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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350869
• Other study ID #: 2009-0588
• Status: Completed
• Phase: Phase 4
• First received: April 22, 2011
• Last updated: November 10, 2015
• Start date: June 2008
• Est. completion date: June 2014

Study information

• Verified date: November 2015
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: June 2014
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Xience
Patients with Xience

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seung-Jung Park	Abbott, CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	Procedural success	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	at discharge	No