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Balloon coated with drug could keep leg arteries open longer

NCT ID NCT02460042

Disease control Sponsor: B. Braun Melsungen AG 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study is testing a special balloon catheter coated with the drug paclitaxel to treat blocked arteries in the legs, a condition called peripheral artery disease. The balloon is inflated inside the artery to open it up, and the drug helps prevent the artery from narrowing again. Researchers are looking at how well this treatment works and how safe it is in a large group of patients with different types of blockages.

What this could mean

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

Active substance
a paclitaxel-coated balloon catheter used during angioplasty to open blocked leg arteries
What this could lead to
If successful, this could provide a more effective way to treat peripheral artery disease, reducing the need for repeat procedures and improving blood flow in the legs.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. Risks include vessel damage, re-narrowing, or allergic reactions to the drug or balloon material.

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

960 people

The number who actually took part.

Started

May 2015

Finished

Nov 2025

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 peripheral artery occlusive disease (PAOD)

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 (patient): * Willingness to treat the target lesion according to the DCB only concept * Patients in Rutherford classes 2 through 5 * Patients eligible for peripheral revascularization by means of Percutaneous Transluminal Angioplasty (PTA) * Patients must be 18 years of age * Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol * Patients must agree to undergo at least the 12-month clinical follow-up * Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of the paclitaxel-eluting PTA-balloon catheter or other suitable devices. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document. Inclusion Criteria (lesion): * Peripheral lesions in peripheral arteries above and below the knee with reference vessel diameters between 1.5 and 8.0 mm, lesion lengths ≥ 2 cm and ≤ 27 cm as angiographically documented\* * Diameter stenosis pre-procedure must be 70% * Target lesion above and below the knee * Vessels must have adequate runoff with at least one vessel to the foot. \*Lesions separated by less than 2 cm are considered as one lesion Exclusion Criteria (all comers): * Patient not suitable for revascularization by interventional means

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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 occlusive disease

Contacts and locations

Locations

  • St. Gertrauden Krankenhaus

    Berlin, 10713, Germany

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