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

This study is ongoing, but not recruiting participants.
CardioVascular Research Foundation, Korea
Boston Scientific Corporation
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea Identifier:
First received: April 22, 2011
Last updated: June 22, 2016
Last verified: June 2016
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.

Coronary Artery Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:

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

Secondary Outcome Measures:
  • Death (all-cause and cardiac) [ Time Frame: 30 days ]
  • Myocardial infarction [ Time Frame: 30 days ]
  • Composite of death or MI [ Time Frame: 30 days ]
  • Composite of cardiac death or MI [ Time Frame: 30 days ]
  • Target Vessel Revascularization [ Time Frame: 30 days ]
  • Target lesion revascularization [ Time Frame: 30 days ]
  • Stent thrombosis [ Time Frame: 30 days ]
  • 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.

  • Death (all cause and cardiac) [ Time Frame: 6 months ]
  • Death (all cause and cardiac) [ Time Frame: yearly up to 5 years ]
  • Myocardial infarction [ Time Frame: 6 months ]
  • Myocardial infarction [ Time Frame: yearly up to 5 years ]
  • Composite of death or MI [ Time Frame: 6 months ]
  • Composite of death or MI [ Time Frame: yearly up to 5 years ]
  • Composite of cardiac death or MI [ Time Frame: 6 months ]
  • Composite of cardiac death or MI [ Time Frame: yearly up to 5 years ]
  • Target Vessel Revascularization [ Time Frame: 6 months ]
  • Target Vessel Revascularization [ Time Frame: yearly up to 5 years ]
  • Target lesion revascularization [ Time Frame: 6 months ]
  • Target lesion revascularization [ Time Frame: yearly up to 5 years ]
  • Stent thrombosis [ Time Frame: 6 months ]
  • Stent thrombosis [ Time Frame: yearly up to 5 years ]

Enrollment: 3018
Study Start Date: May 2010
Estimated Study Completion Date: October 2017
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Promus Element stent
Patients receiving Promus Element stents

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.


Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01350791

Korea, Republic of
41 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
  More Information

Responsible Party: Seung-Jung Park, MD,PhD, CardioVascular Research Foundation, Korea Identifier: NCT01350791     History of Changes
Other Study ID Numbers: CVRF2010-04
Study First Received: April 22, 2011
Last Updated: June 22, 2016

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on May 25, 2017