Evaluation of Effectiveness and Safety of PROMUS Element Stent (IRIS-ELEMENT )

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. Identifier: NCT01350791
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : July 21, 2017
CardioVascular Research Foundation, Korea
Boston Scientific Corporation
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Brief Summary:
This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of Promus Element stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease.

Condition or disease
Coronary Artery Disease

Detailed Description:

The Element Stent platform features a proprietary Platinum Chromium Alloy, designed specifically for coronary stents. This alloy, coupled with a new stent architecture, is designed to enable thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility. In addition, the PROMUS Element Stent System incorporates the new Apex™ Dilatation Catheter technology, designed to enhance deliverability to complex lesions.

Currently, there have been limited data regarding comparison of PROMUS Element stent with first-generation DES in routine clinical practice. Therefore, we perform large-scale real-world registry of PROMUS Element stents.

Study Type : Observational
Actual Enrollment : 3001 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of PROMUS Element™ in Routine Clinical Practice; A Multicenter, PROSPECTIVE OBSERVATIONAL STUDY
Actual Study Start Date : May 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Promus Element stent
Patients receiving Promus Element stents

Primary Outcome Measures :
  1. Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) [ Time Frame: 12 months post stenting procedure ]

Secondary Outcome Measures :
  1. Death (all-cause and cardiac) [ Time Frame: 30 days ]
  2. Myocardial infarction [ Time Frame: 30 days ]
  3. Composite of death or MI [ Time Frame: 30 days ]
  4. Composite of cardiac death or MI [ Time Frame: 30 days ]
  5. Target Vessel Revascularization [ Time Frame: 30 days ]
  6. Target lesion revascularization [ Time Frame: 30 days ]
  7. Stent thrombosis [ Time Frame: 30 days ]
  8. Procedural success(defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization) [ Time Frame: 3 days in average ]
    At discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days.

  9. Death (all cause and cardiac) [ Time Frame: 6 months ]
  10. Death (all cause and cardiac) [ Time Frame: yearly up to 5 years ]
  11. Myocardial infarction [ Time Frame: 6 months ]
  12. Myocardial infarction [ Time Frame: yearly up to 5 years ]
  13. Composite of death or MI [ Time Frame: 6 months ]
  14. Composite of death or MI [ Time Frame: yearly up to 5 years ]
  15. Composite of cardiac death or MI [ Time Frame: 6 months ]
  16. Composite of cardiac death or MI [ Time Frame: yearly up to 5 years ]
  17. Target Vessel Revascularization [ Time Frame: 6 months ]
  18. Target Vessel Revascularization [ Time Frame: yearly up to 5 years ]
  19. Target lesion revascularization [ Time Frame: 6 months ]
  20. Target lesion revascularization [ Time Frame: yearly up to 5 years ]
  21. Stent thrombosis [ Time Frame: 6 months ]
  22. Stent thrombosis [ Time Frame: yearly up to 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Coronary artery disease requiring drug eluting stents

Inclusion Criteria:

  • Patients receiving Promus Element stents
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

  • Patients with a mixture of other DESs
  • Terminal illness with life expectancy <1 year
  • Patients with cardiogenic 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 identifier (NCT number): NCT01350791

Korea, Republic of
38 Centers
Seoul, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Boston Scientific Corporation
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
Principal Investigator: Ki Bae Seung, MD, PhD Seoul St. Mary's Hospital, Catholic University of Korea

Responsible Party: Seung-Jung Park, MD,PhD, CardioVascular Research Foundation, Korea Identifier: NCT01350791     History of Changes
Other Study ID Numbers: CVRF2010-04
First Posted: May 10, 2011    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases