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New balloon coated with drug aims to keep leg arteries open longer

NCT ID NCT06832631

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study follows 284 people with blocked leg arteries (peripheral arterial disease) who are treated with a paclitaxel-coated balloon. The balloon is inflated inside the artery to open it and release a drug that helps prevent it from narrowing again. Researchers are tracking safety and how well the artery stays open 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
paclitaxel-coated balloon
What this could lead to
If successful, this could confirm that the paclitaxel-coated balloon is a safe and effective way to open blocked leg arteries and reduce the need for repeat procedures.
What could go wrong
This is an observational registry, not a randomized trial, so results may be less definitive. The drug coating may carry risks like inflammation or late complications, and long-term benefits are still being studied.

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

283 people

The number who actually took part.

Started

May 2025

Expected to finish

Jun 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 peripheral arterial disease

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 the VITUS peripheral drug-coated dilatation catheter as per physicians' decision and according to IFU in the setting of routine clinical care are entered into the registry * The lesion to be treated should be shorter than the nominal length of balloon at a reference vessel diameter of 2.0 mm up to 7.0 mm. * If lesion is longer than the individual balloon, more than one DCB can be used for longer lesions with the mandatory overlapping balloons of 10mm to avoid any geographical miss. * Rutherford clinical categories 2-5 Exclusion Criteria: * The 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 in peripheral arteries is planned * A life expectancy of \<1year * Explicit refusal of participation in the registry * Residual stenosis \>50% after vessel preparation

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease peripheral arterial occlusive disease 1

As listed by the trial registrant

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

Peripheral arterial disease Peripheral arterial occlusive disease

Contacts and locations

Locations

  • AZ Groennge

    Kortrijk, 3000, Belgium

  • AZ Jan Portaels

    Vilvoorde, 1800, Belgium

  • AZ Sint-Blasius

    Dendermonde, 9200, Belgium

  • AZORG

    Aalst, 9300, Belgium

  • Complejo Hospitalario Universitario de Ourense

    Ourense, 32005, Spain

  • Hospital General de Granollers

    Granollers, 08402, Spain

  • Hospital Universitario de Cabueñes

    Gijón, 33394, Spain

  • Hospital Universitario de Toledo

    Toledo, 45007, Spain

  • Klinikum Lippe Detmold

    Detmold, 32756, Germany

  • RZ Heilig Hart Tienen

    Tienen, 3300, Belgium

  • SRH Klinikum Karlsbad-Langensteinbach GmbH

    Karlsbad, 76307, Germany

  • Singapore General Hospital

    Singapore, 169608, Singapore

  • ZOL Genk

    Genk, 3600, Belgium

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