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New Drug-Coated stent tested for clogged heart arteries

NCT ID NCT06621524

Disease control Sponsor: OrbusNeich 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking 251 patients with symptomatic coronary heart disease who received the EucaLimus stent, a sirolimus-coated device designed to keep arteries open. The goal is to see how well the stent works and how safe it is over the long term in real-world use. Researchers will monitor for heart-related deaths, heart attacks, or the need for repeat procedures.

What this could mean

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

Active substance
sirolimus drug-coated stent
What this could lead to
If successful, this could confirm that the EucaLimus stent is safe and effective for treating blocked heart arteries in everyday practice.
What could go wrong
This is an observational registry, not a randomized trial, so results may be less definitive. Stent procedures carry risks like blood clots or re-narrowing.

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

251 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Jan 2029

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

Patients with symptomatic ischaemic coronary heart disease due to de novo lesions or restenosis lesions of the coronary arteries, or patients with acute or suspected occlusions who responded unsuccessfully to an interventional therapy following balloon dilatation.

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: * Consecutive patients intended to be, or treated by EucaLimus as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry. Exclusion Criteria: * Patients are excluded from registration if ANY of the following conditions apply: * High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned * A life expectancy of \<1year * Explicit refusal of participation in the registry

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Conditions

The condition(s) this trial relates to.

arteriosclerosis disorder cardiovascular disorder coronary artery disorder coronary atherosclerosis Coronary Disease heart disorder myocardial ischemia

As listed by the trial registrant

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

Coronary arterioscleroses

Contacts and locations

Locations

  • Bellvitge University Hospital

    L'Hospitalet de Llobregat, Catalonia, 08907, Spain

  • Complejo Hospitalario Universitario de Canarias

    San Cristóbal de La Laguna, 38320, Spain

  • Hospital Universitario Joan XXIII

    Tarragona, 43005, Spain

  • Hospital Universitario Lucus Augusti

    Lugo, 27003, Spain

  • Hospital Universitario Reina Sofía

    Córdoba, 14004, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08026, Spain

  • Institut Jantung Negara

    Kuala Lumpur, 50400, Malaysia

  • Krajska nemocnice Liberec

    Liberec, 46001, Czechia

  • Motol University Hospital

    Prague, 15006, Czechia