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

Seung-Jung Park

Status: Begins enrollment in 1 month

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT06908499

AMCCV2025-01

Details and patient eligibility

About

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.

Enrollment: 840 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

840 participants in 1 patient group

Patients with chronic total occlusion

Description:

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