Active not recruitingOBSERVATIONAL

Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)

This study is for people with a condition where the arteries in their legs and feet become narrowed or blocked, making it hard for blood to flow. Doctors are evaluating a specific treatment called a 'drug-coated balloon' (DCB). This balloon is inserted into the narrowed artery and expanded, releasing a special medication to help keep the artery open. The study aims to see how safe and effective this treatment is for people with new blockages or those that have come back after previous treatments. It's a way to follow up on this balloon and see how patients who receive it are doing over time.

At a glance

Status

Active not recruiting

Sponsor

B. Braun Melsungen AG

Enrolment target

960

Start

01 May 2015

Estimated completion

01 Dec 2025

Peripheral Arterial Occlusive Disease

What is this study about?

This study is looking into a treatment for a condition called Peripheral Arterial Occlusive Disease. This is where the arteries that carry blood to your legs and feet become narrowed or blocked, often due to a build-up of fatty deposits. This can cause pain, especially when walking, and in more severe cases, can lead to serious problems.

The treatment being studied is a special type of angioplasty using a 'drug-coated balloon'. During this procedure, a thin tube with a balloon on the end is guided into the narrowed artery. When the balloon is inflated, it opens up the artery, and at the same time, it releases a medication called paclitaxel. This drug is designed to help prevent the artery from narrowing again after the procedure. The aim is to see how well this particular drug-coated balloon, called SeQuent® Please OTW, works in real-world use.

This study is designed to follow people who receive this treatment. It's important to understand that this is not a study where you might receive a placebo or a different type of treatment. Instead, it’s a way for doctors to gather more information about the performance and safety of this specific drug-coated balloon when used by itself to treat narrowed arteries in the legs and feet.

Key takeaways

The study helps doctors understand how well a special drug-coated balloon treats narrowed leg arteries.
It’s for people with circulation problems in their legs and feet.
You would receive the balloon treatment, and doctors would follow your progress for at least a year.
The goal is to see if the balloon is safe and effective in preventing arteries from re-narrowing.
The study focuses on the 'SeQuent® Please OTW' drug-coated balloon.

Who may be eligible?

To be able to take part in this study, you need to be an adult, at least 18 years old. You must have narrowed arteries in your legs and feet that your doctor believes can be treated with this special balloon. You should also be willing to have this specific drug-coated balloon treatment and understand what it involves.

The narrowed parts of your arteries (called 'lesions') have to be of a certain size and location for this study, specifically within your legs and feet, and not too short or too long. Your doctor will carefully check these details. It's also important that you can come back for follow-up appointments, including one about a year after your treatment.

If you have other serious health problems that make this procedure unsafe for you, or if your arteries are in a condition that cannot be treated in this way, you would not be able to participate. Your doctor will discuss all these points with you to see if this study is a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have narrowed arteries in your legs or feet that your doctor thinks can be treated by opening them up?
Are you willing to have a balloon treatment where a special drug is applied to open your artery?
Can you attend follow-up appointments for at least one year?
Are you able to understand the study and what is involved?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the drug-coated balloon treatment. There will be initial checks before the procedure, and then several follow-up appointments over a period of at least 12 months (one year). These follow-up visits are important so doctors can see how you are recovering and how well the treatment is working. During these visits, you might have examinations and possibly some scans to check the treated artery. You won't be given any new or experimental medications as part of the study; it's about observing the outcome of this specific balloon treatment.

Potential risks and benefits

Participating in this study means undergoing a medical procedure, so there are always potential risks involved, such as those associated with any angioplasty, including bleeding, infection, or damage to the artery. However, potential benefits include improved blood flow in your legs and feet, which could reduce pain and improve your quality of life. The study aims to gather more information on this specific treatment for future patients. You have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (1)

St. Gertrauden Krankenhaus
Verified postcode
Berlin, Germany

Common questions

What exactly is a 'drug-coated balloon'?

It's a special balloon used during an angioplasty procedure. When inflated inside a narrowed artery, it opens the artery and releases a medication to help prevent it from narrowing again.

Will I get a new drug or treatment if I join this study?

No, you will receive the SeQuent® Please OTW drug-coated balloon treatment, which is a specific type of balloon angioplasty. The study is about observing how well it works.

How long will I need to be involved in the study?

You will need to have follow-up visits for at least 12 months (one year) after your treatment to allow doctors to monitor your progress.

What kind of problem does this study address?

It addresses a condition called Peripheral Arterial Occlusive Disease, where arteries in your legs and feet become narrowed or blocked, affecting blood flow.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point, and this will not affect the medical care you receive.