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NCT Number: NCT04443530

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gangwon National Univ. Hospital, Chuncheon, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. 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

  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

  5. the composite event rate of cardiac death or myocardial infarction

    Time frame: 5 years

  6. The event rate of target-vessel revascularization

    Time frame: 5 years

  7. The event rate of target-lesion revascularization

    Time frame: 5 years

  8. The event rate of stent thrombosis

    Time frame: 5 years

    According to Academic Research Consortium(ARC) criteria

  9. The event rate of stroke

    Time frame: 5 years

  10. The event rate of procedural success

    Time frame: 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.

  11. The event rate of bleeding complications

    Time frame: 5 years

    TIMI(Thrombolysis in Myocardial Infarction), BARC(Bleeding Academic Research Consortium) criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Jung-hee Ham, RN

CONTACT

[email protected]

82230104728

Sponsors and collaborators

Lead sponsor

Duk-Woo Park, MD

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

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

Acronym: IRIS Tansei

Important dates

Study start
2020
Primary completion
2028
Study completion
2032
First posted
Jun 23, 2020
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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