TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study (TE-Prove)

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

Detailed Description
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A prospective, open label, multi-center observational study with an all-comers enrollment approach of approximately 1000 subjects at up to 50 sites in Europe.

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 TAXUS® 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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* Procedure: Coronary artery 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 |
| --- | --- |
| Coronary artery stenting<br>All subjects who are candidates for coronary artery stenting, signed the Informed Consent Form and are eligible to receive a TAXUS Element stent will be evaluated for enrollment in this study. | Procedure: Coronary artery stenting<br>* Coronary artery stenting with drug eluting stents<br>* Other names: TAXUS Element;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel failure | Overall and TAXUS Element stent related Target Vessel Failure (TVF) rate (cardiac death, myocardial infarction (MI) related to target vessel and target vessel re-intervention (TVR)) at 12 months post stent implantation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Thrombosis | Stent Thrombosis (ST) rate using Academic Research Consortium (ARC) definition (definite/probable with no censoring for Target Lesion Reintervention, (TLR)). | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | 
| MACE | Overall and TAXUS Element stent-related Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR). | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | 
| Cardiac Death or MI | Overall and TAXUS Element stent-related cardiac death or MI rates | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | 
| TVR | Overall and TAXUS Element stent-related TVR rates | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | 
| Cardiac Death | Overall and TAXUS Element stent-related cardiac death rates | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | 
| MI | Overall and TAXUS Element stent-related MI rates | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | 
| All Death | All Death rates | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | 
| Non-Cardiac Death | Non-Cardiac Death rates | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | 
| All Death or MI | All Death or MI rates | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Eluting Stents, Observational, All-Comers