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Thousands tracked to see how a Drug-Coated stent performs in daily use

NCT ID NCT05505929

Disease control Sponsor: Biosensors Europe SA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 2 times

Summary

This registry is following 10,000 people who receive the BioFreedom Ultra stent, a device coated with the drug biolimus A9 to keep heart arteries open. The goal is to see how well the stent works in real-world patients, not just in controlled trials. Researchers will track problems like the need for repeat procedures, heart attacks, or stent blockages over time.

What this could mean

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

Active substance
Biolimus A9-coated coronary stent
What this could lead to
If successful, this registry will confirm that the BioFreedom Ultra stent works safely in everyday patients, supporting its continued use for coronary artery disease.
What could go wrong
This is an observational registry, not a controlled trial, so results may be influenced by patient differences. It does not test a new treatment, only monitors existing practice.

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 10,000 people

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

Started

Jun 2023

Expected to finish

Mar 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

This observational registry is open to all patients with coronary artery disease treated by percutaneous coronary intervention (PCI) with one or more BioFreedom™ Ultra CoCr DCS within the products indications of the Instructions for Use (IFU).

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: * According to the current version of Instructions of Use (IFU) * Patient is at least 18 years old * Patient provides a signed informed consent Exclusion Criteria: * According to current version of IFU * Patients will be excluded as per Medical Device Regulation (MDR) (Article 65: "Clinical investigations on minors" and article 66: "Clinical investigations on pregnant or breastfeeding women" * Patients will be excluded if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision

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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.

Post market clinical follow up (PMCF)

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 in 8 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

  • Al Qassimi Hospital

    RECRUITING

    Sharjah city, United Arab Emirates

  • Clinique Des Domes Psr

    RECRUITING

    Clermont-Ferrand, France

  • Golden Jubilee National Hospital

    RECRUITING

    Glasgow, United Kingdom

  • Hospital Marques Valdecilla

    RECRUITING

    Santander, Spain

  • Klinikum Lippe

    RECRUITING

    Detmold, Germany

  • Krankenhaus Barmherzige Brüder

    RECRUITING

    Eisenstadt, Austria

  • Military hospital

    RECRUITING

    Tunis, Tunisia

  • Royal Bournemouth hospital

    RECRUITING

    Bournemouth, United Kingdom

  • University and Hospital Fribourg

    RECRUITING

    Fribourg, Switzerland

  • Universitäres Herzzentrum

    RECRUITING

    Zurich, Switzerland

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