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Completed

NCT Number: NCT01392846

The IRIS-Resolute Integrity (IRIS-Integrity)

This is a prospective, observational, cohort study to evaluate the relative efficacy and safety of Resolute Integrity stent compared to other (drug eluting stents) DES.

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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

Inje University Ilsan Paik Hospital, Ilsan, Gyeonggi-do, South Korea

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About this study

Consecutive Percutaneous Coronary Intervention patients receiving Resolute Integrity stent will be compared with other concurrent Drug Eluting Stents.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with significant coronary artery disease and receiving Resolute Integrity stent.
  • 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 presented with cardiogenic shock

Treatment and study plan

Primary outcomes

  1. composite of death, nonfatal myocardial infarction (MI), or 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: 12 months and yearly up to 5 years

  4. Myocardial Infarction

    Time frame: one month

  5. Myocardial Infarction

    Time frame: 6 months

  6. Myocardial Infarction

    Time frame: 12 months and yearly upto 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: 12 months and yearly upto 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: 12 months and yearly up to 5 years

  13. Target Vessel Revascularization

    Time frame: one month

  14. Target Vessel Revascularization

    Time frame: 6 months

  15. Target Vessel Revascularization

    Time frame: 12 months and yearly up to 5 years

  16. Target-lesion revascularization

    Time frame: one month

  17. Target-lesion revascularization

    Time frame: 6 months

  18. Target-lesion revascularization

    Time frame: 12 months and yearly up to 5 years

  19. Stent thrombosis

    Time frame: one month

  20. Stent thrombosis

    Time frame: 6 months

  21. Stent thrombosis

    Time frame: 12 months and yearly up to 5 years

  22. Stroke

    Time frame: 12 months and yearly up to 5 years

  23. Procedural success

    Time frame: at day 1

    It is 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.

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea
  • Medtronic

Registry information

Official study title

Evaluation of Effectiveness and Safety of Resolute Integrity DES in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-Integrity)

Important dates

Study start
2011
Primary completion
2016
Study completion
2020
First posted
Jul 13, 2011
Registry last updated
Sep 13, 2021

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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