Clinical trial NCT06908499: The DECISION-CTO Extended 10 Y Follow-up
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Artery Disease
Keywords: Chronic Total Occlusion
Drug-eluting Stent Implantation
Optimal Medical Treatment
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 840
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic total occlusion who were enrolled in the original DECISION-CTO trial (NCT01078051)

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 follow-up (minimum 10 years) period.


Eligibility criteria: 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 outcomes:
measure: Event rate of the composite event
timeFrame: 10 years
Secondary outcomes:
measure: Event rate of all cause death
timeFrame: 10 years
measure: Event rate of myocardial infarction
timeFrame: 10 years
measure: Event rate of stroke
timeFrame: 10 years
measure: Event rate of any revascularization
timeFrame: 10 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: