Evaluation of Everolimus-Eluting Stents (The K-XIENCE Registry)
Evaluation of Effectiveness and Safety of Everolimus-Eluting Stents in Routine Clinical Practice
1 other identifier
observational
3,000
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 22, 2011
CompletedFirst Posted
Study publicly available on registry
May 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedNovember 11, 2015
November 1, 2015
3.5 years
April 22, 2011
November 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Composite of death, nonfatal myocardial infarction (MI), and Target Vessel Revascularization (TVR)
composite of death, nonfatal myocardial infarction (MI), or ischemic driven Target Vessel Revascularization (TVR). Individual events are to be assessed as secondary.
at 12 months after PCI
Secondary Outcomes (9)
All Death
1month ,6 month and 12 months,2year,3year,4 year and 5year
Cardiac death
1month ,6 month and 12 months,2year,3year,4 year and 5year
MI
1month ,6 month and 12 months,2year,3year,4 year and 5year
Composite of death or MI
1month ,6 month and 12 months,2year,3year,4 year and 5year
Composite of cardiac death or MI
1month ,6 month and 12 months,2year,3year,4 year and 5year
- +4 more secondary outcomes
Study Arms (1)
Xience stent
Real world patients treated with XIENCE stents
Interventions
Eligibility Criteria
The registry will be conducted at 33 centers in Korea. Data will be collected on approximately 3,000 subjects treated with XIENCE stents.
You may qualify if:
- 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.
You may not qualify if:
- Patients with a mixture of other DESs
- Terminal illness with life expectancy \<1 year.
- Patients with cardiogenic shock
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
- Abbottcollaborator
Study Sites (1)
Asan medical center
Seoul, Seoul, 138-739, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jung Park, MD, PhD
Asan Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
Study Record Dates
First Submitted
April 22, 2011
First Posted
May 10, 2011
Study Start
June 1, 2008
Primary Completion
December 1, 2011
Study Completion
June 1, 2014
Last Updated
November 11, 2015
Record last verified: 2015-11