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IRIS-PREMIER REGISTRY (IRIS-PREMIER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02060968
Recruitment Status : Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : June 18, 2020
Sponsor:
Collaborators:
CardioVascular Research Foundation, Korea
Boston Scientific Korea Co. Ltd
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

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
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Device: Promus PREMIER

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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 : August 2014
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : June 2021

Group/Cohort Intervention/treatment
IRIS PREMIER Cohort
Promus PREMIER
Device: Promus PREMIER



Primary Outcome Measures :
  1. Composite event rate [ Time Frame: 1year ]
    Death, non fatal myocardial infarction, Target Vessel Revascularization


Secondary Outcome Measures :
  1. All death [ Time Frame: 5year ]
  2. Cardiac death [ Time Frame: 5year ]
  3. Myocardial infarction [ Time Frame: 5year ]
  4. Composite event of death or myocardial infarction [ Time Frame: 5year ]
  5. Composite event of cardiac death or myocardial infarction [ Time Frame: 5year ]
  6. Target Vessel revascularization [ Time Frame: 5year ]
  7. Target lesion revascularization [ Time Frame: 5year ]
  8. Stent thrombosis by an Academic Research Consortium (ARC) criteria [ Time Frame: 5year ]
  9. procedural success [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with Promus PREMIER stent
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060968


Locations
Show Show 25 study locations
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Boston Scientific Korea Co. Ltd
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Responsible Party: Seung-Jung Park, MD,PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02060968    
Other Study ID Numbers: AMCCV2014-03
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not a publicly funded trial.
Keywords provided by Seung-Jung Park, Asan Medical Center:
Promus PREMIER
Routine Clinical Practice
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes