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

Seung-Jung Park

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Xience

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01350869

2009-0588

Details and patient eligibility

About

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).

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

3,000 participants in 1 patient group

Xience stent

Description:

Real world patients treated with XIENCE stents

Treatment:

Device: Xience