Active not recruitingOBSERVATIONAL

BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry

This study, called BIOFLOW-VIII, is checking a new type of heart stent called Orsiro Mission. This stent is used for people who have narrowed heart arteries (coronary artery disease) and need a procedure to open them up. The study wants to see how safe and effective this particular stent is when used in day-to-day medical practice. It's not comparing it to other treatments, but rather observing how it performs in a wide range of patients. Doctors will follow up with patients who receive this stent over several years to see how they are doing. This helps ensure that the stent is a good and reliable option for people needing this kind of heart treatment.

At a glance

Status

Active not recruiting

Sponsor

Biotronik AG

Enrolment target

872

Start

25 Sep 2020

Estimated completion

19 Feb 2027

Coronary Artery Disease Myocardial Ischemia

What is this study about?

When your heart arteries become narrowed or blocked, it's often called coronary artery disease. This can lead to chest pain, breathlessness, or sometimes a heart attack. One common treatment involves a procedure where a tiny tube, called a stent, is placed in the artery to hold it open. The Orsiro Mission stent is a new type of stent which is coated with a medicine (that's what 'Drug Eluting Stent' means) to prevent the artery from narrowing again.

This BIOFLOW-VIII study isn't a typical trial where people are given different treatments by chance. Instead, it's like a large-scale observation. Doctors are enrolling patients across many hospitals in France who are already chosen to receive the Orsiro Mission stent as part of their regular care. The main goal is to collect real-world information on how well this specific stent works and how safe it is for a variety of patients, including those with different health conditions, just as they are treated in everyday hospital settings.

The information gathered from this study will help healthcare professionals better understand the long-term safety and effectiveness of the Orsiro Mission stent. It's important to collect this kind of information after a medical device has been approved for use, as it gives a clearer picture of how it performs in a broad group of patients over many years. This helps ensure that patients are getting the best and safest possible care for their heart condition.

Key takeaways

This study observes a specific heart stent, the Orsiro Mission, in people with heart artery disease.
It aims to understand the stent's safety and effectiveness in real-world patient care.
Participation involves receiving the stent as planned and having follow-up check-ups for up to 5 years.
Many follow-ups can be done over the phone.
The study helps provide long-term information about this type of stent.

Who may be eligible?

To be part of this study, you would need to be an adult, at least 18 years old, and have problems with your heart arteries that your doctor plans to treat with the Orsiro Mission stent. This includes situations where you might have chest pain or other symptoms, or even if you have heart artery issues that haven't caused noticeable symptoms yet (this is called 'silent ischemia'). Most importantly, you need to understand and agree to have your health information collected for the study.

You also need to be someone who lives in a stable location and is willing and able to come back for all the planned follow-up appointments. These check-ups are crucial for the study to gather complete information on how you're doing over time.

There are some reasons why you wouldn't be able to join. For example, if you are pregnant, or if you have a known severe allergy to certain medications commonly used during or after a stent procedure, or to the materials the stent itself is made from. This is to ensure your safety and that you can receive all necessary medications and follow-up care without serious risks.

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.

Am I at least 18 years old?
Does my doctor plan to treat my heart artery problem with an Orsiro Mission stent?
Am I willing to have my health information used in the study?
Can I attend or participate in follow-up check-ups for approximately 5 years (some by phone)?
Do I have any severe allergies to heart medications or device materials that would prevent using the stent or necessary drugs?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the Orsiro Mission stent as part of your standard heart procedure. After your procedure, doctors will keep in touch to see how you are doing over time. This involves check-ups at 6 months, 12 months, 3 years (36 months), and 5 years (60 months) after your stent was placed. Importantly, many of these follow-up check-ups can be done over the phone, making them more convenient for you. The study aims to follow patients for a total of five years to understand the long-term effects of the stent.

Potential risks and benefits

This study does not involve new or experimental treatments; it's observing a stent already in use. The main benefit is that your health data will contribute to a better understanding of how the Orsiro Mission stent works in many patients, potentially improving care for others in the future. As with any medical procedure, risks associated with receiving a heart stent include complications from the procedure itself. Participation also means sharing your health information for analysis, though it will be kept private. You are free to withdraw from the study at any time without affecting your medical care.

Locations (41)

Clinique Esquirol Saint Hilaire
Verified postcode
Agen, France
Clinique Axium
Verified postcode
Aix-en-Provence, France
CH Antibes
Verified postcode
Antibes, France
CH de Bastia
Verified postcode
Bastia, France
GCS de cardiologie
Verified postcode
Bayonne, France
Clinique Convert
Verified postcode
Bourg-en-Bresse, France
Hôpital Privé Saint Martin
Verified postcode
Caen, France
CHU de Cermont Ferrand
Verified postcode
Clermont-Ferrand, France
CH Sud Francilien
Verified postcode
Corbeil-Essonnes, France
CHU Henri Mondor
Verified postcode
Créteil, France
Centre de cardiologie d'Evecquemont
Verified postcode
Évecquemont, France
Clinique Mutualiste
Verified postcode
Grenoble, France

Common questions

What is the Orsiro Mission stent?

It's a small tube placed in a heart artery to keep it open, coated with medicine to help prevent it from narrowing again.

Why is this study being done?

It's to observe how safe and effective the Orsiro Mission stent is for a wide range of patients in everyday medical practice over several years.

Will I get a different treatment if I join?

No, you will receive the Orsiro Mission stent, which your doctor has already decided is the right treatment for you.

How long will I be followed up for?

You will have check-ups for up to 5 years after your stent procedure, some of which can be by phone.

What if I change my mind about participating?

You can decide to stop participating at any time without it affecting your medical care.