Evaluation of Effectiveness and Safety of XIENCE PRIME Stent (IRIS-PRIME)

Study Overview
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Brief Summary
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The objective of this study is to evaluate effectiveness and safety of XIENCE PRIME stent in the real world daily practice as compared with other drug eluting stents (DESs)

Detailed Description
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This study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of XIENCE PRIME stents versus other DESs in patients with coronary artery disease.

Official Title
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Evaluation of Effectiveness and Safety of XIENCE PRIME™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving XIENCE PRIME 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 presented with cardiogenic shock
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 PRIME stents<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR) |  | 12 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death (all cause and cardiac) |  | one month | 
| Death (all cause and cardiac) |  | 6 months | 
| Death (all cause and cardiac) |  | yearly up to 5 years | 
| MI |  | one month | 
| MI |  | 6 months | 
| MI |  | yearly up to 5 years | 
| Composite of death or MI |  | one month | 
| Composite of death or MI |  | 6 months | 
| Composite of death or MI |  | yearly up to 5 years | 
| Composite of cardiac death or MI |  | one month | 
| Composite of cardiac death or MI |  | 6 months | 
| Composite of cardiac death or MI |  | yearly up to 5 years | 
| TVR |  | one month | 
| TVR |  | 6 months | 
| TVR |  | yearly up to 5 years | 
| Target-lesion revascularization (TLR) |  | one month | 
| Target-lesion revascularization (TLR) |  | 6 months | 
| Target-lesion revascularization (TLR) |  | yearly up to 5 years | 
| Stent thrombosis (ARC criteria) |  | one month | 
| Stent thrombosis (ARC criteria) |  | 6 months | 
| Stent thrombosis (ARC criteria) |  | yearly up to 5 years | 
| 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) |  | At discharge from the index hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease requiring drug eluting stents