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New long stent aims to simplify treatment of tough heart blockages

NCT ID NCT07399002

Disease control Sponsor: Fundación EPIC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study is testing a long version of the Ultimaster Nagomi stent in people with long blockages in their heart arteries. About 1,039 participants will receive the stent and be followed for one year to see if it works well and stays safe. The goal is to see if one long stent can replace the need for multiple shorter stents.

What this could mean

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

Active substance
Ultimaster Nagomi stent (a long, flexible mesh tube placed in the artery to keep it open)
What this could lead to
If successful, this could confirm that using a single long stent is a safe and effective way to treat long blockages in heart arteries, potentially simplifying procedures.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. Risks include stent failure, blood clots, or need for repeat procedures.

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 1,039 people

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

Started

Feb 2026

Expected to finish

Jan 2029

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 undergoing PCI with implantation of a Long Nagomi stent

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.

Inclusion Criteria: * Patients who meet ALL inclusion criteria will be included: * Patients aged ≥ 18 years AND; * Patients who according to standard practice of the hospital are amenable to PCI as indicated and considered adequate according to the European clinical practice guidelines on coronary revascularization AND; * Patients with at least one lesion fulfilling the "long lesion criteria" suitable for a single stent approach AND; * Patients who have been informed of the characteristics of the study and have provided written informed consent AND; * Intention to treat all lesions with the Ultimaster Nagomi™ stent Exclusion Criteria: * Patients must not meet any of the following exclusion criteria: * Patients who expressly decline to participate in the study. * Pregnant or breastfeeding women. * Patients with acute coronary syndrome (ACS) under conditions of cardiogenic shock (Killip class 4). * Patients with contraindications or hypersensitivity to sirolimus. * Patients with a life expectancy of less than 2 years. * Patients in whom any surgery requiring general anesthesia is planned, 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. * Patients included in other clinical trials that did not reach the primary objective.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder myocardial ischemia

As listed by the trial registrant

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

Coronary artery disease Ischemic heart disease

How to take part

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

  1. The places running it

    10 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

  • Hospital General Universitario de Ciudad Real

    RECRUITING

    Ciudad Real, 13005, Spain

  • Hospital General Universitario de Elche

    RECRUITING

    Elche, 03203, Spain

  • Hospital Universitario Juan Ramón Jiménez

    RECRUITING

    Huelva, 21005, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, 39008, Spain

  • Hospital Universitario Regional de Málaga

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario de Cabueñes

    RECRUITING

    Cabueñes, 33394, Spain

  • Hospital Universitario de Leon

    RECRUITING

    León, 24008, Spain

  • Hospital Universitario de Navarra

    RECRUITING

    Pamplona, 31008, Spain

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