Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent in Routine Clinical Practice

Study Overview
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Brief Summary
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This study is to evaluate the effectiveness and safety of Ultimaster Tansei stent in the real-world daily practice.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Ultimaster™ Tansei™ stents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 19 years old Patients receiving Ultimaster™ Tansei™ 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 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

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 stenosis<br>Patients with coronary artery disease | Drug: Ultimaster™ Tansei™ stents<br>* Patients receiving Ultimaster™ Tansei™ stents<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 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 years | 
| The event rate of cardiac death |  | 5 years | 
| The event rate of myocardial infarction |  | 5 years | 
| The composite event rate of death or myocardial infarction |  | 5 years | 
| The event rate of target-vessel revascularization |  | 5 years | 
| The event rate of target-lesion revascularization |  | 5 years | 
| The event rate of stent thrombosis | According to 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. | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tansei, Ultimaster, Ultimaster Tansei