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New balloon treatment for leg artery disease tracked in large Real-World study

NCT ID NCT04776434

Disease control Sponsor: M.A. Med Alliance S.A. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study is tracking how well a drug-coated balloon called SELUTION SLR works in real-world patients with peripheral artery disease (PAD). The balloon is inflated in narrowed leg arteries to open them and release a drug that helps keep them open. Researchers are following 723 people for one year to see how many need a repeat procedure. The goal is to confirm the balloon's safety and effectiveness in everyday medical practice.

What this could mean

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

Active substance
SELUTION SLR drug-coated balloon
What this could lead to
If successful, this could confirm that the SELUTION SLR balloon is a safe and effective option for opening blocked leg arteries and reducing the need for repeat procedures.
What could go wrong
This is an observational study without a comparison group, so it cannot prove the balloon is better than other treatments. Results may not apply to all patients.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

723 people

The number who actually took part.

Started

Feb 2021

Expected to finish

Dec 2028

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.

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: * Subject age is ≥ 18 years * Subject is able and willing to provide informed consent * Subject is suitable for treatment with a MedAlliance SELUTION SLR DEB according to the current Instruction for use. Exclusion Criteria: * In the opinion of the treating investigator the subject has a life expectancy of less than 12 months * In the opinion of the treating investigator the subject is unlikely to comply with the study follow-up regime

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

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

Peripheral artery disease

Contacts and locations

Locations

  • Athens Medical Center

    Athens, Greece

  • Attikon University Hospital

    Athens, Greece

  • Barts Health NHS Trust (ROYAL HOSPITAL LONDON)

    London, United Kingdom

  • DIAKO Krankenhaus

    Flensburg, Germany

  • East Surrey Hospital

    Redhill, United Kingdom

  • Elisabeth - TweeSteden Ziekenhuis

    Tilburg, Netherlands

  • Frimley Park Hospital

    Frimley, United Kingdom

  • General University Hospital of Patras

    Pátrai, Greece

  • Grn Klinik Weinheim

    Weinheim, Germany

  • Guy's & St Thomas Hospital

    London, United Kingdom

  • Hospital Italiano La Plata

    La Plata, Argentina

  • Hôpitaux Universitaires de Genève (HUG)

    Geneva, Switzerland

  • Kantonsspital Aarau

    Aarau, Switzerland

  • Klinikum Hochsauerland

    Arnsberg, Germany

  • Krankenhaus Buchholz

    Buchholz, Germany

  • LMU Klinikum Campus Großhadern

    München, Germany

  • Luzerner Kantonsspital

    Lucerne, Switzerland

  • Medizinisches Versorgungszentrum

    Hamburg, Germany

  • National University Hospital Singapore (NUHS)

    Singapore, Singapore

  • SRH Klinikum Karlsbad - Langensteinbach

    Langensteinbach, Germany

  • Trnava University Hospital

    Trnava, Slovakia

  • University Hospitals of Leicester NHS Trust

    Leicester, United Kingdom

  • Universitätsklinikum Essen

    Essen, Germany

  • Universitätsklinikum Freiburg

    Bad Krozingen, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, Germany

  • Universitätsklinikum Tübingen

    Tübingen, Germany

  • Universitätsklinikum Würzburg

    Würzburg, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.