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New stent study aims to improve heart disease treatment

NCT ID NCT04443530

Disease control Sponsor: Duk-Woo Park, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is tracking 2,000 people with coronary artery disease who receive Ultimaster stents during routine care. Researchers want to see how often serious heart problems like death, heart attack, or the need for another procedure happen within a year. The goal is to understand how well these stents work in everyday medical practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ultimaster Tansei and Nagomi stents (medical devices placed in heart arteries)
What this could lead to
If successful, this could confirm that these stents are safe and effective for everyday use in people with blocked heart arteries.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove the stents are better than other options. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Daegu Catholic University Medical Center

    RECRUITING

    Daegu, South Korea

  • Gangneung Asan Hospital

    RECRUITING

    Gangneung, South Korea

  • Gangwon National Univ. Hospital

    WITHDRAWN

    Chuncheon, South Korea

  • Kangdong Sacred Heart Hospital

    RECRUITING

    Seoul, South Korea

  • Keimyung University Dongsan Medical Center

    RECRUITING

    Daegu, South Korea

  • Kwangju Christian Hospital

    RECRUITING

    Kwangju, South Korea

  • Pusan National University Hospital

    RECRUITING

    Pusan, South Korea

  • St.Carollo Hospital

    RECRUITING

    Suncheon, South Korea

  • The Catholic Univ. of Korea Eunpyeong St. Mary's hospital

    WITHDRAWN

    Seoul, South Korea

  • The Catholic University of Korea, Daejeon ST. Mary's Hospital

    RECRUITING

    Daejeon, South Korea

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