IRIS ORSIRO: Orsiro™ Drug Eluting Stent in Routine Clinical Practice

Sponsor

Seung-Jung Park (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02039739

Collaborator

CardioVascular Research Foundation, Korea (Other), Biotronik Korea Co., Ltd (Industry)

1,007

Enrollment

Locations

Anticipated Duration (Months)

55.9

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Angioplasty, Transluminal, Percutaneous Coronary Coronary Artery Disease	Device: Orsiro™ Drug Eluting Stent group

Study Design

Study Type:

Observational

Actual Enrollment :

1007 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Aug 1, 2017

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Orsiro™ Drug Eluting Stent	Device: Orsiro™ Drug Eluting Stent group

Arm

Intervention/Treatment

Orsiro™ Drug Eluting Stent

Device: Orsiro™ Drug Eluting Stent group

Outcome Measures

Primary Outcome Measures

Composite event rate [1YEAR]

Secondary Outcome Measures

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 [5YEAR]
stent thrombosis as classified by an Academic Research Consortium
Stroke [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Hallym University Sacred Heart Hospital	Anyang	Korea, Republic of
2	Soon Chun Hyang University Hospital Bucheon	Bucheon	Korea, Republic of
3	Dankook University Hospital	Cheonan	Korea, Republic of
4	Soon Chun Hyang University Hospital Cheonan	Cheonan	Korea, Republic of
5	Gangwon National Univ. Hospital	Chuncheon	Korea, Republic of
6	Daegu Catholic University Medical Center	Daegu	Korea, Republic of
7	Keimyung University Dongsan Medical Center	Daegu	Korea, Republic of
8	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon	Korea, Republic of
9	Gangneung Asan Hospital	Gangneung	Korea, Republic of
10	Chonnam National University Hospital	Gwangju	Korea, Republic of
11	Gachon University Gil Hospital	Incheon	Korea, Republic of
12	Inje University Pusan Paik Hospital	Pusan	Korea, Republic of
13	Pusan National University Yangsan Hospital	Pusan	Korea, Republic of
14	Asan Medical Center	Seoul	Korea, Republic of
15	Gangnam Severance Hospital	Seoul	Korea, Republic of
16	Kangdong Sacred Heart Hospital	Seoul	Korea, Republic of
17	Korea University Guro Hospital	Seoul	Korea, Republic of
18	Ulsan University Hospital	Ulsan	Korea, Republic of