Evaluation of Everolimus-Eluting Stents (The K-XIENCE Registry)
This study is ongoing, but not recruiting participants.
Sponsor:
Seung-Jung Park
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
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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 May 23, 2013