An observational study to evaluate the effectiveness and safety of sirolimus-eluting stents in patients at high risk of cardiovascular disease

Not Applicable

Conditions: Diseases of the circulatory system

Registration Number: KCT0005639

Lead Sponsor: Keimyung University Dongsan Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 1500

Inclusion Criteria

* Patients with one of the following conditions among coronary artery disease requiring sirolimus-eluting coronary stent (UltimasterTM TanseiTM) treatment
? Complex coronary artery disease
-multi-vessel disease-left main disease-severe calcified lesion
-chronic total occlusion lesion-bifurcation lesion
-diffuse long lesion-small vessel lesion-ostial lesion
-thrombus containing lesion-in-stent restenosis lesion
-vein graft lesion
? Patient comorbidities
-advanced age (=80 years old)-acute coronary syndrome
-diabetes-chronic kidney disease (creatinine >1.5 mg/dL)
-heart failure (NYHA GIII-IV)
-depressed left ventricular function (ejection fraction <50%)
-prior cardiac surgery-cardiogenic shock
* Patients who have agreed on the study plan and clinical follow-up schedule, and have previously agreed in writing as approved by the research review committee/ethics committee of each clinical research institution

Exclusion Criteria

* When administration of the following drugs is prohibited: aspirin, heparin, clopidogrel, control substance or sirolimus
* During the first 6 months post-registration period, pending surgery that requires intervention with antiplatelet drugs is planned.
* Women who are lactating, pregnant or wishing to become pregnant
* Terminal disease with a lifespan of less than 1 year

Study & Design

Study Type: Observational Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target lesion treatment failure

Secondary Outcome Measures

Name	Time	Method
Target lesion treatment failure;Target vessel treatment failure;All Death;Cardiac death;All Death and Myocardial infarction;Cardiac Death and Myocardial infarction;Ischemia-driven Target lesion retreatment;Ischemia-driven Target vessel retreatment;Stent Thrombosis;Bleeding