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Recruiting NCT04443530

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

— Observational Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • The composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) [Time frame: 1 year]
Secondary outcome measures (11)
  • The event rate of all death [Time frame: 5 years]
  • The event rate of cardiac death [Time frame: 5 years]
  • The event rate of myocardial infarction [Time frame: 5 years]
  • The composite event rate of death or myocardial infarction [Time frame: 5 years]
  • the composite event rate of cardiac death or myocardial infarction [Time frame: 5 years]
  • The event rate of target-vessel revascularization [Time frame: 5 years]
  • The event rate of target-lesion revascularization [Time frame: 5 years]
  • The event rate of stent thrombosis [Time frame: 5 years]
  • The event rate of stroke [Time frame: 5 years]
  • The event rate of procedural success [Time frame: 3 days]
  • The event rate of bleeding complications [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 11 centers
  • Gangwon National Univ. Hospital — Chuncheon
  • Daegu Catholic University Medical Center — Daegu
  • Keimyung University Dongsan Medical Center — Daegu
  • The Catholic University of Korea, Daejeon ST. Mary's Hospital — Daejeon
  • Gangneung Asan Hospital — Gangneung
  • Kwangju Christian Hospital — Kwangju
  • Pusan National University Hospital — Pusan
  • Asan Medical Center — Seoul
  • … and 3 more centers

Identifiers

NCT: NCT04443530 · AMCCV2020-07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗