Evaluation of Effectiveness and Safety of Xience Skypoint Stents in Routine Clinical Practice

Study Overview
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Brief Summary
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The objective of this study is to evaluate the effectiveness and safety of XIENCE Skypoint stents in comparison to other drug-eluting stents (DES) in real-world practice.

Official Title
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a Non-randomized, Prospective, Open-label Registry to Compare the Effectiveness and Safety of XIENCE Skypoint™ Stents Versus Other DESs in Patients With Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: XIENCE Skypoint™ stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 19 years old Patients receiving Xience-Skypoint™ stents. 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

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| XIENCE Skypoint™ stent<br>Patients receiving Xience-Skypoint™ stents | Device: XIENCE Skypoint™ stent<br>* Percutaneous coronary intervention with Xience-Skypoint™ stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) | the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the event rate of all cause death |  | 5 years | 
| the event rate of cardiac death |  | 5 years | 
| the event rate of nonfatal myocardial infarction |  | 5 years | 
| the composite event rate of death, or nonfatal myocardial infarction (MI) |  | 5 years | 
| the composite event rate of cardiac death, or nonfatal myocardial infarction (MI) |  | 5 years | 
| the event rate of Target- Vessel Revascularization (TVR) |  | 5 years | 
| the event rate of Target- lesion Revascularization (TLR) |  | 5 years | 
| the event rate of stent thrombosis | according to an Academic Research Consortium (ARC) criteria | 5 years | 
| the event rate of stroke |  | 5 years | 
| the event rate of 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. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting stent, Percutaneous Coronary Intervention