Evaluation of Effectiveness and Safety of the GENOUS STENT (IRIS-GENOUS STEMI)

Seung-Jung Park

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01348373

CVRF2010-05

Details and patient eligibility

About

The objective of this study is to evaluate effectiveness and safety of GENOUS EPC-coated stent in patients with STEMI with other drug-eluting stents (DESs).

Full description

This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of GENOUS stent in STEMI patients with other-type DESs.

Enrollment: 464 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• STEMI Patients requiring primary PCI.
• 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

464 participants in 1 patient group

GENOUS EPC-coated stent

Description:

Patients treated with GENOUS EPC-coated stent