Clinical trial Recruiting at 9 sites Observational Ages 19 and up

Evaluating the Ultimaster Tansei Stent for Coronary Artery Disease

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

Run by Asan Medical Center · NCT04443530 · Data updated 2026-11-12

This study is testing how well the Ultimaster Tansei stent works and is safe for people with coronary artery disease in real-life situations.

Quick facts

Study typeObservational
Ages19 Years and up
SexAll
Enrollment2000 (estimated)
SponsorAsan Medical Center
Academic / other
Locations11 sites (Chuncheon and 10 other locations)
StatusRecruiting
StartedSeptember 17, 2020
Main results expectedDecember 31, 2028
Study endsDecember 31, 2032
Registry record updatedJune 26, 2026
Trial IDNCT04443530 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients aged 19 and older who are receiving Ultimaster Tansei stents.

Probably not a fit

Patients with terminal illnesses or those experiencing cardiogenic shock may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the effectiveness and safety of the Ultimaster Tansei stent in treating patients with coronary artery disease in everyday clinical settings. It involves monitoring patients who receive this specific stent and collecting data on their outcomes over time. The observational nature of the study allows for real-world insights into the stent's performance and patient experiences.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the safety and effectiveness of the Ultimaster Tansei stent, potentially improving treatment options for patients with coronary artery disease.

How similar studies have gone: While this study focuses on a specific stent, similar observational studies have shown success in evaluating the effectiveness of various stents in real-world settings.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Daegu Catholic University Medical Center
    Daegu, South Korea
    Recruiting
  • Keimyung University Dongsan Medical Center
    Daegu, South Korea
    Recruiting
  • The Catholic University of Korea, Daejeon ST. Mary's Hospital
    Daejeon, South Korea
    Recruiting
  • Gangneung Asan Hospital
    Gangneung, South Korea
    Recruiting
  • Kwangju Christian Hospital
    Kwangju, South Korea
    Recruiting
  • Pusan National University Hospital
    Pusan, South Korea
    Recruiting
Show 5 more locations
  • Asan Medical Center
    Seoul, South Korea
    Recruiting
  • Kangdong Sacred Heart Hospital
    Seoul, South Korea
    Recruiting
  • St.Carollo Hospital
    Suncheon, South Korea
    Recruiting
  • Gangwon National Univ. Hospital
    Chuncheon, South Korea
    Withdrawn
  • The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
    Seoul, South Korea
    Withdrawn

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.