Evaluation of Effectiveness and Safety of BIOMATRIX Stent (IRIS-BIOMATRIX)

Seung-Jung Park

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01350778

CVRF2010-03

Details and patient eligibility

About

The objective of this study is to evaluate effectiveness and safety of BioMatrix stent in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus- or paclitaxel-eluting stents).

Full description

This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of BioMatrix stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease.

Enrollment: 837 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients receiving BioMatrix 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

837 participants in 1 patient group

Biomatrix stent

Description:

patients treated with Biomatrix stent