RecruitingOBSERVATIONAL

Acotec DCB Post Market Clinical Follow-up

This study is checking how well a specific type of medical balloon works for people with peripheral artery disease (PAD). This condition affects blood flow to the legs, often causing pain when walking or even at rest. The balloons used in this study are coated with a special medicine and are designed to open up narrowed or blocked blood vessels in the legs. Doctors use these balloons during a procedure called angioplasty. This study is called a 'post-market clinical follow-up,' which means the balloon is already approved for use, and researchers want to gather more information on how it performs in a wider group of patients during routine care. It aims to confirm its safety and how effective it is in improving leg symptoms.

At a glance

Status

Recruiting

Sponsor

Acotec Scientific Co., Ltd

Enrolment target

3,000

Start

04 Jun 2020

Estimated completion

01 Mar 2027

Peripheral Artery Disease

What is this study about?

This study is investigating a new way to treat a common condition called peripheral artery disease (PAD). PAD happens when your arteries, which carry blood from your heart to your limbs, become narrowed or blocked, typically in the legs. This can lead to pain, especially when walking (a symptom called claudication), or in more severe cases, pain even at rest or sores that don't heal, known as critical limb ischaemia.

The treatment being looked at involves a special medical balloon, called a 'drug-coated balloon' (DCB). During a procedure called an angioplasty, this balloon is inserted into the narrowed artery and inflated to open it up. What makes this balloon special is that it's coated with a medicine that helps prevent the artery from narrowing again after the procedure. The goal is to improve blood flow, reduce pain, and prevent more serious problems.

This study is a 'post-market clinical follow-up'. This means the drug-coated balloons used in the study have already been approved for use, but doctors want to collect more information about how they work in everyday medical practice. They are looking at how safe the balloons are and how effectively they relieve symptoms and improve patients' lives in a real-world setting. This helps doctors better understand who benefits most from this treatment.

Key takeaways

This study evaluates a special drug-coated balloon for poor leg circulation.
It aims to check the safety and effectiveness of approved devices in routine care.
You must have significant leg artery blockages suitable for angioplasty.
Participation involves the procedure and follow-up appointments.
It could improve your leg symptoms but carries standard procedure risks.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have a specific type of peripheral artery disease (PAD). This means you have a significant narrowing or blockage in certain arteries in your legs that your doctor believes can be treated with these special balloons. Your leg pain should be affecting your daily life, ranging from pain when walking to more severe constant pain or even non-healing sores.

However, this study isn't suitable for everyone. For example, you can't join if your PAD is very mild or if you're already involved in another medical study that might affect the results. You also can't take part if you have allergies to the materials in the balloon, if doctors think you wouldn't be able to take the necessary medications, or if you have other serious health problems that might limit your life expectancy or make it hard to attend follow-up appointments. If you're pregnant or might become pregnant and aren't using contraception, you also cannot 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 18 years or older?
Do you have significant narrowing or blockages in your leg arteries?
Has your doctor said your leg arteries can be treated with angioplasty?
Can you take blood-thinning medications if prescribed?
Are you able to attend all required follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have a discussion with the study team and provide your written permission. You'll then undergo the standard angioplasty procedure where the special drug-coated balloon will be used to treat the affected artery in your leg. After the procedure, you'll have several follow-up visits and examinations as specified by the study plan. These appointments are important for the medical team to check on your recovery, how well the treatment is working, and to monitor for any side effects. The exact number and timing of appointments will be explained to you, but they are crucial for gathering all the necessary information for the study. You will also need to be able to take specific medications, such as blood thinners, as prescribed by your doctor.

Potential risks and benefits

Taking part in this study might offer a potential benefit of improved blood flow to your leg, which could reduce pain and improve your ability to walk, similar to the benefits of a standard angioplasty. It also contributes to medical knowledge, helping doctors understand more about this treatment. As with any medical procedure, there are potential risks, including those associated with angioplasty, such as bleeding, infection, or damage to the blood vessel. There's also the chance the balloon treatment might not work as expected or could lead to further complications. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (7)

Halle
Verified postcode
Halle, Germany· Recruiting
Eilenburg
Verified postcode
Eilenburg, Germany· Recruiting
Department of Angiology, University Hospital Leipzig,
Verified postcode
Leipzig, Germany· Recruiting
Elblandklinikum Radebeul
Verified postcode
Radebeul, Germany· Recruiting
Elblandklinikum Radebeul
Verified postcode
Riesa, Germany· Recruiting
REGIOMED Klinikum Sonneberg
Verified postcode
Sonneberg, Germany· Recruiting
KKH Torgau
Verified postcode
Torgau, Germany· Recruiting

Common questions

What is Peripheral Artery Disease (PAD)?

PAD is a condition where narrowed arteries reduce blood flow to your limbs, most commonly your legs. This can cause pain when walking or at rest.

What is a 'drug-coated balloon'?

It's a special medical balloon used in a procedure called angioplasty. It's coated with a medicine that helps keep the artery open after it's been widened.

Is this a new, unapproved treatment?

No, the balloons used in this study are already approved (they have a 'CE Mark'). This study is collecting more information about how they work in real-world patients.

Will I receive special treatment if I join?

You will receive the specific balloon treatment being studied during your angioplasty. Your care will follow your doctor's usual practice, but you'll have extra follow-up visits for the study.

Can I leave the study at any time?

Yes, you are free to leave the study at any point without it affecting your medical care.

How to find out more

Schmidt Andrej

andrej.schmidt@medizin.uni-leipzig.de +49-341-97 Official trial record

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