Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusio

Not Applicable

Terminated

Conditions: Diseases of the circulatory system

Registration Number: KCT0002918

Lead Sponsor: Asan Medical Center

Brief Summary: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups.

Detailed Description: Not available

Recruitment & Eligibility

Status: Terminated

Sex: All

Target Recruitment: 834

Inclusion Criteria

Clinical

Patients with angina or silent ischemia and documented ischemia
Patients who are eligible for intracoronary stenting
Age > 18 years
Angiographic

De novo lesion CTO
Reference vessel size 2.5 mm by visual estimation
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 flow 0 and 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 Criteria

History of bleeding diathesis or coagulopathy
Pregnant state
Three vessel CTO
Known hypersensitivity or contra-indication to contrast agent and heparin
ST-elevation acute myocardial infarction requiring primary stenting
Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels 4) Distal epicardial coronary artery CTO lesions
Hematological disease
Hepatic dysfunction, liver enzyme (ALT and AST) elevation 3 times normal
Renal dysfunction, creatinine more than 2.0
Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent
Left ventricular ejection fraction
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).

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization

Secondary Outcome Measures

Name	Time	Method
all death;Acute myocardial infarction;stroke;Revascularization;Revascularization due to chronic total occlusion;Hospitalization due to acute coronary syndome;left ventricular ejection fraction;Angina class;Quality of Life;Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization