Evaluation of Effectiveness and Safety of XIENCE PRIME Stent (IRIS-PRIME)

Seung-Jung Park

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01348399

CVRF2011-01

Details and patient eligibility

About

The objective of this study is to evaluate effectiveness and safety of XIENCE PRIME stent in the "real world" daily practice as compared with other drug eluting stents (DESs)

Full description

This study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of XIENCE PRIME stents versus other DESs in patients with coronary artery disease.

Enrollment: 2,000 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients receiving XIENCE PRIME 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 presented with cardiogenic shock

Trial design

2,000 participants in 1 patient group

XIENCE PRIME stents