Active not recruitingNAINTERVENTIONAL

ULTRA LONG: BioFreedom Ultra

This study, called ULTRA LONG: BioFreedom Ultra, is looking at a new type of medical device called a coronary stent. Stents are tiny tubes placed in narrowed heart arteries to keep them open. This particular stent, BioFreedom Ultra, has a special coating and is being tested in people who have heart artery disease and are also at a higher risk of bleeding. The main goal is to see if additional, larger sizes of this stent work just as well and are as safe as the smaller sizes that have already been approved for use. Researchers will be carefully monitoring participants to understand its effectiveness and safety.

At a glance

Status

Active not recruiting

Phase

Sponsor

Biosensors Europe SA

Enrolment target

Start

27 Feb 2024

Estimated completion

31 Aug 2026

Coronary Artery Disease High Bleeding Risk Patients

What is this study about?

When your heart arteries become narrowed, it can lead to various heart problems. Doctors often treat this by inserting a small tube, called a stent, to hold the artery open. This study is focusing on a specific type of stent called the BioFreedom Ultra. It's designed with a special coating and is being investigated for use in people who have heart artery disease and also have a higher chance of bleeding. Being at a 'high risk of bleeding' means that certain health conditions or medicines make it more likely for you to bleed easily or heavily.

The main purpose of this study is to look at different sizes of the BioFreedom Ultra stent. Some sizes of this stent are already approved, but the study wants to check if some new, larger sizes are just as safe and work just as effectively. This is important to ensure that doctors have a range of stent sizes that are reliable for different patients. By taking part, you would be helping doctors and researchers understand more about how this stent works for a wider group of people.

This is an 'open-label' study, which means both you and your doctor will know you are receiving the BioFreedom Ultra stent. The aim is to gather information on its safety and how well it performs over time in people with heart artery blockages who also face a higher risk of bleeding.

Key takeaways

The study is for people with heart artery disease and a high risk of bleeding.
It's testing additional sizes of the BioFreedom Ultra heart stent.
The main goal is to check the safety and effectiveness of these new sizes.
You must be at least 18 years old and expected to live for more than one year.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, and have a heart condition that doctors would normally treat with a stent. You must also be expected to live for more than one year.

A key part of this study is that you must be considered at 'high risk of bleeding'. Your doctor will check if you meet specific criteria for this, such as being over 75, having certain kidney problems, a history of bleeding, or needing specific blood-thinning medications long-term. You would also need to be suitable to take a specific type of blood-thinning medication (called DAPT) for about one month after the stent is put in.

Your doctor will discuss all the details with you, including explaining the specific reasons why you might be considered at high risk of bleeding, and if this study is right for your situation. You'll need to agree to take part by signing a consent form.

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?
Do you have heart artery disease that needs a stent?
Has your doctor told you that you are at a high risk of bleeding?
Are you able to take a specific blood-thinning medicine for about one month?
Do you expect to live for more than one year?
Are you willing to sign a consent form?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive the BioFreedom Ultra stent as part of your heart treatment. We don't have all the details about specific visits or assessments at this time, but typically, clinical trials involve regular check-ups with your study doctor and team. These might include blood tests, heart scans, and discussions about your health and any medications you are taking. You would be expected to take specific anti-platelet medication for about one month. The overall duration of your participation, including follow-up appointments, would be explained to you by the study team.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit could be receiving a new treatment option for your heart condition, particularly if you are at high risk of bleeding, where treatment choices can sometimes be more limited. However, as with any medical procedure, there are always risks associated with having a stent implanted, such as bleeding, infection, or issues with the stent itself. The study is designed to carefully monitor your health. You should know that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

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

Cardiovascular Institute Paris Sud (ICPS) L'Hôpital Privé Jacques Cartier
Verified postcode
Massy, France
Arnault Institute Tzanck
Verified postcode
Saint-Laurent-du-Var, France
Pôle Santé République
Verified postcode
Clermont-Ferrand, France
University Hospitals Birmingham (UHB)
Verified postcode
Birmingham, United Kingdom
Royal Blackburn Hospital
Verified postcode
Blackburn, United Kingdom
Hull University Teaching Hospitals (HUTH)
Verified postcode
Hull, United Kingdom
United Lincolnshire Hospitals (ULH)
Verified postcode
Lincoln, United Kingdom
The Grange University Hospital, Newport
Verified postcode
Newport, United Kingdom
Royal Albert Edward Infirmary
Verified postcode
Wigan, United Kingdom

Common questions

What is a stent?

A stent is a small, mesh tube that a doctor places in your heart artery to help keep it open and improve blood flow.

What does 'high bleeding risk' mean?

It means you have certain health conditions or take medicines that make you more likely to bleed easily or heavily.

Is the stent in this study new?

The BioFreedom Ultra stent is already approved in some sizes, but this study is looking at additional, larger sizes to see if they are just as safe and effective.

Will I know if I'm getting the study stent?

Yes, this is an 'open-label' study, so both you and your doctor will know you are receiving the BioFreedom Ultra stent.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it will not affect your regular medical care.