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

Seung-Jung Park

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01348360

CVRF2010-02

Details and patient eligibility

About

The objective of this study is to evaluate effectiveness and safety of Nobori 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 NOBORI stents versus first-generation DES in patients with coronary artery disease.

Enrollment: 2,000 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients receiving NOBORI 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

2,000 participants in 1 patient group

NOBORI stent