The DECISION-CTO Extended 10 Y Follow-up (DecisionCTO10Y)

December 21, 2025 updated by: Seung-Jung Park

Ten-Year Outcomes of Randomized Comparison of Drug-eluting Stent Implantation Versus Optimal Medical Treatment in Patient With Chronic Total Occlusion: DECISION-CTO Trial

The goal of this clinical trial is to compare long term efficacy of drug-eluting stent implantation compare to optimal medical treatment in patient with chronic total occlusion in a very long-term follow-up (minimum 10 years) period.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

840

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Maharashtra
      • Pune, Maharashtra, India, 411001
        • Ruby Hall Clinic
        • Contact:
          • Shirish Hiremath, MD
        • Principal Investigator:
          • Shirish Hiremath, MD
  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 12950
        • Medistra Hospital
        • Contact:
          • Teguh Santoso, MD
        • Principal Investigator:
          • Teguh Santoso, MD
  • South Korea
      • Anyang, South Korea
        • SAM hospital
        • Contact:
          • Il-woo Seo, MD
        • Principal Investigator:
          • Il-woo Seo, MD
      • Bucheon-si, South Korea
        • Soon Chun Hyang University Hospital Bucheon
        • Contact:
          • John Seo, MD
        • Principal Investigator:
          • John Seo, MD
      • Busan, South Korea
        • Dong-A Medical Center
        • Contact:
          • Sang-yong Cho, MD
        • Principal Investigator:
          • Sang-yong Cho, MD
      • Chuncheon, South Korea
        • Kangwon National University Hospital
        • Contact:
          • Bong-ki Lee, MD
        • Principal Investigator:
          • Bong-Ki Lee, MD
      • Daegu, South Korea
        • Keimyung University Dongsan Medical Center
        • Contact:
          • Hyuk-joon Yoon, MD
        • Principal Investigator:
          • Hyuk-joon Yoon, MD
      • Daejeon, South Korea
        • Chungnam National University Hospital
        • Contact:
          • Jae-whan Lee, MD
        • Principal Investigator:
          • Jae-whan Lee, MD
      • Daejeon, South Korea
        • The Catholic University of Korea, Daejeon St. Mary's Hosptial
        • Contact:
          • Kyu-seob Lee, MD
        • Principal Investigator:
          • Kyu-seob Lee, MD
      • Gangneung, South Korea
        • GangNeung Asan Hospital
        • Contact:
          • Han-bit Park, MD
        • Principal Investigator:
          • Han-bit Park, MD
      • Gwangju, South Korea
        • Chonnam National University Hospital
        • Contact:
          • Min-cheol Kim, MD
        • Principal Investigator:
          • Min-cheol Kim, MD
      • Seongnam, South Korea
        • Bundang CHA hospital
        • Contact:
          • Sang-wook Lim, MD
        • Principal Investigator:
          • Sang-wook Lim, MD
      • Seoul, South Korea
        • Asan Medical Center
        • Contact:
          • Seung-Jung Park, MD
        • Principal Investigator:
          • Seung-jung Park, MD
      • Seoul, South Korea
        • Kangbuk Samsung Hospital
        • Contact:
          • Seung-Jae Lee, MD
        • Principal Investigator:
          • Seung-Jae Lee, MD
      • Seoul, South Korea
        • Korea University Guro Hospital
        • Principal Investigator:
          • Seung-woon Rha, MD
        • Contact:
          • Seung-woon Rha, MD
      • Seoul, South Korea
        • Hallym University Hangang Sacred Heart Hospital
        • Contact:
          • Min-kyu Kim, MD
        • Principal Investigator:
          • Min-kyu Kim, MD
      • Ulsan, South Korea
        • Ulsan University Hospital
        • Contact:
          • Sang-gon Lee, MD
        • Principal Investigator:
          • Sang-gon Lee, MD
  • Taiwan
    • Taipei City
      • Taipei, Taipei City, Taiwan, 111013
        • Shin Kong Wu Ho-Su Memorial Hospital
        • Contact:
          • Jun-Jack Cheng, MD
        • Principal Investigator:
          • Jun-Jack Cheng, MD
  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
        • Contact:
          • Wasan Udayachalerm, MD
        • Principal Investigator:
          • Wasan Udayachalerm, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

  1. History of bleeding diathesis or coagulopathy
  2. Pregnant state
  3. Three vessel CTOs
  4. Known hypersensitivity or contra-indication 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 (ALT and AST) elevation ≥ 3 times normal
  10. Renal dysfunction, creatinine ≥ 2.0mg/dL
  11. Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent
  12. Left ventricular ejection fraction <30%
  13. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  14. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event rate of the composite event
Time Frame: 10 years
The composite of all cause death, myocardial infarction, stroke and any revascularization at minimum of 10 years follow-up.
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Event rate of all cause death
Time Frame: 10 years
10 years
Event rate of stroke
Time Frame: 10 years
10 years
Event rate of myocardial infarction
Time Frame: 10 years
10 years
Event rate of any revascularization
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seung-Jung Park

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV2025-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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