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Orsiro™ Drug Eluting Stent in Routine Clinical Practice

Evaluation of Effectiveness and Safety of Orsiro™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02039739
Acronym
IRIS ORSIRO
Enrollment
1007
Registered
2014-01-20
Start date
2014-06-30
Completion date
2022-01-31
Last updated
2023-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioplasty, Transluminal, Percutaneous Coronary, Coronary Artery Disease

Keywords

Orsiro, Drug Eluting Stent, Routine Clinical Practice, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Artery Disease

Brief summary

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

Interventions

DEVICEOrsiro™ Drug Eluting Stent group

Sponsors

CardioVascular Research Foundation, Korea
CollaboratorOTHER
Biotronik Korea Co., Ltd
CollaboratorINDUSTRY
Seung-Jung Park
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Composite event rate1YEAR

Secondary

MeasureTime frameDescription
CARDIAC DEATH5YEAR—
MYOCARDIAL INFARCTION5YEAR—
Composite event of death or myocardial infarction5YEAR—
Composite event of cardiac death or myocardial infarction5YEAR—
ALL DEATH5YEAR—
Target Lesion revascularization5YEAR—
Stent thrombosis5YEARstent thrombosis as classified by an Academic Research Consortium
Stroke5YEAR—
Procedural success3daydefined 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.
Target Vessel revascularization5YEAR—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026