Status:
NOT_YET_RECRUITING
The DECISION-CTO Extended 10 Y Follow-up
Lead Sponsor:
Seung-Jung Park
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
19+ years
Brief 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 fol...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT06908499
Start Date
April 1 2026
End Date
May 31 2026
Last Update
December 29 2025
Active Locations (19)
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1
Ruby Hall Clinic
Pune, Maharashtra, India, 411001
2
Medistra Hospital
Jakarta, DKI Jakarta, Indonesia, 12950
3
SAM hospital
Anyang, South Korea
4
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea