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New stent design tested in thousands with complex heart blockages

NCT ID NCT05705973

Disease control Sponsor: Terumo Europe N.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study follows about 3000 people with complex coronary artery disease who receive the Ultimaster Nagomi stent, a device that slowly releases a drug to keep arteries open. The goal is to see how often the stent fails—meaning heart-related death, heart attack, or need for another procedure—in real-world, challenging cases. Researchers are tracking success rates and complications to better understand the stent's performance outside of controlled trials.

What this could mean

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

Active substance
sirolimus-eluting coronary stent
What this could lead to
If successful, this could confirm that the Ultimaster Nagomi stent is safe and effective for people with complex coronary artery blockages.
What could go wrong
This is an observational follow-up, not a randomized trial, so results may be less definitive. Stents carry risks like blood clots or re-narrowing of the artery.

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

3,000 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Subjects who have signed the informed consent are considered enrolled upon insertion of the first Ultimaster NagomiTM stent is successfully implanted and the complex procedure criteria are confirmed. It is expected that study enrolment will take approximately 1.5 years. Enrolment will be competitive, i.e. enrolment will be closed once the total number of subjects has been reached irrespective of the number of subjects per individual site. Individual sites can not enroll more than 300 subjects. The enrolled patient population is expected to be representative for complex patients because of the limited exclusion criteria and the participation of multiple sites from across Europe

Ages

18 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.

General Inclusion Criteria: 1. Age ≥ 18 years 2. Patient has been informed of the nature of the study and agrees to its provisions, has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site 3. Ischemic heart disease with an indication for a PCI with, if available and per hospital guidelines, Heart Team consensus for a PCI procedure 4. Intention to treat all lesions requiring a PCI with the Ultimaster Nagomi stent Complex Procedure Inclusion Criteria Subject meets ≥ 1 of the complex procedure criteria: 1. Multivessel PCI defined as ≥ 2 native coronary arteries and/or venous or arterial bypass grafts treated with a stent 2. ≥ 3 stents implanted 3. ≥ 3 lesions treated 4. Complex bifurcation lesion defined as true bifurcation lesion (Medina 1.1.1, 1.0.1 or 0.1.1) with a side branch diameter ≥ 2.5 mm plus one of the following: i) side branch disease \> 10 mm ii) calcified lesion iii) thrombotic lesion e) Bifurcation lesion implanted with two stents f) Total stent length implanted \> 60 mm g) Chronic total occlusion defined as a 100% occlusion with antegrade TIMI 0 flow with at least a 3-month duration h) Left main stenting (main stem and/or bifurcation) i) In-stent restenosis j) Severe calcified lesion with use of atherectomy, lithotripsy or cutting balloon Exclusion Criteria: 1. Any surgery requiring general anaesthesia, comorbidity or indication likely necessitating the discontinuation of dual anti-platelet therapy before the recommended duration of dual anti-platelet therapy per the ESC or national guidelines 2. Hypersensitivity or contraindication to aspirin, heparin, L605 cobalt-chromium alloy, sirolimus or its structurally related compounds, lactide polymers or caprolactone polymers that cannot be pre-medicated 3. Known contrast sensitivity that cannot be premedicated 4. Pregnant and breastfeeding women 5. Life expectancy \< 1 year for any cardiac or non-cardiac cause 6. Participation in another clinical study that has not yet completed its primary endpoint 7. Earlier enrolment in the Nagomi Complex study 8. Unlikely to be available for follow-up during the duration of the study (2 years)

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Coronary Occlusion myocardial ischemia

As listed by the trial registrant

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

Cardiovascular disease Coronary artery occlusion Ischemic heart disease

Contacts and locations

Locations

  • Albert Schweitzer Ziekenhuis

    Dordrecht, Netherlands

  • Altnagelvin Area Hospital

    Londonderry, United Kingdom

  • Bellvitge University Hospital

    Barcelona, Spain

  • C.H.U. Charleroi

    Charleroi, Belgium

  • CHR Citadelle

    Liège, Belgium

  • CHU Jean Minjoz

    Besançon, France

  • CHU UCL Mont Godinne Namur

    Yvoir, Belgium

  • Catharina Hospital Eindhoven

    Eindhoven, Netherlands

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, France

  • Clinique Louis Pasteur

    Essey-lès-Nancy, France

  • Clinique Pasteur

    Toulouse, France

  • Clinique Saint-Hilaire

    Rouen, France

  • Clinique Saint-Luc Bouge

    Namur, Belgium

  • Dedinje Cardiovascular Institute

    Belgrade, Serbia

  • East Tallinn Central Hospital

    Tallinn, Estonia

  • Galway University Hospital

    Galway, Ireland

  • Gävle Hospital

    Gävle, Sweden

  • Hopital de Jolimont

    La Louvière, Belgium

  • Hospital Universitario Juan Ramón Jiménez

    Huelva, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • Hospital Universitario de León

    León, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Hôpital Foch

    Suresnes, France

  • Hôpital Louis Pradel

    Bron, France

  • Hôpital Privé Jacques Cartier

    Massy, France

  • Hôpital de la Croix Rousse

    Lyon, France

  • IRCCS Istituto Auxologico Italiano

    Milan, Italy

  • Imelda Hospital

    Bonheiden, Belgium

  • Istituto Cardiocentro Ticino

    Lugano, Switzerland

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, Netherlands

  • Karolinska University Hospital

    Huddinge, Sweden

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, Austria

  • Lincolnshire Heart Centre Lincoln County Hospital

    Lincoln, United Kingdom

  • London North West University Healthcare NHS Trus

    London, United Kingdom

  • Luzerner Kantonsspital

    Lucerne, Switzerland

  • Maasstad Ziekenhuis

    Rotterdam, Netherlands

  • Mater Private Hospital

    Dublin, Ireland

  • Mater Private Network

    Cork, Ireland

  • Medisch Centrum Leeuwarden

    Leeuwarden, Netherlands

  • Monzino Cardiology Center

    Milan, Italy

  • Newcastle Freeman Hospital

    Newcastle upon Tyne, United Kingdom

  • Rijnstate Ziekenhuis

    Arnhem, Netherlands

  • Royal Sussex County Hospital

    Brighton, United Kingdom

  • Salamanca University Hospital

    Salamanca, Spain

  • UZ Leuven

    Leuven, Belgium

  • University Clinical Center of Serbia

    Belgrade, Serbia

  • University Hospital Plymouth NHS trust

    Plymouth, United Kingdom

  • University Hospital of North Midlands

    Newcastle, United Kingdom

  • Universitätsspital Basel

    Basel, Switzerland

  • Uniwersytecki Szpital Kliniczny w Poznaniu Oddział Kardiologii

    Poznan, Poland

  • Worcestershire Royal Hospital

    Worcester, United Kingdom

  • Ziekenhuis Oost-Limburg

    Genk, Belgium

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