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

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: Coronary Artery Disease; Angioplasty, Transluminal, Percutaneous Coronary
• Intervention / Treatment: Device: Orsiro™ Drug Eluting Stent group

• Study Type: Observational
• Enrollment (Actual): 1007

Contacts and Locations

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

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	1YEAR

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Target Vessel revascularization		5YEAR
Target Lesion revascularization		5YEAR
Stent thrombosis	stent thrombosis as classified by an Academic Research Consortium	5YEAR
Stroke		5YEAR
Procedural success	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

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea; Biotronik Korea Co., Ltd

Study record dates

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: Coronary Artery Disease; Drug Eluting Stent; Routine Clinical Practice; Angioplasty, Transluminal, Percutaneous Coronary; Orsiro
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• 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