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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GENOUS EPC-coated stent<br>Patients treated with GENOUS EPC-coated stent | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death (all cause and cardiac) |  | one month | 
| Death (all cause and cardiac) |  | 6 months | 
| Death (all cause and cardiac) |  | yearly up to 5 years | 
| MI |  | one month | 
| MI |  | 6 months | 
| MI |  | yearly up to 5 years | 
| Composite of death or MI |  | one month | 
| Composite of death or MI |  | 6 months | 
| Composite of death or MI |  | yearly up to 5 years | 
| Composite of cardiac death or MI |  | one month | 
| Composite of cardiac death or MI |  | 6 months | 
| Composite of cardiac death or MI |  | yearly up to 5 years | 
| TVR |  | one month | 
| TVR |  | 6 months | 
| TVR |  | yearly up to 5 years | 
| Target-lesion revascularization (TLR) |  | yearly up to 5 years | 
| Target-lesion revascularization (TLR) |  | one month | 
| Target-lesion revascularization (TLR) |  | 6 months | 
| Stent thrombosis (ARC criteria) |  | one month | 
| Stent thrombosis (ARC criteria) |  | 6 months | 
| Stent thrombosis (ARC criteria) |  | yearly up to 5 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting stents