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Clinical Trials in India / NCT06908499
Recruiting Observational

The DECISION-CTO Extended 10 Y Follow-up

NCT06908499 · tracked via the Priya Life Science India tracker
Sponsor
Seung-Jung Park
Phase
Observational
Started
2026-04-01
Last updated
2026-06-24

Condition(s) studied

Coronary Artery Disease

Study summary

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (19)

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

More Seung-Jung Park trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06908499 on ClinicalTrials.gov ↗ ← All trials in India