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

Evaluation of Effectiveness and Safety of Everolimus-Eluting Stents in Routine Clinical Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01350869

Enrollment

3000

Registered

2011-05-10

Start date

2008-06-30

Completion date

2014-06-30

Last updated

2015-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DEVICEXience

Patients with Xience

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
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
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026