RecruitingOBSERVATIONAL

Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

This study, called CALCIO, is for people with a serious leg condition called chronic limb-threatening ischemia (CLTI). This condition happens when poor blood flow causes wounds that don't heal, and if left untreated, can lead to amputation. The study is observing a new treatment called intravascular lithotripsy (IVL), using the Shockwave IVL system. This treatment uses sound waves to break up calcium build-up in blood vessels in the legs, helping to restore blood flow. The main goal is to see if this treatment helps wounds heal and prevents the need for amputation. We also want to understand if it quickly improves blood flow and if it's safe and helps improve patients' quality of life.

At a glance

Status

Recruiting

Sponsor

Cardiovascular and Interventional Radiological Society of Europe

Enrolment target

400

Start

15 Jul 2024

Estimated completion

31 Dec 2028

Chronic Limb-Threatening Ischemia

What is this study about?

This study, called CALCIO, is designed to understand how well a new treatment works for a serious leg condition called chronic limb-threatening ischemia (CLTI). This condition occurs when blood flow to your legs is severely reduced, often due to hardened arteries. This can cause painful sores that don't heal, and in severe cases, might lead to the need for amputation if not treated effectively.

The new treatment being looked at is called intravascular lithotripsy (IVL), using a special device called the Shockwave IVL system. Think of it like using mini sound waves or vibrations inside your blood vessels. These sound waves can gently break up hard calcium deposits that are blocking your arteries, helping to open them up and improve blood flow to your legs. We want to see if this helps your wounds heal and reduces the risk of needing an amputation.

By carefully watching how patients respond to this treatment in real-world situations, we hope to learn more about its benefits. We'll be checking how immediately successful it is at clearing blockages, if it's safe, and whether it makes a positive difference to how you feel and your overall quality of life.

Key takeaways

This study looks at a treatment for serious leg artery blockages.
It uses sound waves (IVL) to break up calcium in leg arteries.
The main goals are to improve wound healing and prevent amputation.
It's an observational study, meaning researchers watch how the treatment works in real life.
Participation is voluntary and will not affect your regular medical care.

Who may be eligible?

To be considered for this study, you would need to have chronic limb-threatening ischemia (CLTI), which is a serious condition where your leg has problems because of poor blood flow. Specifically, doctors would need to see hardened, calcified blockages in your leg arteries (either in the thigh/knee area or lower leg arteries) on an X-ray or scan.

The treatment used in this study involves the Shockwave Medical IVL System, so you must be receiving this specific treatment. You also need to be 18 years old or older.

There are a few reasons why you might not be able to join. For example, if you're under 18, pregnant, or unable to give your full consent (agreement) to participate. Also, if you've had another procedure on the same leg arteries within the last four weeks, you wouldn't be able to join this particular study.

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.

Do I have a serious condition affecting my leg from poor blood flow (CLTI)?
Do X-rays or scans show hardened calcium blockages in my leg arteries?
Will I be receiving the Shockwave Medical IVL treatment for my condition?
Am I 18 years old or older?
Am I not pregnant and haven't had a procedure on the same leg arteries in the last 4 weeks?

Answer every question to see your result.

What does participation involve?

This is an observational study, which means doctors will be carefully watching and collecting information about your usual care if you are receiving the Shockwave IVL treatment. There aren't any extra medications given as part of this study. You will have your regular medical appointments and assessments, and the study will gather data from those. The specific number of visits and exact duration would depend on your individual treatment plan and how your doctors monitor your condition over time, but generally, this involves follow-up appointments where your doctors assess your wounds, blood flow, and general health.

Potential risks and benefits

Participating in this study means your doctors will be closely observing how the Shockwave IVL treatment works for you. Potential benefits include the possibility of improved blood flow to your leg, which could help your wounds heal and reduce the risk of amputation. However, like any medical procedure, there are always potential risks; your doctor will discuss these with you. This study aims to gather more information about both the effectiveness and safety of this treatment in a real-world setting. You are free to withdraw from the study at any time without affecting your medical care.

Locations (39)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Krankenhaus der Barmherzigen Brüder
Verified postcode
Eisenstadt, Austria· Recruiting
Medizinische Universität Graz
Verified postcode
Graz, Austria· Recruiting
Krankenhaus Barmherzige Brüder Linz
Verified postcode
Linz, Austria· Recruiting
Klinik Hietzing
Verified postcode
Vienna, Austria· Recruiting
Klinik Florisdorf
Verified postcode
Vienna, Austria· Recruiting
Hôpital Sacré Coeur de Montréal
Verified postcode
Montreal, Canada· Recruiting
CHU François Mitterrand
Verified postcode
Dijon, France· Recruiting
Institute Mutualiste Montsouris
Verified postcode
Paris, France· Recruiting
Rhéna Clinique de Strasbourg
Verified postcode
Strasbourg, France· Recruiting
Universitätsklinikum Köln
Verified postcode
Cologne, Germany· Recruiting
Universitätsmedizin Essen
Verified postcode
Essen, Germany· Recruiting
KRH Klinikum Robert Koch Gehrden
Verified postcode
Hanover, Germany· Recruiting

Common questions

What is chronic limb-threatening ischemia (CLTI)?

CLTI is a serious condition where blood flow to your leg is severely reduced, often causing non-healing wounds and potentially leading to amputation.

What is intravascular lithotripsy (IVL)?

IVL is a treatment that uses special sound waves to break up hard calcium deposits in your blood vessels, aiming to improve blood flow.

Is this a new medicine?

No, this study is about a medical device that uses sound waves, not a new medicine.

Will I get extra treatment if I join?

No, this study observes patients who are already receiving the Shockwave IVL treatment as part of their standard care. It doesn't involve any extra treatments.

Do I have to take part in this study?

No, taking part is completely voluntary. Your decision will not affect your medical care.

How to find out more

Claire Poulet, PhD

calcio@cirse.org +41 79 385 16 78 Official trial record

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