Italian Multi-center Registry of Self-apposing Coronary Stent in Patients With STEMI

Study Overview
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Brief Summary
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The aim of this registry is to collect clinical data on nitinol self-expanding STENTYS Xposition S™ in order to evaluate the efficacy and safety in patients presenting with ST segment elevation myocardial infarction

Official Title
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Prospective, Observational, Italian Multi-center Registry of Self-aPposing cOronary Stent in Patients Presenting With ST-segment Elevation Myocardial InfarcTION: the iPOSITION Registry

Conditions
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ST Segment Elevation Myocardial Infarction

Intervention / Treatment
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* Device: STENTYS Xposition S


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age and older presenting with symptoms consistent with a ST-Elevation Myocardial Infarction (STEMI) lasting ≤12 hrs in duration, with ≥2 mm of ST-segment elevation in ≥2 contiguous leads, treated with primary stent implantation (Xposition S planned per operator's assessment). Exclusion Criteria: Cardiogenic shock Multiple lesions requiring stenting in the target vessel. Highly calcified lesions or excessive tortuosity at target lesion site. Intrastent pathology. Subject unable to take or comply with dual antiplatelet therapy as recommended per guidelines. Female subjects of childbearing potential known to be pregnant. Co-morbidities with life expectancy less than 1 year Patient unable to provide written informed consent. Known allergies to stent component.

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| STEMI treated with STENTYS Xposition S<br>Patients 18 years of age and older presenting with symptoms consistent with a ST-Elevation Myocardial Infarction (STEMI) lasting ≤12 hrs in duration, with ≥2 mm of ST-segment elevation in ≥2 contiguous leads, treated with primary stent implantation (Xposition S planned per operator's assessment). | Device: STENTYS Xposition S<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) | target lesion failure will be assessed as the composite of cardiac death; recurrent Target Vessel-Related Myocardial Infarction (MI) and clinically driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods (CABG). | 12 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success without the occurrence of death and repeat ischemia-driven revascularization of the target lesion during the hospital stay |  | during the hospitalization, an average of 6 days | 
| Target lesion failure at 30-day post-procedure |  | 30 day post procedure | 
| Death from any cause |  | 12 months post procedure | 
| Stent thrombosis rate at 30-day and 12-months after the procedure |  | 30 days post procedure and 12 months post procedure |