Orsiro™ Drug Eluting Stent in Routine Clinical Practice

Completed

• Conditions: Angioplasty, Transluminal, Percutaneous Coronary; Coronary Artery Disease

• Registration Number: NCT02039739
• Lead Sponsor: Seung-Jung Park

Brief Summary

The purpose of this study is to evaluate effectiveness and safety of Orsiro™ Drug Eluting Stent in Routine Clinical Practice

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-20
• Study Start: 2014-06
• Primary Completion: 2017-08
• Study Completion: 2022-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1007

Inclusion Criteria

• Age 20 and more
• Intervention with Orsiro™ Drug Eluting Stent
• Agreed with written informed consent form

Exclusion Criteria

• Intervention with Orsiro™ drug eluting coronary stent and other drug eluting stent at the same time
• Life expectancy of 1year and under
• Cardiac shock

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite event rate	1YEAR

Secondary Outcome Measures

Name	Time	Method
CARDIAC DEATH	5YEAR
Target Vessel revascularization	5YEAR
Stroke	5YEAR
Composite event of cardiac death or myocardial infarction	5YEAR
ALL DEATH	5YEAR
MYOCARDIAL INFARCTION	5YEAR
Procedural success	3day	defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization; participants will be followed for the duration of hospital stay, an expected average of 3days.
Stent thrombosis	5YEAR	stent thrombosis as classified by an Academic Research Consortium
Composite event of death or myocardial infarction	5YEAR
Target Lesion revascularization	5YEAR

Trial Locations

Locations (18)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon, Korea, Republic of

Dankook University Hospital; 🇰🇷 Cheonan, Korea, Republic of

Soon Chun Hyang University Hospital Cheonan; 🇰🇷 Cheonan, Korea, Republic of

Gangwon National Univ. Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

The Catholic University of Korea, Daejeon ST. Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of

Gangneung Asan Hospital; 🇰🇷 Gangneung, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

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