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TerminatedNCT04041921IRIS CTOUpdated Apr 18, 2022

Chronic Total Occlusion Registry

An observational study in Coronary Occlusion, Coronary Artery Stenosis and Coronary Stenosis, sponsored by Seung-Jung Park. Terminated at 19 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-04-18.

Sponsored by Seung-Jung Park · Observational

Why this study was terminated
The purpose of this study is no longer maintained
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,006
Ages
19 Years and older
Sex
All
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Study 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 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.

02

Conditions studied

  • Coronary Occlusion
  • Coronary Artery Stenosis
  • Coronary Stenosis

Keywords

  • CTO
  • PCI
  • CABG
  • Medical treatment
  • Decision CTO
03

In context

Coronary Stenosis

302 studies on the registry are indexed under Coronary Stenosis; 63 are open to participants now.

This study's enrollment of 4,006 is above the median of 200 across 132 observational studies indexed under Coronary Stenosis.

Browse Coronary Stenosis studies →

Lead sponsor

Seung-Jung Park is the lead sponsor of 82 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with De novo chronic coronary occlusion ≥ 3months and reference diameter ≥ 2.5 mm on coronary angiography

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Refuse to participate in this study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,006 participants (actual)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Chronic coronary occlusion patients

    ≥3 months chronic total occlusion on coronary angiography

    Procedure: Percutaneous coronary intervention · Procedure: Coronary Artery Bypass Grafting · Drug: Medical treatment

Interventions

  • ProcedurePercutaneous coronary intervention
  • ProcedureCoronary Artery Bypass Grafting
  • DrugMedical treatment
06

What researchers measure

Primary outcomes

  1. Composite event of all cause death, myocardial infarction, stroke or all kinds of repeat revascularization

    Time frame: 10 years

Secondary outcomes

  1. Event rate of all cause death

    Time frame: 10 years

  2. Event rate of acute myocardial infarction

    Time frame: 10 years

  3. Event rate of stroke

    Time frame: 10 years

  4. Event rate of repeat revascularization

    Time frame: 10 years

  5. Event rate of rehospitalization due to acute coronary syndrome

    Time frame: 10 years

  6. The rate change of left ventricular ejection fraction

    Time frame: 10 years

  7. Composite event of death, myocardial, stroke or repeat revascularization

    Time frame: 5 years

  8. Composite event of death, myocardial, stroke or repeat revascularization

    Time frame: 10 years

  9. 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.

    Time frame: 5 days

07

Study locations

19 sites
  • SAM hospital
    Anyang, Korea, Republic of
  • Soon Chun Hyang University Hospital Bucheon
    Bucheon, Korea, Republic of
  • Soon Chun Hyang University Hospital Cheonan
    Cheonan, Korea, Republic of
  • Chungbuk National University Hospital
    Cheongju, Korea, Republic of
  • Gangwon National Univ. Hospital
    Chuncheon, Korea, Republic of
  • Keimyung University Dongsan Medical Center
    Daegu, Korea, Republic of
  • Chungnam National University Hospital
    Daejeon, Korea, Republic of
  • The Catholic University of Korea, Daejeon ST. Mary's Hospital
    Daejeon, Korea, Republic of
  • Gangneung Asan Hospital
    Gangneung, Korea, Republic of
  • Chonnam National University Hospital
    Gwangju, Korea, Republic of
  • ChonBuk National University Hospital
    Jeonju, Korea, Republic of
  • Dong-A Medical Center
    Pusan, Korea, Republic of
  • Pusan National University Yangsan Hospital
    Pusan, Korea, Republic of
  • Bundang CHA Hospital
    Seongnam, Korea, Republic of
  • Asan Medical Hospital
    Seoul, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, Korea, Republic of
  • The Catholic University of Korea Seoul St. Mary's Hospital
    Seoul, Korea, Republic of
  • Ulsan University Hospital
    Ulsan, Korea, Republic of
  • Wonju Severance Christian Hospital
    Wonju, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04041921
Lead sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Seung-Jung Park (Professor,University of Ulsan College of Medicine, Asan Medical Center) — Sponsor-investigator
First posted
Aug 1, 2019
Start date
Jan 2010
Primary completion
Apr 8, 2022
Completion
Apr 8, 2022
Last update
Apr 18, 2022

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 terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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