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

Evaluation of Effectiveness and Safety of the GENOUS STENT in ST-Segment Elevation Myocardial Infarction

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01348373

Enrollment

464

Registered

2011-05-05

Start date

2010-05-31

Completion date

2014-06-30

Last updated

2015-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

drug eluting stents

Brief summary

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).

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)	12 months post procedure

Secondary

Measure	Time frame
MI	one month
Composite of death or MI	one month
Composite of cardiac death or MI	one month
Death (all cause and cardiac)	one month
Target-lesion revascularization (TLR)	yearly up to 5 years
Stent thrombosis (ARC criteria)	one month
Procedural success (defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization)	in-hospital
TVR	one month

Countries

South Korea

Outcome results