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

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ClinicalTrials.gov Identifier: NCT01350869
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : November 11, 2015
Sponsor:
Collaborators:
CardioVascular Research Foundation, Korea
Abbott
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Brief Summary:
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).

Condition or disease Intervention/treatment
Coronary Artery Disease Device: Xience

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of Everolimus-Eluting Stents in Routine Clinical Practice
Study Start Date : June 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus
U.S. FDA Resources

Group/Cohort Intervention/treatment
Xience stent
Real world patients treated with XIENCE stents
Device: Xience
Patients with Xience



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The registry will be conducted at 33 centers in Korea. Data will be collected on approximately 3,000 subjects treated with XIENCE stents.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350869


Locations
Korea, Republic of
Asan medical center
Seoul, Korea, Republic of, 138-739
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Abbott
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01350869     History of Changes
Other Study ID Numbers: 2009-0588
First Posted: May 10, 2011    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs