Evaluation of Effectiveness and Safety of Synergy XD and Synergy Megatron™ Stent

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 Synergy XD stent and Synergy Megatron™ Stent in the real world daily practice as compared with the other drug-eluting stents.

Detailed Description
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This study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of Synergy XD stent and Synergy Megatron™ Stents versus other drug-eluting stents (DES) in patients with coronary artery disease.

Official Title
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Evaluation of Effectiveness and Safety of Synergy™ XD Stent and Synergy Megatron™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Conditions
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Coronary Artery Disease, Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Coronary Disease

Intervention / Treatment
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* Device: Synergy XD stent or Synergy Megatron™ Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 19 years old Patients receiving Synergy XD stent(s) or Synergy Megatron™ stent(s). 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 drug-eluting stents (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

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 Disease<br> | Device: Synergy XD stent or Synergy Megatron™ Stent<br>* Percutaneous coronary intervention with Synergy XD stent or Synergy Megatron™ 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, non-fatal myocardial infarction, or target vessel revascularization | A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The event rate of all death |  | 5-year | 
| The event rate of cardiac death |  | 5-year | 
| The event rate of myocardial infarction |  | 5-year | 
| The composite event rate of death or myocardial infarction |  | 5-year | 
| The composite event rate of cardiac death or myocardial infarction |  | 5-year | 
| The event rate of target-vessel revascularization |  | 5-year | 
| The event rate of target-lesion revascularization |  | 5-year | 
| The event rate of stent thrombosis | According to Academic Research Consortium(ARC) criteria | 5-year | 
| The event rate of stroke |  | 5-year | 
| The event rate of procedural success | Defined as achievement of final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave myocardial infarction, or urgent revascularization during the index hospitalization. | 3 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, real world