Orsiro™ Drug Eluting Stent in Routine Clinical Practice (IRIS ORSIRO)

June 27, 2023 updated by: Seung-Jung Park

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1007

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of
        • Hallym University Sacred Heart Hospital
      • Bucheon, Korea, Republic of
        • Soon Chun Hyang University Hospital Bucheon
      • Cheonan, Korea, Republic of
        • Soon Chun Hyang University Hospital Cheonan
      • Cheonan, Korea, Republic of
        • Dankook University Hospital
      • Chuncheon, Korea, Republic of
        • Gangwon National Univ. Hospital
      • Daegu, Korea, Republic of
        • Daegu Catholic University Medical Center
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Daejeon, Korea, Republic of
        • The Catholic University of Korea, Daejeon St. Mary's Hospital
      • Gangneung, Korea, Republic of
        • Gangneung Asan Hospital
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Incheon, Korea, Republic of
        • Gachon University Gil Hospital
      • Pusan, Korea, Republic of
        • Inje University Pusan Paik Hospital
      • Pusan, Korea, Republic of
        • Pusan National University Yangsan Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of
        • Kangdong Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with Orsiro™ Drug Eluting Stent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Orsiro™ Drug Eluting Stent
Device: Orsiro™ Drug Eluting Stent group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite event rate
Time Frame: 1YEAR
1YEAR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ALL DEATH
Time Frame: 5YEAR
5YEAR
CARDIAC DEATH
Time Frame: 5YEAR
5YEAR
MYOCARDIAL INFARCTION
Time Frame: 5YEAR
5YEAR
Composite event of death or myocardial infarction
Time Frame: 5YEAR
5YEAR
Composite event of cardiac death or myocardial infarction
Time Frame: 5YEAR
5YEAR
Target Vessel revascularization
Time Frame: 5YEAR
5YEAR
Target Lesion revascularization
Time Frame: 5YEAR
5YEAR
Stent thrombosis
Time Frame: 5YEAR
stent thrombosis as classified by an Academic Research Consortium
5YEAR
Stroke
Time Frame: 5YEAR
5YEAR
Procedural success
Time Frame: 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.
3day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seung-Jung Park

Collaborators

CardioVascular Research Foundation, Korea
Biotronik Korea Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimated)

January 20, 2014

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV2014-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is not a publicly funded trial.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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