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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
History of Changes

April 22, 2011
August 7, 2012
June 2008
December 2011   (final data collection date for primary outcome measure)
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.
Composite of death, nonfatal myocardial infarction (MI), and Target Vessel Revascularization (TVR) [ Time Frame: 12 months post procedure ] [ 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.
Complete list of historical versions of study NCT01350869 on ClinicalTrials.gov Archive Site
  • 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
  • All Death [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • All Death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • All Death [ Time Frame: yearly upto 5 years ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: yearly upto 5 years ] [ Designated as safety issue: Yes ]
  • MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • MI [ Time Frame: yearly upto 5 years ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: yearly upto 5 years ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: yearly upto 5 years ] [ Designated as safety issue: Yes ]
  • TVR [ Time Frame: one month ] [ Designated as safety issue: No ]
  • TVR [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • TVR [ Time Frame: yearly upto 5 years ] [ Designated as safety issue: No ]
  • Target-lesion revascularization (TLR) [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Target-lesion revascularization (TLR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Target-lesion revascularization (TLR) [ Time Frame: yearly upto 5 years ] [ Designated as safety issue: No ]
  • Stent thrombosis (ARC criteria) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (ARC criteria) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (ARC criteria) [ Time Frame: yearly upto 5 years ] [ Designated as safety issue: Yes ]
  • 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
Not Provided
Not Provided
 
Evaluation of Everolimus-Eluting Stents (The K-XIENCE Registry)
Evaluation of Effectiveness and Safety of Everolimus-Eluting Stents in Routine Clinical Practice

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).

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

The registry will be conducted at 33 centers in Korea. Data will be collected on approximately 3,000 subjects treated with XIENCE stents.
Coronary Artery Disease
Device: Xience
Patients with Xience
Xience stent
Real world patients treated with XIENCE stents
Intervention: Device: Xience
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
December 2014
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01350869
2009-0588
Yes
Seung-Jung Park, CardioVascular Research Foundation, Korea
Seung-Jung Park
CardioVascular Research Foundation, Korea
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
CardioVascular Research Foundation, Korea
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP