ClinicalTrials.gg
CompletedNCT06908499DecisionCTO10YUpdated Oct 26, 2026

The DECISION-CTO Extended 10 Y Follow-up

An observational study in Coronary Artery Disease, sponsored by Seung-Jung Park. Completed at 19 sites in 5 countries. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Seung-Jung Park · Observational

Updated Oct 26, 2026Now CompletedPrimary completion moved+5 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
804
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 59 studies in Coronary Artery Disease by Seung-Jung Park — 11 open to participants now, 13 under way, none of them phase 3. Coronary Artery Disease · Seung-Jung Park.

Enrollment
23rd of 30
804 · median 2,000
Started
2026
the only one that year
Observational
30 of 59
10 open now
Registered
59th of 59
by date

Among the 59 studies in Coronary Artery Disease by Seung-Jung Park, this one is the 23rd largest by enrollment of the 30 observational ones that give a count, is the only one that started in 2026, is one of 30 observational ones, and was the 59th registered.

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

11 of the 59 studies in Coronary Artery Disease by Seung-Jung Park are open now, in 8 countries. Recruiting first, the newest first:

6 more — sign in →

By country, each count listing its studies:

All 11 open studies →

Who these studies take

Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.

This study: 19 Years and older · all sexes.

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02

Study 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)

03

Conditions studied

  • Coronary Artery Disease

Keywords

  • Chronic Total Occlusion
  • Drug-eluting Stent Implantation
  • Optimal Medical Treatment
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with chronic total occlusion who were enrolled in the original DECISION-CTO trial (NCT01078051)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Clinical 1) Patients with angina or silent ischemia and documented ischemia 2) Patients who are eligible for intracoronary stenting 3) Age >18 years
  2. 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)

  3. 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

      1. Angiographically defined total occlusion over 3 months
      2. 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)

Exclusion criteria

Exclusion Criteria:

  1. History of bleeding diathesis or coagulopathy
  2. Pregnant state
  3. Three vessel CTOs
  4. Known or to contrast agent and heparin
  5. ST-elevation acute myocardial infarction requiring primary stenting
  6. Culprit total occlusion presented with acute coronary syndrome suggesting acute or recent occlusion
  7. 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
  8. Hematological disease (Neutropenia \<3000/mm3, Thrombocytopenia \<100,000/mm3)
  9. Hepatic dysfunction, liver enzyme ( and AST) elevation ≥ 3 times normal
  10. Renal dysfunction, creatinine ≥ 2.0mg/dL
  11. Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent
  12. \<30%
  13. Patients who are actively participating in another drug or device study, which have not completed the primary endpoint follow-up period.
  14. Non-cardiac co-morbid conditions are present with limited or that may result in protocol non-compliance (per site investigator's medical judgment).
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
804 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with chronic total occlusion

    Patients with chronic total occlusion who were enrolled in the original DECISION-CTO trial (NCT01078051)

06

What researchers measure

Primary outcomes

  1. Event rate of the composite event

    The composite of death from any cause, myocardial infarction, stroke, or any revascularization at 10 years after randomization

    Time frame: 10 years

Secondary outcomes

  1. Event rate of all cause death

    Time frame: 10 years

  2. Event rate of myocardial infarction

    Time frame: 10 years

  3. Event rate of stroke

    Time frame: 10 years

  4. Event rate of any revascularization

    Time frame: 10 years

07

Study locations

19 sites
  • Ruby Hall Clinic
    Pune, Maharashtra 411001, India
  • Medistra Hospital
    Jakarta, DKI Jakarta 12950, Indonesia
  • SAM hospital
    Anyang, South Korea
  • Soon Chun Hyang University Hospital Bucheon
    Bucheon-si, South Korea
  • Dong-A Medical Center
    Busan, South Korea
  • Kangwon National University Hospital
    Chuncheon, South Korea
  • Keimyung University Dongsan Medical Center
    Daegu, South Korea
  • Chungnam National University Hospital
    Daejeon, South Korea
  • The Catholic University of Korea, Daejeon St. Mary's Hosptial
    Daejeon, South Korea
  • Gangneung Asan Hospital
    Gangneung, South Korea
  • Chonnam National University Hospital
    Gwangju, South Korea
  • Bundang CHA Hospital
    Seongnam, South Korea
  • Asan Medical Center
    Seoul, South Korea
  • Hallym University Hangang Sacred Heart Hospital
    Seoul, South Korea
  • Kangbuk Samsung Hospital
    Seoul, South Korea
  • Korea University Guro Hospital
    Seoul, South Korea
  • Ulsan University Hospital
    Ulsan, South Korea
  • Shin Kong Wu Ho-Su Memorial Hospital
    Taipei, Taipei City 111013, Taiwan
  • King Chulalongkorn Memorial Hospital
    Bangkok, Bangkok 10330, Thailand
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Apr 2026 to primary completion in Aug 2026, 4 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 26, 2026: primary completion Jul 2026 → Aug 2026 and completion Dec 2026 → Aug 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2025
First posted
Apr 3, 2025
StartActual
Apr 1, 2026
Primary completionActual
Aug 24, 2026was Jul 2026
CompletionActual
Aug 24, 2026was Dec 2026
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 26, 2026
Sites
1 site added, 1 site removed
Show site
  • King Chulalongkorn Memorial Hospital · Bangkok, Thailand
Show 1 removed
  • King Chulalongkorn Memorial Hospital · Bangkok, Thailand
Oct 26, 2026
Primary completion
Jul 30, 2026→Aug 24, 2026 (actual)
Oct 26, 2026
Study completion
Dec 31, 2026→Aug 24, 2026 (actual)
Oct 26, 2026
Enrollment
840 (estimated)→804 (actual)
Oct 26, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionEvent rate of the composite event: how it is measured was reworded
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Recruiting→Completed
    1 site added, 1 site removed
    Show site
    • King Chulalongkorn Memorial Hospital · Bangkok, Thailand
    Show 1 removed
    • King Chulalongkorn Memorial Hospital · Bangkok, Thailand
    Primary completion Jul 30, 2026→Aug 24, 2026 (now actual)
    Study completion Dec 31, 2026→Aug 24, 2026 (now actual)
    Enrollment 840 (estimated)→804 (actual)
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionEvent rate of the composite event: how it is measured was reworded
    + 5 other changes: identifiers, verification date, responsible party, description and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06908499
Lead sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Seung-Jung Park (Principal Investigator, Asan Medical Center) — Sponsor-investigator
First posted
Apr 3, 2025
Start date
Apr 1, 2026
Primary completion
Aug 24, 2026
Completion
Aug 24, 2026
Last update
Oct 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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