The DECISION-CTO Extended 10 Y Follow-up

Recruiting now

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT06908499

Run by

Seung-Jung Park

People needed

840

Starts

2026-04-01

Expected to finish

2026-12-31

Last updated by the study team

2026-06-24

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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