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New heart stent under review in 3,000-Patient study

NCT ID NCT05698732

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 11, 2026 · Updated 6 times

Summary

This study is checking how well a new drug-coated stent (Coroflex ISAR NEO) works in people with coronary artery disease. Researchers will follow 3,000 patients who get the stent during a routine procedure to see if it keeps arteries open safely. The goal is to confirm the stent meets European safety standards.

What this could mean

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

Active substance
Coroflex® ISAR NEO coronary stent system (a drug-coated stent that releases sirolimus to keep arteries open)
What this could lead to
If successful, this study confirms the stent is safe and effective for treating blocked heart arteries, supporting its continued use in routine care.
What could go wrong
This is an observational follow-up study, not a randomized trial, so results may be less definitive. Stent procedures carry risks like blood clots or artery damage.

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 3,000 people

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

Started

Aug 2023

Expected to finish

Feb 2027

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 treated with Coroflex® ISAR NEO coronary stent system according to routine hospital practice and following instructions for use

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: Coroflex® ISAR NEO is intended to be used for * Patients must be at least 18 years of age AND * The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND * Patients with Novo lesion length 2-4 mm AND * Informed consent signed Exclusion Criteria: * Patients with express refusal by the patient to participate in the study. * Patients pregnant women and lactating women. * Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4). * Patients in whom anti-platelet and/or anti-coagulation therapy is contraindicated * Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation * Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent * Patients with known sensitivity to contrast agents who cannot be premedicated. * Patients with contraindications or hypersensitivity to sirolimus * Patients with a life expectancy of less than 2 years * Patients included in other clinical trials

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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 (CAD) 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

    26 sites in 3 countries. 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

  • APHP -Hôpital Lariboisière

    RECRUITING

    Paris, 75010, France

  • CH Polyclinique Bordeaux Nord Aquitaine

    RECRUITING

    Bordeaux, 33300, France

  • Centre Hospitalier Ajaccio

    RECRUITING

    Ajaccio, 20090, France

  • Centre Hospitalier du Pays d'Aix

    RECRUITING

    Aix-en-Provence, 13100, France

  • Centre hospitalier universitaire (CHU) de Toulouse

    RECRUITING

    Toulouse, 31059, France

  • Clinique Saint-Hilaire

    RECRUITING

    Rouen, France

  • Hospital Clinico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital General Universitario de Ciudad Real

    RECRUITING

    Ciudad Real, 13005, Spain

  • Hospital Regional Universitario de Málaga

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitari Germans Trias I Pujol

    RECRUITING

    Badalona, 08916, Spain

  • Hospital Universitari Vall D Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario A Coruña

    RECRUITING

    A Coruña, 15006, Spain

  • Hospital Universitario Juan Ramon Jimenez

    RECRUITING

    Huelva, 21005, Spain

  • Hospital Universitario Lucus Agusti

    RECRUITING

    Lugo, 27003, Spain

  • Hospital Universitario San Pedro de Alcantara

    RECRUITING

    Cáceres, 10003, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario de Badajoz

    RECRUITING

    Badajoz, 06080, Spain

  • Hospital Universitario de Cruces

    RECRUITING

    Barakaldo, 48903, Spain

  • Hospital Universitario de Leon

    RECRUITING

    León, 24071, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08025, Spain

  • Hospitalario Universitario (CHU) de Lille

    RECRUITING

    Lille, 59000, France

  • Hôpital Albert Schweitzer

    RECRUITING

    Colmar, France

  • Institut Arnault Tzanck

    RECRUITING

    Saint-Laurent-du-Var, 06700, France

  • King's Mill Hospital, Sherwood Forest Hospitals

    NOT_YET_RECRUITING

    Sutton in Ashfield, United Kingdom

  • Royal Albert Edward Infirmary

    RECRUITING

    Wigan, United Kingdom

  • University Hospital Center of Caen

    RECRUITING

    Caen, 14000, France

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