Efficacy and Safety of Xience in Coronary arEry Disease aLL-comers After stENTing Using the PRIME Platform (EXCELLENT-PRIME Registry)

Study Overview
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Brief Summary
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Objectives: To evaluate the safety and long-term effectiveness of coronary stenting with the XIENCE PRIMETM in a cohort of real world patients and lesion subsets. To determine clinical device and procedural success during commercial use of XIENCE PRIMETM coronary stent Study population : Approximately consecutive 2000 patients treated with XIENCE PRIMETM Study period Patient enrollment: 2011.05   2012.04 End of follow-up period: 2015. 02 (3 years of follow-up) Primary endpoint : Target Lesion Failure (TLF) rate at 12 months Secondary endpoint: In-stent & In-segment Late Loss at 9 months Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late) Target Vessel Failure at 12 months (composite of cardiac death, MI, and TVR) Any death, cardiac death, MI, TLR, TVR at 30 days, 9months, 1 year, 3 years Composite rate of cardiac death and any MI up to 3 years Composite rate of all death and any MI up to 3 years Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years Procedural success up to 1 day Angiographic success up to 1 day

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: XIENCE PRIMETM everolimus-eluting coronary stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form. Angiographic Inclusion Criteria There are no angiographic inclusion criteria for this study. Exclusion criteria There are no exclusion criteria for this study.

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XIENCE PRIMETM everolimus-eluting coronary stent<br> | Device: XIENCE PRIMETM everolimus-eluting coronary stent<br>* Active prospective registration of patients receiving the following stent : XIENCE PRIMETM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) rate at 12 months |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent & In-segment Late Loss at 9 months |  | 9 months | 
| Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late) |  | 24 hours, 30 days, up to 3 years | 
| Any death, cardiac death, MI, TLR, TVR at 30 days, 9 months, 1 year, 3 years |  | 30 days, 9 months, 1 year, up to 3 years | 
| Composite rate of cardiac death and any MI up to 3 years |  | up to 3 years | 
| Composite rate of all death and any MI up to 3 years |  | up to 3 years | 
| Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years |  | up to 3 years | 
| Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years |  | up to 3 years | 
| procedural success up to 1 day | failure : CK-MB of >3 times the upper limit of normal | 1 day | 
| angiographic success up to 1 day | success : a minimum stenosis diameter reduction to <20% in the presence of grade 3 TIMI flow (assessed by angiography) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Everolimus, XIENCE PRIME, Drug eluting stent