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RecruitingNCT04443530IRIS TanseiUpdated Jun 26, 2026

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

An observational study in Coronary Artery Disease, sponsored by Duk-Woo Park, MD. Recruiting at 11 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.

Sponsored by Duk-Woo Park, MD · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Tansei
  • Ultimaster
  • Ultimaster Tansei
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Coronary artery stenosis

    Patients with coronary artery disease

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

Interventions

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

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

05

What researchers measure

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

  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

    According to Academic Research Consortium(ARC) criteria

    Time frame: 5 years

  9. The event rate of stroke

    Time frame: 5 years

  10. The event rate of procedural success

    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.

    Time frame: 3 days

  11. The event rate of bleeding complications

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

    Time frame: 5 years

06

Study locations

9 of 11 sites recruiting
  • Gangwon National Univ. Hospital
    Chuncheon, South Korea
    Withdrawn
  • Daegu Catholic University Medical Center
    Daegu, South Korea
    • Jin-bae Lee, MD · Contact
    • Jin-bae Lee, MD · Principal investigator
    Recruiting
  • Keimyung University Dongsan Medical Center
    Daegu, South Korea
    • Hyuck-joon Yoon, MD · Contact
    • Hyuck-joon Yoon, MD · Principal investigator
    Recruiting
  • The Catholic University of Korea, Daejeon ST. Mary's Hospital
    Daejeon, South Korea
    • Man-won Park, MD · Contact
    • Man-won Park, MD · Principal investigator
    Recruiting
  • Gangneung Asan Hospital
    Gangneung, South Korea
    • Han-bit Park, MD · Contact
    • Han-bit Park, MD · Principal investigator
    Recruiting
  • Kwangju Christian Hospital
    Kwangju, South Korea
    • Seung-uk Lee, MD · Contact
    • Seung-uk Lee, MD · Principal investigator
    Recruiting
  • Pusan National University Hospital
    Pusan, South Korea
    • Han-cheol Lee, MD · Contact
    • Han-cheol Lee, MD · Principal investigator
    Recruiting
  • Asan Medical Center
    Seoul, South Korea
    Recruiting
  • Kangdong Sacred Heart Hospital
    Seoul, South Korea
    • Won-woo Seo, MD · Contact
    • Won-woo Seo, MD · Principal investigator
    Recruiting
  • The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
    Seoul, South Korea
    Withdrawn
  • St.Carollo Hospital
    Suncheon, South Korea
    • Jang-hyun Cho, MD · Contact
    • Jang-hyun Cho, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04443530
Lead sponsor
Duk-Woo Park, MD
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Duk-Woo Park, MD (Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Asan Medical Center) — Sponsor-investigator
First posted
Jun 23, 2020
Start date
Sep 17, 2020
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Jun 26, 2026

Study contacts

Jung-hee Ham, RN
Contact
cvcrc5@amc.seoul.kr
82230104728

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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