IRIS-PREMIER REGISTRY

• Sponsor: Seung-Jung Park (Other)
• Overall Status: Completed
• CT.gov ID: NCT02060968
• Collaborator: CardioVascular Research Foundation, Korea (Other), Boston Scientific Korea Co. Ltd (Industry)
• Enrollment: 2,006
• Locations: 25
• Actual Duration (Months): 82
• Patients Per Site: 80.2
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate effectiveness and safety of Promus PREMIER in Routine Clinical Practice

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases	Device: Promus PREMIER

Study Design

• Study Type: Observational
• Actual Enrollment: 2006 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Effectiveness and Safety of Promus PREMIER in Routine Clinical Practice; A Multicenter, Phase-IV, Prospective Observational Study
• Actual Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
IRIS PREMIER Cohort Promus PREMIER	Device: Promus PREMIER

Outcome Measures

Primary Outcome Measures

1. Composite event rate [1year]

   Death, non fatal myocardial infarction, Target Vessel Revascularization

Secondary Outcome Measures

1. All death [5year]

2. Cardiac death [5year]

3. Myocardial infarction [5year]

4. Composite event of death or myocardial infarction [5year]

5. Composite event of cardiac death or myocardial infarction [5year]

6. Target Vessel revascularization [5year]

7. Target lesion revascularization [5year]

8. Stent thrombosis by an Academic Research Consortium (ARC) criteria [5year]

9. Stroke [5year]

10. 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: No

Inclusion Criteria:

• Age 20 and more

• Intervention with Promus PREMIER everolimus eluting coronary stent

• Agreed with written informed consent form

Exclusion Criteria:

• Intervention with Promus PREMIER everolimus 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	State	Country	Postal Code
1	Hallym University Sacred Heart Hospital	Anyang		Korea, Republic of
2	Soon Chun Hyang University Hospital Cheonan	Cheonan		Korea, Republic of
3	Chungbuk National University Hospital	Cheongju		Korea, Republic of
4	Gangwon National Univ. Hospital	Chuncheon		Korea, Republic of
5	Daegu Catholic University Medical Center	Daegu		Korea, Republic of
6	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
7	Yeungnam University Medical Center	Daegu		Korea, Republic of
8	Chungnam National University Hospital	Daejeon		Korea, Republic of
9	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon		Korea, Republic of
10	Gangneung Asan Hospital	Gangneung		Korea, Republic of
11	Gachon University Gil Hospital	Incheon		Korea, Republic of
12	Kwangju Christian Hospital	Kwangju		Korea, Republic of
13	Inje University Pusan Paik Hospital	Pusan		Korea, Republic of
14	Kosin University Hospital	Pusan		Korea, Republic of
15	Pusan National University Hospital	Pusan		Korea, Republic of
16	Asan Medical Hospital	Seoul		Korea, Republic of
17	Eulji General Hospital	Seoul		Korea, Republic of
18	Kangdong Sacred Heart Hospital	Seoul		Korea, Republic of
19	Korea University Guro Hospital	Seoul		Korea, Republic of
20	Kyunghee University Medical Center	Seoul		Korea, Republic of
21	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul		Korea, Republic of
22	The Catholic University of Korea St. Paul's Hospital	Seoul		Korea, Republic of
23	The Catholic University of Korea Uijeongbu St. Mary's Hospital	Uijeongbu		Korea, Republic of
24	Ulsan University Hospital	Ulsan		Korea, Republic of
25	Pusan National University Yangsan Hospital	Yangsan		Korea, Republic of

Sponsors and Collaborators

• Seung-Jung Park
• CardioVascular Research Foundation, Korea
• Boston Scientific Korea Co. Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seung-Jung Park, MD,PhD, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT02060968
• Other Study ID Numbers: AMCCV2014-03
• First Posted: Feb 12, 2014
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Seung-Jung Park, MD,PhD, Asan Medical Center: Promus PREMIER; Routine Clinical Practice
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Ischemia

Study Results

No Results Posted as of Sep 13, 2021