RecruitingOBSERVATIONAL

Resorbable Magnesium Scaffolds Registry

This study is a registry, which means it collects information about how certain heart devices, called Resorbable Magnesium Scaffolds (RMS), are used in real people. These devices, specifically Magmaris and Freesolve, are for individuals with coronary artery disease, a condition where the blood vessels supplying the heart become narrowed. The registry aims to understand how well these devices work and how safe they are in a day-to-day setting, just as they are meant to be used. It follows common European heart health guidelines and includes anyone who would normally receive these devices according to their instructions. It's a way for doctors to learn more about these new treatments in a straightforward way, helping to improve care for heart patients.

At a glance

Status

Recruiting

Sponsor

Biotronik AG

Enrolment target

1,106

Start

18 Nov 2020

Estimated completion

01 May 2030

Coronary Artery Disease

What is this study about?

This study is like a watchful eye on new heart treatments. It's called a 'registry,' which means it collects information about how certain devices, called Resorbable Magnesium Scaffolds (RMS), are actually used in people with coronary artery disease. Coronary artery disease is a common condition where the blood vessels that deliver blood to your heart become narrowed, often due to a build-up of fatty deposits.

The specific devices being looked at here are Magmaris and Freesolve. These are special types of supports designed to help keep your arteries open and then, over time, they dissolve in your body. The goal of this study is to see how well these dissolving supports work and if they are safe when used in everyday medical practice, outside of a strictly controlled research setting. It means doctors are observing how patients who receive these devices are doing in the real world.

By collecting this information, doctors and researchers can learn a lot about these new devices. This helps them understand if the devices are performing as expected and if there are any common issues. This kind of study is important because it helps improve the way we treat heart disease, ensuring that new treatments are both effective and safe for patients like you.

Key takeaways

This study collects real-world data on new dissolving heart supports (Magmaris, Freesolve).
It aims to understand how well these devices work and how safe they are for patients with coronary artery disease.
Participation involves simply allowing your medical information from routine care to be collected.
There are no extra tests, visits, or treatments involved beyond your standard medical care.
Your contribution helps improve our understanding and care for heart conditions.

Who may be eligible?

This study is for adults aged 18 and over who have been diagnosed with coronary artery disease. There are no upper age limits, so elderly patients are also welcome to be included.

To be considered for this study, you would typically be a patient who your doctor believes would benefit from and receive one of the specific dissolving heart supports (Magmaris or Freesolve) as part of your standard treatment.

There aren't many strict exclusion criteria beyond what your doctor would normally consider when deciding if these devices are right for you. Generally, if your doctor is already planning to use one of these devices for your heart condition, you might be included in this registry.

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?
Have you been diagnosed with coronary artery disease?
Is your doctor planning to treat your condition using a Magmaris or Freesolve dissolving heart support?
Are you able to attend your regular follow-up appointments as advised by your doctor?

Answer every question to see your result.

What does participation involve?

If you are included in this registry, it largely involves your doctors collecting information about your treatment and progress as part of your regular medical care. You wouldn't be asked to do anything extra that isn't already part of your usual follow-up schedule after receiving a heart device.

This means your participation would involve attending your routine doctor appointments and any planned check-ups related to your heart condition and the device. Your doctors would then record information about how the device is working and how you are feeling, following their normal procedures. There are no additional study visits, medications, or specific assessments beyond what your doctor would typically recommend for your ongoing care. The total duration of your involvement would depend on how long your doctors normally follow patients after they receive such a device.

Potential risks and benefits

Participating in this registry primarily means that information about your treatment with a Resorbable Magnesium Scaffold will be collected and studied by doctors. A potential benefit is that your experience, along with many others, will help medical professionals understand these devices better, potentially improving future heart care for everyone. Since you would be receiving this treatment as part of your standard care, there are no extra medical risks associated with *participating in the registry itself*, beyond the usual risks of the heart procedure and the device, which your doctor would discuss with you. You have the right to withdraw your consent for your data to be used in the registry at any time, without affecting your medical care.

Locations (13)

Cairns Hospital
Verified postcode
Cairns, Australia· Completed
Heart Center Segeberger Kliniken
Verified postcode
Bad Segeberg, Germany· Recruiting
Krankenhaus Buchholz
Verified postcode
Buchholz, Germany· Completed
Klinikum Westfalen, Knappschaft KH
Verified postcode
Dortmund, Germany· Completed
Klinikum Herford
Verified postcode
Herford, Germany· Completed
Herz-und Gefäßzentrum Oberallgäu-Kempten
Verified postcode
Kempten, Germany· Completed
Centro Cardiologico Monzino
Verified postcode
Milan, Italy· Recruiting
Daugavpils Regional Hospital
Verified postcode
Daugavpils, Latvia· Completed
1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie
Verified postcode
Lublin, Poland· Recruiting
SUSCCH Banska Bystrica
Verified postcode
Banská Bystrica, Slovakia· Completed
Lindenhofspital
Verified postcode
Bern, Switzerland· Recruiting
Centre Hospitalier Universitaire Vaudois
Verified postcode
Lausanne, Switzerland· Recruiting

Common questions

What is coronary artery disease?

It's a condition where the blood vessels supplying your heart become narrowed, reducing blood flow.

What are Resorbable Magnesium Scaffolds?

They are special tube-like devices that help keep heart arteries open, and then slowly dissolve safely in your body over time.

Will I get extra tests if I join?

No, you won't have any extra tests or appointments beyond your usual medical care for your heart condition.

Are Magmaris and Freesolve common treatments?

They are specific types of the dissolving heart supports that doctors are observing in this study.

Can I decide not to be part of the registry?

Yes, you can choose not to have your information included, and it won't affect your medical treatment.

How to find out more

Marina Gattiglio, Dr.

marina.gattiglio@teleflex.com +41754295843 Official trial record

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