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European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.

This study, called a registry, is tracking how well a special balloon, called LUMINOR©, works to open up narrowed or blocked arteries in the upper legs (superficial femoral and popliteal arteries). These blockages are often caused by Peripheral Arterial Disease (PAD), which means poor circulation in the legs. Doctors use this balloon method, called angioplasty, to improve blood flow. The LUMINOR© balloon has a medicine on it (Paclitaxel) that helps stop the artery from narrowing again. The study will follow patients for 5 years to see how safe, effective, and cost-efficient this treatment is, especially for harder-to-treat blockages.

At a glance

Status
Recruiting
Sponsor
iVascular S.L.U.
Enrolment target
500
Start
18 Jan 2021
Estimated completion
30 Jun 2026

What is this study about?

Imagine the pipes in your house getting clogged up with limescale; something similar can happen in your legs with blood vessels. When arteries in your legs become narrow or blocked due to a build-up of fatty deposits, it's called Peripheral Arterial Disease (PAD). This can lead to pain when walking, especially in your calves (claudication), and in more severe cases, wounds that don't heal, or even tissue damage.

One common treatment to open up these blocked arteries is called angioplasty. This involves inserting a tiny balloon into the blocked artery and inflating it to push the blockage aside. In this study, doctors are using a special type of balloon called a LUMINOR© drug-eluting balloon (DEB). This balloon is coated with a medicine (Paclitaxel) that helps prevent the artery from narrowing again after it's been opened.

This study is a 'registry,' which means it collects information on how the LUMINOR© balloon works in many different real-world situations, rather than in a highly controlled trial. The main goal is to understand how safe and effective this particular balloon is for people with PAD over an extended period of 5 years. They are also looking at its cost-effectiveness and how well it works for different types of blockages, including those that are new or have come back, and those that are heavily stiffened or very long.

Key takeaways

  • This study evaluates a special balloon for blocked leg arteries.
  • It helps patients with poor circulation in their legs.
  • The balloon has medicine to keep the artery open.
  • Patients will be followed for 5 years to check the treatment's success.
  • It's collecting real-world information on this treatment.
  • The study aims to understand safety, effectiveness, and cost.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have problems with blood flow in your legs (Peripheral Arterial Disease), causing symptoms ranging from pain when walking to more severe issues like ulcers. The blockages in your upper leg arteries must be quite significant (at least 70% blocked) or completely closed off.

Doctors will need to be able to successfully guide a wire past the blockage and perform an initial balloon widening of the artery. It's also important that you have at least one clear blood vessel flowing down to your ankle. You also need to be willing to commit to 5 years of follow-up appointments.

However, you cannot join if you are pregnant, breastfeeding, planning to become pregnant, or if you are a man planning to father children. You also can't participate if your doctors believe you have less than a year to live, or if you are already in another medical study involving a new drug or device, or if the LUMINOR© balloon is not suitable for you according to its instructions.

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.

  1. Are you 18 years old or older?
  2. Do you have poor circulation in your legs causing pain or other symptoms?
  3. Are you able to attend follow-up appointments for 5 years?
  4. Are you *not* pregnant, breastfeeding, or planning a pregnancy (for men, not planning to father children)?
  5. Are you *not* currently in another study testing a new drug or device?
Answer every question to see your result.

What does participation involve?

If you join this study, you will have a procedure to open your blocked leg artery using the LUMINOR© drug-eluting balloon. After the procedure, you will have regular check-ups and assessments over a period of 5 years. These follow-up appointments are crucial to track how well the artery stays open and how your symptoms progress over time. The exact number and type of visits will be explained by the study team, but they will likely involve consultations and imaging tests to monitor your blood vessels.

Potential risks and benefits

Participating in this study might offer you a benefit by potentially improving blood flow to your leg and reducing your symptoms, using a treatment that is being carefully monitored. However, as with any medical procedure, there are risks, such as bleeding, infection, damage to the artery, or other complications. The medicine on the balloon also carries its own risks, which your doctor will discuss with you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

  • Centre Hospitalier Universitaire Pellegrin
    Verified postcode
    Bordeaux, France· Recruiting
  • Clinique Générale Annecy
    Verified postcode
    Annecy, France· Recruiting
  • Clinique Rhône Durance
    Verified postcode
    Avignon, France· Recruiting
  • Centre hospitalier de la Côte Basque
    Verified postcode
    Bayonne, France· Recruiting
  • Polyclinic Bordeaux Nord Aquitaine
    Verified postcode
    Bordeaux, France· Recruiting
  • Hôpital Ambroise Paré
    Verified postcode
    Boulogne-Billancourt, France· Recruiting
  • Centre Hospitalier Régional Universitaire Morvan de Brest
    Verified postcode
    Brest, France· Recruiting
  • CHRU Lille
    Verified postcode
    Lille, France· Recruiting
  • Clinic Mutualiste Porte de L'Orient
    Verified postcode
    Lorient, France· Recruiting
  • CHU Timone Marseille
    Verified postcode
    Marseille, France· Recruiting
  • CH Layné
    Verified postcode
    Mont-de-Marsan, France· Recruiting
  • Hôpital Privé des Franciscaines
    Verified postcode
    Nîmes, France· Recruiting

Common questions

What is Peripheral Arterial Disease (PAD)?

PAD is when your leg arteries become narrowed or blocked, reducing blood flow and causing pain or other problems.

What is an angioplasty?

It's a procedure where a balloon is used to open up a blocked artery and improve blood flow.

What does 'drug-eluting balloon' mean?

It's a special balloon coated with medicine that helps prevent the artery from closing up again after it's been opened.

How long will I be followed in this study?

You will be followed for 5 years after your procedure to see how you are doing.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "European All-comers' Multicentric Prospective REGISTRY on LU…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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