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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01350869
First received: April 22, 2011
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: Xience
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of Everolimus-Eluting Stents in Routine Clinical Practice

Resource links provided by NLM:


Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • Composite of death, nonfatal myocardial infarction (MI), and Target Vessel Revascularization (TVR) [ Time Frame: at 12 months after PCI ] [ Designated as safety issue: Yes ]
    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:
  • All Death [ Time Frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year ] [ Designated as safety issue: Yes ]
    1month ,6 month and 12 months,2year,3year,4 year and 5year

  • Cardiac death [ Time Frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year ] [ Designated as safety issue: Yes ]
    1month ,6 month and 12 months,2year,3year,4 year and 5year

  • MI [ Time Frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year ] [ Designated as safety issue: Yes ]
    1month ,6 month and 12 months,2year,3year,4 year and 5year

  • Composite of death or MI [ Time Frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year ] [ Designated as safety issue: Yes ]
    1month ,6 month and 12 months,2year,3year,4 year and 5year

  • Composite of cardiac death or MI [ Time Frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year ] [ Designated as safety issue: Yes ]
    1month ,6 month and 12 months,2year,3year,4 year and 5year

  • TVR [ Time Frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year ] [ Designated as safety issue: No ]
    1month ,6 month and 12 months,2year,3year,4 year and 5year

  • Target-lesion revascularization (TLR) [ Time Frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year ] [ Designated as safety issue: No ]
    1month ,6 month and 12 months,2year,3year,4 year and 5year

  • Stent thrombosis (ARC criteria) [ Time Frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year ] [ Designated as safety issue: Yes ]
    1month ,6 month and 12 months,2year,3year,4 year and 5year

  • Procedural success [ Time Frame: at discharge ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 3000
Study Start Date: June 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Xience stent
Real world patients treated with XIENCE stents
Device: Xience
Patients with 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350869

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

No publications provided

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
Study First Received: April 22, 2011
Last Updated: August 7, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on April 16, 2014