Health TrialsbyHealthPanel

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

ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorDuk-Woo Park, MD

About this trial

This study is to evaluate the effectiveness and safety of Ultimaster Tansei stent and/or Ultimaster Nagomi stent in the "real-world" daily practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with a mixture of other drug-eluting stents (DESs)

Terminal illness with life-expectancy ≤1 year.

Patients with cardiogenic shock

Trial population

Patients with Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stents.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent

    Device

    Patients receiving Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Coronary artery stenosis1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

1

The event rate of all death

Time frame
5 years
2

The event rate of cardiac death

Time frame
5 years
3

The event rate of myocardial infarction

Time frame
5 years
4

The composite event rate of death or myocardial infarction

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duk-Woo Park, MD

Lead sponsor

Asan Medical Center

Sponsor institution

CardioVascular Research Foundation, Korea

Collaborator

Source ClinicalTrials.gov
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