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Recruiting NCT06908499

The DECISION-CTO Extended 10 Y Follow-up

— Observational Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India, Indonesia, South Korea, Taiwan, Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Event rate of the composite event [Time frame: 10 years]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

South Korea · 15 centers
  • 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
  • … and 7 more centers
India · 1 center
  • Ruby Hall Clinic — Pune
Indonesia · 1 center
  • Medistra Hospital — Jakarta
Taiwan · 1 center
  • Shin Kong Wu Ho-Su Memorial Hospital — Taipei
Thailand · 1 center
  • King Chulalongkorn Memorial Hospital — Bangkok

Identifiers

NCT: NCT06908499 · AMCCV2025-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗