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OpenTrials
Completed

NCT Number: NCT01350791

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

38 Centers

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)

    Time frame: 12 months post stenting procedure

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • Boston Scientific Corporation
  • CardioVascular Research Foundation, Korea

Registry information

Official study title

Evaluation of Effectiveness and Safety of PROMUS Element™ in Routine Clinical Practice; A Multicenter, PROSPECTIVE OBSERVATIONAL STUDY

Important dates

Study start
2010
Primary completion
2013
Study completion
2016
First posted
May 10, 2011
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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