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Completed

NCT Number: NCT01348373

Evaluation of Effectiveness and Safety of the GENOUS STENT (IRIS-GENOUS STEMI)

The objective of this study is to evaluate effectiveness and safety of GENOUS EPC-coated stent in patients with STEMI with other drug-eluting stents (DESs).

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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

Soon Chun Hyang University Hospital Bucheon, Bucheon-si, South Korea

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About this study

This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of GENOUS stent in STEMI patients with other-type DESs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • STEMI Patients requiring primary PCI.
  • 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 procedure

Secondary outcomes

  1. Death (all cause and cardiac)

    Time frame: one month

  2. Death (all cause and cardiac)

    Time frame: 6 months

  3. Death (all cause and cardiac)

    Time frame: yearly up to 5 years

  4. MI

    Time frame: one month

  5. MI

    Time frame: 6 months

  6. MI

    Time frame: yearly up to 5 years

  7. Composite of death or MI

    Time frame: one month

  8. Composite of death or MI

    Time frame: 6 months

  9. Composite of death or MI

    Time frame: yearly up to 5 years

  10. Composite of cardiac death or MI

    Time frame: one month

  11. Composite of cardiac death or MI

    Time frame: 6 months

  12. Composite of cardiac death or MI

    Time frame: yearly up to 5 years

  13. TVR

    Time frame: one month

  14. TVR

    Time frame: 6 months

  15. TVR

    Time frame: yearly up to 5 years

  16. Target-lesion revascularization (TLR)

    Time frame: yearly up to 5 years

  17. Target-lesion revascularization (TLR)

    Time frame: one month

  18. Target-lesion revascularization (TLR)

    Time frame: 6 months

  19. Stent thrombosis (ARC criteria)

    Time frame: one month

  20. Stent thrombosis (ARC criteria)

    Time frame: 6 months

  21. Stent thrombosis (ARC criteria)

    Time frame: yearly up to 5 years

  22. 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: in-hospital

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea
  • OrbusNeich Medical Korea Co., Ltd.

Registry information

Official study title

Evaluation of Effectiveness and Safety of the GENOUS STENT in ST-Segment Elevation Myocardial Infarction

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 5, 2011
Registry last updated
Nov 11, 2015

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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