardial Infarction) flow 0 or 1 with estimated duration over 3 months
Key exclusion criteria (14 listed)
- History of bleeding diathesis or coagulopathy
- Pregnant state
- Three vessel CTOs
- Known hypersensitivity or contra-indication to contrast agent and heparin
- ST-elevation acute myocardial infarction requiring primary stenting
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
Event rate of the composite event
Time frame: 10 years
The composite of death from any cause, myocardial infarction, stroke, or any revascularization at 10 years after randomization
4 secondary outcomes
Event rate of all cause death
Time frame: 10 years
Event rate of myocardial infarction
Time frame: 10 years
Event rate of stroke
Time frame: 10 years
Event rate of any revascularization
Time frame: 10 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 26 Oct 2026.
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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 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Seung-Jung Park at 19 sites in 5 countries.
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 8 inclusion and 14 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 Oct 2026. 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, India, Indonesia, Taiwan, Thailand. 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?
Event rate of the 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?
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 Oct 2026.