IRIS-PREMIER REGISTRY (IRIS-PREMIER)

Evaluation of Effectiveness and Safety of Promus PREMIER in Routine Clinical Practice; A Multicenter, Phase-IV, Prospective Observational Study

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

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Heart Diseases; Coronary Artery Disease; Coronary Disease
• Intervention / Treatment: Device: Promus PREMIER

• Study Type: Observational
• Enrollment (Actual): 2006

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Cheonan, Korea, Republic of
    • Soon Chun Hyang University Hospital Cheonan
  • Cheongju, Korea, Republic of
    • Chungbuk National 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
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Daejeon, Korea, Republic of
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Gangneung, Korea, Republic of
    • Gangneung Asan Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital
  • Kwangju, Korea, Republic of
    • Kwangju Christian Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Pusan, Korea, Republic of
    • Inje University Pusan Paik Hospital
  • Pusan, Korea, Republic of
    • Kosin University Hospital
  • Seoul, Korea, Republic of
    • Kyunghee University Medical Center
  • Seoul, Korea, Republic of
    • The Catholic University of Korea Seoul St. Mary'S Hospital
  • Seoul, Korea, Republic of
    • Eulji General Hospital
  • Seoul, Korea, Republic of
    • Kangdong Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea St. Paul's Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Hospital
  • Uijeongbu, Korea, Republic of
    • The Catholic University of Korea Uijeongbu St. Mary's Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
  • Yangsan, Korea, Republic of
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with Promus PREMIER stent

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IRIS PREMIER Cohort; Promus PREMIER	Device: Promus PREMIER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite event rate	Death, non fatal myocardial infarction, Target Vessel Revascularization	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 by an Academic Research Consortium (ARC) criteria		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: Boston Scientific Korea Co. Ltd; CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: February 10, 2014
• First Submitted That Met QC Criteria: February 10, 2014
• First Posted (Estimate): February 12, 2014

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Routine Clinical Practice; Promus PREMIER
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
• Other Study ID Numbers: AMCCV2014-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not a publicly funded trial.