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

June 24, 2026 updated by: Duk-Woo Park, MD

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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        • Withdrawn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        • Withdrawn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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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:

  1. Patients with a mixture of other drug-eluting stents (DESs)
  2. Terminal illness with life-expectancy ≤1 year.
  3. Patients with cardiogenic shock

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary artery stenosis
Patients with coronary artery disease
Device: Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent
Patients receiving Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The event rate of all death
Time Frame: 5 years
5 years
The event rate of cardiac death
Time Frame: 5 years
5 years
The event rate of myocardial infarction
Time Frame: 5 years
5 years
The composite event rate of death or myocardial infarction
Time Frame: 5 years
5 years
The event rate of target-vessel revascularization
Time Frame: 5 years
5 years
The event rate of target-lesion revascularization
Time Frame: 5 years
5 years
The event rate of stent thrombosis
Time Frame: 5 years
According to Academic Research Consortium(ARC) criteria
5 years
The event rate of stroke
Time Frame: 5 years
5 years
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.
3 days
the composite event rate of cardiac death or myocardial infarction
Time Frame: 5 years
5 years
The event rate of bleeding complications
Time Frame: 5 years
TIMI(Thrombolysis in Myocardial Infarction), BARC(Bleeding Academic Research Consortium) criteria
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duk-Woo Park, MD

Collaborators

CardioVascular Research Foundation, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

June 21, 2020

First Submitted That Met QC Criteria

June 21, 2020

First Posted (Actual)

June 23, 2020

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV2020-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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