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Completed

NCT Number: NCT01350778

Evaluation of Effectiveness and Safety of BIOMATRIX Stent (IRIS-BIOMATRIX)

The objective of this study is to evaluate effectiveness and safety of BioMatrix stent in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus- or paclitaxel-eluting stents).

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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 Cheonan, Cheonan, 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 BioMatrix stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients receiving BioMatrix 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 procedure

Secondary outcomes

  1. All Death

    Time frame: one month

  2. All Death

    Time frame: 6 months

  3. All Death

    Time frame: yearly upto 5 years

  4. Cardiac death

    Time frame: one month

  5. Cardiac death

    Time frame: 6 months

  6. Cardiac death

    Time frame: yearly upto 5 years

  7. MI

    Time frame: one month

  8. MI

    Time frame: 6 months

  9. MI

    Time frame: yearly upto 5 years

  10. Composite of death or MI

    Time frame: one month

  11. Composite of death or MI

    Time frame: 6 months

  12. Composite of death or MI

    Time frame: yearly upto 5 years

  13. Composite of cardiac death or MI

    Time frame: one month

  14. Composite of cardiac death or MI

    Time frame: 6 months

  15. Composite of cardiac death or MI

    Time frame: yearly upto 5 years

  16. TVR

    Time frame: one month

  17. TVR

    Time frame: 6 months

  18. TVR

    Time frame: yearly upto 5 years

  19. Target-lesion revascularization (TLR)

    Time frame: one month

  20. Target-lesion revascularization (TLR)

    Time frame: 6 months

  21. Target-lesion revascularization (TLR)

    Time frame: yearly upto 5 years

  22. Stent thrombosis (ARC criteria)

    Time frame: one month

  23. Stent thrombosis (ARC criteria)

    Time frame: 6 months

  24. Stent thrombosis (ARC criteria)

    Time frame: yearly upto 5 years

  25. 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.

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea
  • Dio

Registry information

Official study title

Evaluation of Effectiveness and Safety of BIOMATRIX in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Important dates

Study start
2010
Primary completion
2016
Study completion
2020
First posted
May 10, 2011
Registry last updated
Jan 27, 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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