Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent and/or Ultimaster Nagomi™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 2,000
- Locations
- 17
- Primary Endpoint
- The composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients ≥ 19 years old
- •Patients receiving Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ 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
Outcomes
Primary Outcomes
The composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Time Frame: 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 Outcomes
- The event rate of cardiac death(5 years)
- The event rate of all 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)
- The event rate of stroke(5 years)
- The event rate of procedural success(3 days)
- The event rate of bleeding complications(5 years)
Investigators
Duk-Woo Park, MD
Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine
Asan Medical Center