NCT02060968

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,006

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

February 10, 2014

Last Update Submit

September 6, 2021

Conditions

Keywords

Promus PREMIERRoutine Clinical Practice

Outcome Measures

Primary Outcomes (1)

  • Composite event rate

    Death, non fatal myocardial infarction, Target Vessel Revascularization

    1year

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (1)

IRIS PREMIER Cohort

Promus PREMIER

Device: Promus PREMIER

Interventions

IRIS PREMIER Cohort

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with Promus PREMIER stent

You may qualify if:

  • Age 20 and more
  • Intervention with Promus PREMIER everolimus eluting coronary stent
  • Agreed with written informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Gangwon National Univ. Hospital

Chuncheon, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

The Catholic University of Korea, Daejeon ST. Mary's Hospital

Daejeon, South Korea

Location

Gangneung Asan Hospital

Gangneung, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

Kwangju Christian Hospital

Kwangju, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

Kosin University Hospital

Pusan, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Asan Medical Hospital

Seoul, South Korea

Location

Eulji General Hospital

Seoul, South Korea

Location

Kangdong Sacred Heart Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyunghee University Medical Center

Seoul, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

Location

The Catholic University of Korea St. Paul's Hospital

Seoul, South Korea

Location

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaCoronary DiseaseHeart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 12, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2021

Last Updated

September 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

This is not a publicly funded trial.

Locations