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A Prospective Registry to Evaluate Renal Insufficiency of the Sirolimus-Eluting Coronary Stent (UltimasterTM tansei) in Patients with Coronary Artery Disease; A Multicenter, Prospective Observational Study

Not Applicable
Recruiting
Conditions
Diseases of the circulatory system
Registration Number
KCT0005337
Lead Sponsor
The Catholic University of Korea, St. Vincent's Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
1472
Inclusion Criteria

1) All patients over the age of 19 with coronary artery disease who receive the UltimasterTM tansei stent
2) patients or legal guardians voluntarily signing the consent form and agreeing with the study protocol and the schedule for clinical follow-up.

Exclusion Criteria

1) Patients treated with different drug stents at the time of research registration
2) Patients whose life expectancy are less than 1 year
3) Patients with cardiogenic shock or severe pulmonary edema

Study & Design

Study Type
Observational Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Combined clinical events which involve death, myocardial infarction(non-fatal) or target vessel revascularization (TVR) at 12 months after coronary intervention
Secondary Outcome Measures
NameTimeMethod
Each of the following events which involve the followings at 12 months after coronary intervention (1) All deaths (2) Cardiac death (3) Myocardial infarction (MI) (4) Composite of death and myocardial infarction (5) Composite of cardiac death and myocardial infarction (6) Composite of death, myocardial infarction, and target vessel revascularization (7) Composite of cardiac death, myocardial infarction, and target vessel revascularization (8) Composite of death, myocardial infarction, and target lesion revascularization (9) Composite of cardiac death, myocardial infarction, target lesion revascularization (10) Target vessel revascularization (TVR) (11) Target lesion revascularization (TLR) (12) Stent thrombosis (ARC standard) (13) Procedure success(Case where there was no death nor Q-wave myocardial infarction or urgent revascularization during hospitalization as less 30% of final residual stenosis in evaluation by angiography naked eye after procedure)
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