Coronary Artery Disease
Conditions
Keywords
Tansei, Ultimaster, Ultimaster Tansei
Brief summary
This study is to evaluate the effectiveness and safety of Ultimaster Tansei stent and/or Ultimaster Nagomi stent in the "real-world" daily practice.
Interventions
DEVICEUltimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent
Patients receiving Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent
Sponsors
Duk-Woo Park, MD
CardioVascular Research Foundation, Korea
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥ 19 years old 2. Patients receiving Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stents. 3. 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
1. Patients with a mixture of other drug-eluting stents (DESs) 2. Terminal illness with life-expectancy ≤1 year. 3. Patients with cardiogenic shock
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 composite event rate of cardiac 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 | 5 years | According to Academic Research Consortium(ARC) criteria |
| The event rate of stroke | 5 years | — |
| The event rate of procedural success | 3 days | 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. |
| The event rate of bleeding complications | 5 years | TIMI(Thrombolysis in Myocardial Infarction), BARC(Bleeding Academic Research Consortium) criteria |
Countries
South Korea
Contacts
CONTACTJung-hee Ham, RN
Outcome results
None listed