Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New balloon could open blocked leg arteries without surgery

NCT ID NCT07385573

Disease control Sponsor: KANDO Research 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 3 times

Summary

This trial tests a special balloon coated with a drug (paclitaxel) to treat blockages in the leg arteries caused by cholesterol buildup. The balloon is inflated to open the artery and release the drug to help keep it open. The study will include 200 people and check if the balloon works well and is safe over 12 months.

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 catheter
What this could lead to
If successful, this could provide a safe, effective way to open blocked leg arteries and reduce the need for repeat procedures.
What could go wrong
This is a single-arm study with no comparison group, so results may be less definitive. The device is already approved in Europe, so the trial is gathering additional real-world data rather than testing a new breakthrough.

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

About 200 people

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

Started

Jul 2026

Expected to finish

Jan 2032

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.

Ages

18 to 99 years

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 * Study participant is ≥ 18 years and ≤ 99 years old * Lesion(s) in the infrainguinal arteries: * Lesion above the knee (ATK): Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau) * Lesion below the knee (BTK): Target lesions involve arteries below the tibial plateau * RVD 2-7mm * De novo stenotic, restenotic post POBA, or occlusive lesion(s) * Target lesion must have angiographic evidence of ≥70% stenosis * Lesion length ≥ 3cm * Successful crossing of the target lesion with the guide wire * Successful predilatation, defined as residual stenosis \<50% Rutherford Class 2-5 * Study participant is able to provide consent and has signed and dated the informed consent form Exclusion criteria * Life expectancy ≤ 1 year * Study participant is currently participating in another investigational drug or device study that has not reached its primary endpoint yet. * Study participant is pregnant, planning to become pregnant, or father children during the course of the study. * Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion). * Prior bypass surgery of target vessel * Planned major amputation of the target limb * Thrombus in the target vessel * Known allergy to contrast media that cannot be adequately controlled with premedication * Study participant has a single target lesion that involves both ATK and BTK segments

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Drug coated balloon are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Drug coated balloon Peripheral arterial disease

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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, Belgium

  • AZORG

    RECRUITING

    Aalst, Belgium

    Contact Email: •••••@•••••

  • Imelda Ziekenhuis

    RECRUITING

    Bonheiden, Belgium

  • ZOL Genk

    RECRUITING

    Genk, Belgium

More trials for these conditions

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