Coronary Artery DiseaseIRIS TanseiNCT04443530
Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent and/or Ultimaster Nagomi™ Stent in Routine Clinical Practice
An observational study of Coronary Artery Disease, run by Duk-Woo Park, MD at 11 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 11 sitesSouth Korea
- Study dates
- 17 Sep 2020to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stents.
Who may be able to join
- 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.
Who cannot join
- Patients with a mixture of other drug-eluting stents (DESs)
- Terminal illness with life-expectancy ≤1 year.
- Patients with cardiogenic shock
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
South Korea11 sites, 9 recruiting
- Withdrawn
Gangwon National Univ. Hospital
Chuncheon
- Recruiting
Daegu Catholic University Medical Center
Daegu
Jin-bae Lee, MD
Jin-bae Lee, MD
- Recruiting
Keimyung University Dongsan Medical Center
Daegu
Hyuck-joon Yoon, MD
Hyuck-joon Yoon, MD
- Recruiting
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
Man-won Park, MD
Man-won Park, MD
- Recruiting
Gangneung Asan Hospital
Gangneung
Han-bit Park, MD
Han-bit Park, MD
- Recruiting
Kwangju Christian Hospital
Kwangju
Seung-uk Lee, MD
Seung-uk Lee, MD
- Recruiting
Pusan National University Hospital
Pusan
Han-cheol Lee, MD
Han-cheol Lee, MD
- Recruiting
Asan Medical Center
Seoul
Duk-woo Park, MD, dwpark@amc.seoul.kr
Duk-woo Park, MD
- Recruiting
Kangdong Sacred Heart Hospital
Seoul
Won-woo Seo, MD
Won-woo Seo, MD
- Withdrawn
The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
Seoul
- Recruiting
St.Carollo Hospital
Suncheon
Jang-hyun Cho, MD
Jang-hyun Cho, MD
About this study
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
This study is to evaluate the effectiveness and safety of Ultimaster Tansei stent and/or Ultimaster Nagomi stent in the "real-world" daily practice.
- Conditions
- Coronary Artery Disease
- Being tested
- Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent
- Keywords
- Tansei, Ultimaster, Ultimaster Tansei
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stentDevice
Patients receiving Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent
| Study group | Role | What they receive |
|---|---|---|
| Coronary artery stenosis | Patients with coronary artery disease Receives: Device: Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (11)
The event rate of all death
Measured: 5 years
The event rate of cardiac death
Measured: 5 years
The event rate of myocardial infarction
Measured: 5 years
The composite event rate of death or myocardial infarction
Measured: 5 years
the composite event rate of cardiac death or myocardial infarction
Measured: 5 years
The event rate of target-vessel revascularization
Measured: 5 years
The event rate of target-lesion revascularization
Measured: 5 years
The event rate of stent thrombosis
According to Academic Research Consortium(ARC) criteria
Measured: 5 years
The event rate of stroke
Measured: 5 years
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.
Measured: 3 days
The event rate of bleeding complications
TIMI(Thrombolysis in Myocardial Infarction), BARC(Bleeding Academic Research Consortium) criteria
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start17 Sep 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duk-Woo Park, MD
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Duk-Woo Park, MD, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443530
- Sponsor's protocol ID
- AMCCV2020-07
- Acronym
- IRIS Tansei
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2020
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04443530
- Acronym / sponsor ID
- IRIS Tansei / AMCCV2020-07
- Conditions
- Coronary Artery Disease
- Keywords
- Tansei, Ultimaster, Ultimaster Tansei
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Duk-Woo Park, MDUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary artery stenosis | – | Device: Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stentPatients with coronary artery disease |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stents.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with a mixture of other drug-eluting stents (DESs)
- Terminal illness with life-expectancy ≤1 year.
- Patients with cardiogenic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stentPatients receiving Ultimaster™ Tansei™ stent and/or Ultimaster Nagomi™ stent | Device | Coronary artery stenosis |
Primary outcome
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Duk-Woo Park, MD at 11 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-hee Ham, RN (82230104728, cvcrc5@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.