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New stent aims to unclog leg arteries safely

NCT ID NCT07010354

Disease control Sponsor: Bentley InnoMed GmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study is testing a covered stent called BeFlow to treat narrowed or blocked iliac arteries in the pelvis. Researchers will monitor 100 patients to see how well the stent restores blood flow and how safe it is. The goal is to improve walking ability and reduce pain caused by poor circulation.

What this could mean

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

Active substance
BeFlow iliac covered stent
What this could lead to
If successful, this stent could offer a reliable option to restore blood flow in blocked iliac arteries, reducing symptoms like leg pain and improving mobility.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. Risks include stent-related complications like re-blockage or blood clots.

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 100 people

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

Started

Aug 2025

Expected to finish

Dec 2031

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

Adult patients (≥ 18 years of age) suffering from stenotic lesions in the iliac arteries caused by arteriosclerosis or other pathologies that may be treated by stenting.

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: * Patients with an indication for permanent intraluminal placement in iliac arteries for restoring and improving the patency impaired by arteriosclerosis or other stenoses that may be treated by stenting according to the IFU of the BFI * Patient is capable and willing to sign an informed consent * Patients ≥18 years of age at the time of consent Exclusion Criteria: * Patients with any contraindication according to the IFU * Previous stenting of the target vessel

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Conditions

The condition(s) this trial relates to.

arterial occlusion

As listed by the trial registrant

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

Iliac artery occlusion Iliac artery stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 2 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

  • AZ Sint Blasius

    RECRUITING

    Dendermonde, 9200, Belgium

  • AZORG

    RECRUITING

    Aalst, 9300, Belgium

  • CHU de Liège

    RECRUITING

    Liège, 4000, Belgium

  • EOC - Ente Ospedaliero Cantonale

    RECRUITING

    Lugano, Canton Ticino, 6900, Switzerland

  • Ziekenhuis Oost-Limburg AV

    RECRUITING

    Genk, 3600, Belgium

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