RecruitingOBSERVATIONAL

eUltra 10k - Biofreedom Ultra

This study, called eUltra 10k, is looking at how a medical device called the BioFreedom Ultra stent works for patients in their daily lives. A stent is a tiny mesh tube doctors use to open up blocked or narrowed blood vessels, often in the heart. This particular study isn't about testing a new treatment; instead, it's about carefully watching and collecting information on patients who have already received the BioFreedom Ultra stent as part of their regular medical care. This helps researchers understand how the stent performs for many different people in various medical settings. It’s part of an ongoing process to ensure medical devices are safe and effective after they become available for general use.

At a glance

Status

Recruiting

Sponsor

Biosensors Europe SA

Enrolment target

10,000

Start

15 Jun 2023

Estimated completion

30 Mar 2029

Post Market Clinical Follow up (PMCF)

What is this study about?

Imagine your doctor performs a procedure to place a small tube, called a stent, inside a blood vessel to help keep it open. The eUltra 10k study is a large-scale project that wants to understand how one specific type of stent, called the BioFreedom Ultra, works for people in their everyday lives, outside of a strict research setting. This type of study is known as a 'registry,' which simply means it's a way to collect information from many different patients over time.

This isn't a study where you would be given a new or experimental treatment. Instead, if you've already received a BioFreedom Ultra stent as part of your standard medical care, your information might be included. The goal is to see how the stent performs across a wide range of patients and hospitals, giving doctors and researchers a much clearer picture of its effectiveness and safety in the 'real world.'

This kind of information is really important because it helps ensure that medical devices continue to be safe and work well for many years after they've been approved for use. By observing how thousands of patients are doing with the stent, medical professionals can learn valuable lessons that benefit future patients.

Key takeaways

This study observes how the BioFreedom Ultra stent works in real patients.
It's for people who have already received this specific stent.
Participation mainly involves a one-year follow-up by phone or clinic visit.
The study helps improve understanding of medical devices for future patients.
There are no extra medical procedures or risks involved in participating in the study.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you would need to be at least 18 years old and have already received the BioFreedom Ultra stent as part of your regular medical treatment. It's important that you understand what the study involves and are happy to give your permission by signing a consent form.

There are certain situations where someone wouldn't be able to join. For example, if you are under the age of 18, or if you are pregnant or breastfeeding, you wouldn't be able to take part. Also, if a court or administrative decision has limited your freedom or decision-making ability, you would not be included in the study. Essentially, the study wants to make sure participants are adults who can freely and willingly agree to participate.

Quick self-check

Are you 18 years old or older?
Have you recently received a BioFreedom Ultra stent?
Are you able to give your informed consent (permission) to participate?
Are you not pregnant or breastfeeding?
Are you not under any legal guardianship or judicial restriction?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you are asked to be part of this study, it means you've already had the BioFreedom Ultra stent placed during a procedure. Your participation would mainly involve allowing the study team to collect information about your health and how you're doing with the stent. The main way they'll get this information is through a phone call about one year after your stent procedure.

Sometimes, instead of a phone call, this check-up might happen during a regular clinic visit you already have scheduled. The study isn't asking you to take any new medication or have extra tests. It's about observing your health journey after your stent procedure, not changing your medical care. The data collection for each patient will last for about one year.

Potential risks and benefits

Since this study is simply observing patients who have already received the BioFreedom Ultra stent as part of their standard care, there are no additional medical risks directly linked to participating in the study itself. You won't be given any new treatments or extra procedures for the study. The main benefit is that your information will help doctors and researchers better understand how the stent works, which can ultimately improve care for many patients in the future. You always have the right to withdraw from the study at any time without it affecting your medical care.

Locations (10)

Krankenhaus Barmherzige Brüder
Eisenstadt, Austria· Recruiting
Clinique Des Domes Psr
Clermont-Ferrand, France· Recruiting
Klinikum Lippe
Detmold, Germany· Recruiting
Hospital Marques Valdecilla
Santander, Spain· Recruiting
University and Hospital Fribourg
Fribourg, Switzerland· Recruiting
Universitäres Herzzentrum
Zurich, Switzerland· Recruiting
Military hospital
Tunis, Tunisia· Recruiting
Al Qassimi Hospital
Sharjah city, United Arab Emirates· Recruiting
Royal Bournemouth hospital
Bournemouth, United Kingdom· Recruiting
Golden Jubilee National Hospital
Glasgow, United Kingdom· Recruiting

Common questions

What is a 'stent'?

A stent is a tiny mesh tube that doctors place inside a blood vessel to help keep it open, improving blood flow.

What does 'Post Market Clinical Follow-up' mean?

It means the study is collecting information on a medical device (like the stent) after it has already been approved and is being used by patients in hospitals.

Will I get a new treatment in this study?

No, this study is about collecting information on patients who have already received the BioFreedom Ultra stent as part of their normal medical care.

How long will I be involved in the study?

For each patient, the study involves a follow-up about one year after the stent was placed, usually with a phone call.

Can I leave the study if I change my mind?

Yes, you are always free to withdraw from the study at any time without it affecting your medical care.

How to find out more

Calvin Bahr, MS

c.bahr@biosensors.com +41 21 804 80 24 Official trial record

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