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Completed

NCT Number: NCT01350869

Evaluation of Everolimus-Eluting Stents (The K-XIENCE Registry)

The objective of this study is to evaluate effectiveness and safety of everolimus-eluting stents (XIENCE, Abbott) in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus-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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan medical center

Seoul, 138-739, South Korea

About this study

This study is a non-randomized, open-label registry to compare the efficacy and safety of everolimus-eluting stents versus sirolimus-eluting stents 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 received XIENCE 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

Xience

Device

Patients with Xience

Primary outcomes

  1. Composite of death, nonfatal myocardial infarction (MI), and Target Vessel Revascularization (TVR)

    Time frame: at 12 months after PCI

    composite of death, nonfatal myocardial infarction (MI), or ischemic driven Target Vessel Revascularization (TVR). Individual events are to be assessed as secondary.

Secondary outcomes

  1. All Death

    Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year

    1month ,6 month and 12 months,2year,3year,4 year and 5year

  2. Cardiac death

    Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year

    1month ,6 month and 12 months,2year,3year,4 year and 5year

  3. MI

    Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year

    1month ,6 month and 12 months,2year,3year,4 year and 5year

  4. Composite of death or MI

    Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year

    1month ,6 month and 12 months,2year,3year,4 year and 5year

  5. Composite of cardiac death or MI

    Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year

    1month ,6 month and 12 months,2year,3year,4 year and 5year

  6. TVR

    Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year

    1month ,6 month and 12 months,2year,3year,4 year and 5year

  7. Target-lesion revascularization (TLR)

    Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year

    1month ,6 month and 12 months,2year,3year,4 year and 5year

  8. Stent thrombosis (ARC criteria)

    Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year

    1month ,6 month and 12 months,2year,3year,4 year and 5year

  9. Procedural success

    Time frame: at discharge

    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

  • Abbott
  • CardioVascular Research Foundation, Korea

Registry information

Official study title

Evaluation of Effectiveness and Safety of Everolimus-Eluting Stents in Routine Clinical Practice

Important dates

Study start
2008
Primary completion
2011
Study completion
2014
First posted
May 10, 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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