Orsiro™ Drug Eluting Stent in Routine Clinical Practice
IRIS ORSIRO
Evaluation of Effectiveness and Safety of Orsiro™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study
1 other identifier
observational
1,007
1 country
18
Brief Summary
The purpose of this study is to evaluate effectiveness and safety of Orsiro™ Drug Eluting Stent in Routine Clinical Practice
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2014
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2014
CompletedFirst Posted
Study publicly available on registry
January 20, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedJune 28, 2023
June 1, 2023
3.2 years
January 16, 2014
June 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite event rate
1YEAR
Secondary Outcomes (10)
ALL DEATH
5YEAR
CARDIAC DEATH
5YEAR
MYOCARDIAL INFARCTION
5YEAR
Composite event of death or myocardial infarction
5YEAR
Composite event of cardiac death or myocardial infarction
5YEAR
- +5 more secondary outcomes
Study Arms (1)
Orsiro™ Drug Eluting Stent
Interventions
Eligibility Criteria
patients with Orsiro™ Drug Eluting Stent
You may qualify if:
- Age 20 and more
- Intervention with Orsiro™ Drug Eluting Stent
- Agreed with written informed consent form
You may not qualify if:
- Intervention with Orsiro™ drug eluting coronary stent and other drug eluting stent at the same time
- Life expectancy of 1year and under
- Cardiac shock
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
- Biotronik Korea Co., Ltdcollaborator
Study Sites (18)
Hallym University Sacred Heart Hospital
Anyang, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Dankook University Hospital
Cheonan, South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
Gangwon National Univ. Hospital
Chuncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Gachon University Gil Hospital
Incheon, South Korea
Inje University Pusan Paik Hospital
Pusan, South Korea
Pusan National University Yangsan Hospital
Pusan, South Korea
Asan Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Kangdong Sacred Heart Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD,PhD
Study Record Dates
First Submitted
January 16, 2014
First Posted
January 20, 2014
Study Start
June 1, 2014
Primary Completion
August 1, 2017
Study Completion
January 1, 2022
Last Updated
June 28, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share
This is not a publicly funded trial.