RecruitingNAINTERVENTIONAL

Distrupt Stiffness Trial

This study focuses on Peripheral Arterial Disease (PAD), a condition where leg arteries become stiff and narrowed, often due to calcium buildup. This can cause leg pain when walking and affect wound healing. We're comparing two catheter-based treatments: one uses a special balloon (intravascular lithotripsy or IVL) that sends shockwaves to break up calcium, combined with a drug-coated balloon (DCB), and the other uses a standard balloon (POBA) with a DCB. The main goal is to understand how these treatments change the flexibility of the arteries, especially after calcium is broken down, to improve blood flow and patient outcomes. It's for people aged 18 to 85 with specific types of PAD.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Essen

Enrolment target

Start

01 Jul 2025

Estimated completion

20 Jun 2026

PAD - Peripheral Arterial Disease PAD

What is this study about?

Peripheral Arterial Disease (PAD) is a common condition where the arteries in your legs become narrow or blocked. This happens because of a build-up of fatty substances, calcium, and other materials on the artery walls, a process called atherosclerosis. Think of it like rust building up in a pipe, making it harder for water to flow through. When this happens in your legs, it reduces blood flow, which can cause pain, especially when you walk. This pain is known as 'intermittent claudication' and can really limit what you're able to do. In more serious cases, you might feel pain even when resting, or wounds on your feet and toes might struggle to heal because they're not getting enough oxygen and nutrients.

There are several factors that increase your risk of developing PAD, including common health issues like diabetes, high cholesterol, high blood pressure, being overweight, and smoking. Treatment for PAD often starts with lifestyle changes, like supervised exercise, medicines to thin the blood, and managing these risk factors. When these aren't enough, doctors can use 'keyhole' procedures, where a thin tube (catheter) is guided through your blood vessels to the affected area. There are different techniques, such as using a balloon to widen the artery, or a technique called 'lithoplasty' which uses shockwaves to break down hard calcium deposits in the artery walls.

This study, called 'Disrupt Stiffness Trial', wants to understand how effective these keyhole treatments are at improving the flexibility of stiff arteries. We are comparing two main approaches: one involves using a special balloon treatment that uses shockwaves (called Intravascular Lithotripsy, or IVL) to crack the calcium, followed by a drug-coated balloon (DCB). The other approach uses a standard balloon (POBA) first, also followed by a DCB. The aim is to see if breaking down the calcium with shockwaves truly helps the artery become more flexible and improves blood flow. We hope this will lead to better, longer-lasting results for people with PAD.

Key takeaways

Targets leg artery stiffness caused by calcium buildup.
Compares two keyhole treatments: shockwave balloon + drug balloon vs. regular balloon + drug balloon.
Aims to improve artery flexibility and blood flow.
May offer a new, more effective treatment option for PAD.
Participation involves a procedure and follow-up assessments.
Open to adults aged 18-85 with specific PAD characteristics.

Who may be eligible?

This study is looking for volunteers between 18 and 85 years old who have Peripheral Arterial Disease (PAD). To be considered, your PAD must have significant calcium buildup in specific arteries of your leg. You also need to be experiencing symptoms such as leg pain when walking, at rest, or have non-healing wounds, and your doctor must be planning to treat your condition with a keyhole procedure.

You would need to be able to come to all the planned follow-up appointments. Before you can join, you'll have a discussion with the study team and must provide your written agreement to take part.

However, you won't be able to join the study if you have issues that might interfere with the treatment or safety, such as certain blood clotting disorders, a recent heart attack or stroke (within the last month), or if you're not expected to live more than 12 months. Also, if you have certain allergies to common medications used in these procedures (like aspirin or heparin), or active infections (unless it's a wound on the treated leg), you would not be able to participate.

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 between 18 and 85 years old?
Have you been diagnosed with Peripheral Arterial Disease (PAD)?
Are your leg arteries severely calcified (hardened with calcium)?
Are you experiencing symptoms like leg pain or slow-healing wounds due to PAD?
Is your doctor planning a keyhole procedure for your PAD?
Are you able to attend all follow-up appointments for the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will undergo a keyhole procedure for your PAD, as described by your doctor. The specific type of balloon treatment you receive (either the shockwave balloon plus drug-coated balloon, or the standard balloon plus drug-coated balloon) will be chosen randomly, like flipping a coin. You won't know which one you're getting, and neither will your doctor during the procedure. After the procedure, the study team will monitor your progress. This will involve regular follow-up visits and tests to check your artery flexibility and blood flow, likely using ultrasound scans. You'll also need to continue with any standard medications prescribed by your doctor. The total duration of your participation in the study, including all follow-up appointments, will be explained in detail by the study team.

Potential risks and benefits

Taking part in this study could potentially offer you the benefit of receiving a new and potentially effective treatment for your PAD, which aims to improve artery flexibility and blood flow. However, as with any medical procedure, there are potential risks. These include the usual risks associated with keyhole treatments for PAD, such as bruising, bleeding, infection, or damage to the artery. The study team will explain these risks in detail. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

West German Heart and Vascular Center, Clinic for Cardiology and Vascular Medicine, Universtiy Hospital Essen
Verified postcode
Essen, Germany· Not yet recruiting
University of Duisburg-Essen
Verified postcode
Essen, Germany· Recruiting

Common questions

What is Peripheral Arterial Disease (PAD)?

PAD is a condition where arteries in your legs narrow, usually due to a build-up of calcium and fats, reducing blood flow and causing pain.

What is 'Intravascular Lithotripsy (IVL)'?

IVL is a special balloon treatment that uses shockwaves to gently break up hard calcium deposits in your artery walls, making them more flexible.

Why is artery flexibility important?

More flexible arteries allow blood to flow more easily, which can relieve pain, help wounds heal, and improve your overall health.

Will I know which treatment I'm getting?

No, the treatment type will be chosen randomly, and neither you nor your doctor will know during the procedure, to ensure fair comparison.

What happens after the treatment?

You'll have follow-up visits with the study team, including scans, to monitor your recovery and how your arteries are responding.

How to find out more

Christos Rammos, Prof. Dr. med.

christos.rammos@uk-essen.de 0201-723-4801 Official trial record

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