PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study

Study Overview
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Brief Summary
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The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.

Official Title
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PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the PROMUS™ Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: Coronary stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: According to Instructions For Use Exclusion Criteria: Contraindications according to Instructions for Use
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 |
| --- | --- |
| Single arm observational study<br>To evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice | Device: Coronary stenting<br>* The PROMUS™ Element™ Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm, 28 mm, 32 mm, 38mm) with a reference vessel diameter of 2.25 mm - 4.0 mm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Failure (TVF) | Overall and PROMUS™ Element™ stent related TVF rate (cardiac death, myocardial infarction (MI) related to target vessel and target vessel re-intervention (TVR)) at 12 months post stent implantation. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR) | Overall and PROMUS™ Element™ stent-related MACE rates (cardiac death, MI, TVR). | 30 days, 6 months, 12 months and then annually through 5 years | 
| Death or MI rates | Overall and PROMUS™ Element™ stent-related cardiac death or MI rates | 30 days, 6 months, 12 months and then annually through 5 years | 
| TVR rates | Overall and PROMUS™ Element™ stent-related TVR rates. | 30 days, 6 months, 12 months and then annually through 5 years | 
| Cardiac death rates | Overall and PROMUS™ Element™ stent-related cardiac death rates. | 30 days, 6 months, 12 months and then annually through 5 years | 
| MI Rates | Overall and PROMUS™ Element™ stent-related MI rates. | 30 days, 6 months, 12 months and then annually through 5 years | 
| All death rates | All death rates | 30 days, 6 months, 12 months and then annually through 5 years | 
| Non-cardiac death rates | Non-cardiac death rates | 30 days, 6 months, 12 months and then annually through 5 years | 
| All death or MI rates | All death and MI rates | 30 days, 6 months, 12 months and then annually through 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary stenting, Drug-eluting stent, Post-market surveillance study, Promus Element stent