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

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Xience

• Registration Number: NCT01350869
• Lead Sponsor: Seung-Jung Park

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).

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2011-04-22
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Primary Completion: 2011-12
• Study Completion: 2014-06
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-10
• Last Update Posted: 2015-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Xience stent	Xience	Real world patients treated with XIENCE stents

Primary Outcome Measures

Name	Time	Method
Composite of death, nonfatal myocardial infarction (MI), and Target Vessel Revascularization (TVR)	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

Name	Time	Method
All Death	1month ,6 month and 12 months,2year,3year,4 year and 5year	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	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	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	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	1month ,6 month and 12 months,2year,3year,4 year and 5year
TVR	1month ,6 month and 12 months,2year,3year,4 year and 5year	1month ,6 month and 12 months,2year,3year,4 year and 5year
Target-lesion revascularization (TLR)	1month ,6 month and 12 months,2year,3year,4 year and 5year	1month ,6 month and 12 months,2year,3year,4 year and 5year
Stent thrombosis (ARC criteria)	1month ,6 month and 12 months,2year,3year,4 year and 5year	1month ,6 month and 12 months,2year,3year,4 year and 5year
Procedural success	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

Trial Locations

Locations (1)

Asan medical center; 🇰🇷 Seoul, Korea, Republic of