RecruitingOBSERVATIONAL

Coroflex® ISAR NEO PMCF Study

This study is looking at a special heart stent called Coroflex® ISAR NEO. This stent is used for people who have blocked arteries in their heart, a condition known as Coronary Artery Disease. The main goal is to check and confirm that this stent is both safe and effective when used in real-world patients during their normal heart treatments. This is important for meeting the latest UK and European health regulations for medical devices. It’s an ongoing check-up on a product already in use, making sure it continues to perform as expected for patients.

At a glance

Status

Recruiting

Sponsor

Fundación EPIC

Enrolment target

3,000

Start

04 Aug 2023

Estimated completion

01 Feb 2027

Coronary Artery Disease (CAD)Ischemic Heart Disease

What is this study about?

This study is focused on a medical device called the Coroflex® ISAR NEO coronary stent system. A stent is a tiny mesh tube that doctors place in a narrowed or blocked artery to help keep it open. This particular stent slowly releases a medicine called Sirolimus, which helps prevent the artery from narrowing again.

The main purpose of this study is to closely watch how well this stent works and how safe it is for patients in real-life situations. This is a very common type of study for medical devices that are already approved and being used. It's a way for regulators (like those who set health standards in the UK and Europe) to make sure products continue to perform as expected after they've been on the market for a while. Think of it as a continuous quality check to ensure patient safety and the stent's effectiveness.

Doctors taking part in this study will follow patients who receive the Coroflex® ISAR NEO stent as part of their normal heart treatment. They'll collect information on how these patients are doing over time. This helps build a picture of the stent's performance in a wide range of people, confirming it works well and is safe for everyone it's intended to help.

Key takeaways

This study focuses on a specific heart stent called Coroflex® ISAR NEO.
It's for people with blocked heart arteries.
The main goal is to confirm the stent's safety and effectiveness in real-world patients.
The stent is already in use; this is a 'post-market' check-up.
Participation involves receiving the stent as part of your planned treatment and follow-up.
You can always withdraw from the study at any time.

Who may be eligible?

To join this study, you would typically be an adult aged 18 or over who needs a heart stent because of blocked heart arteries. Your doctor would have already decided that a procedure to place a stent (called Percutaneous Coronary Intervention, or PCI) is the right treatment for you, following standard heart care guidelines.

However, there are also reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, you wouldn't be able to take part. Also, if you have certain severe heart problems, an allergy to the stent materials or medicines used, or if you're already in another clinical study, you would likely not be eligible.

It’s also important that you don't have a very short life expectancy or conditions that would make taking anti-clotting medications unsafe for you. If you're unsure, your heart doctor can help you understand if this study might be an option for you.

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?
Has your heart doctor recommended a stent procedure for your blocked heart arteries?
Are you NOT pregnant or breastfeeding?
Do you NOT have severe allergies to the stent's materials or medicines used?
Are you NOT already taking part in another medical study?

Answer every question to see your result.

What does participation involve?

If you join this study, it means that the Coroflex® ISAR NEO stent would be used during your planned heart procedure (stent implantation). Beyond that, the study primarily involves your doctors collecting information about your health and recovery during your regular follow-up appointments. There are no extra medicines to take or special procedures that are not part of your usual care.

The doctors will track your progress over time, checking how well the stent is working and making sure you are recovering as expected. This information is gathered from your existing medical records and routine check-ups. The total duration of your participation would depend on the standard follow-up schedule your doctor recommends after receiving a heart stent, ensuring they can monitor your health and the stent's performance for the necessary period.

Potential risks and benefits

Being part of this study means you would receive a heart stent that is already approved and used by doctors. The main benefit is that your doctors will be very closely monitoring your health and the stent's performance, which can be reassuring. You'll be contributing to important information that helps confirm the stent's safety and effectiveness for future patients. As with any medical procedure, there are always potential risks involved with having a stent implanted, such as bleeding, infection, or issues with the stent itself, but these are risks associated with the procedure itself, not necessarily the study. You always have the right to change your mind and withdraw from the study at any time, without it affecting your medical care.

Locations (23)

Centre Hospitalier du Pays d'Aix
Verified postcode
Aix-en-Provence, France· Recruiting
Centre Hospitalier Ajaccio
Verified postcode
Ajaccio, France· Recruiting
CH Polyclinique Bordeaux Nord Aquitaine
Verified postcode
Bordeaux, France· Recruiting
University Hospital Center of Caen
Verified postcode
Caen, France· Recruiting
Hôpital Albert Schweitzer
Verified postcode
Colmar, France· Recruiting
Hospitalario Universitario (CHU) de Lille
Verified postcode
Lille, France· Recruiting
APHP -Hôpital Lariboisière
Verified postcode
Paris, France· Recruiting
Institut Arnault Tzanck
Verified postcode
Saint-Laurent-du-Var, France· Recruiting
Hospital Universitario A Coruña
Verified postcode
A Coruña, Spain· Recruiting
Hospital Universitario de Badajoz
Verified postcode
Badajoz, Spain· Recruiting
Hospital Universitari Germans Trias I Pujol
Verified postcode
Badalona, Spain· Recruiting
Hospital Universitario de Cruces
Verified postcode
Barakaldo, Spain· Recruiting

Common questions

What kind of heart problem is this study for?

This study is for people who have blocked arteries in their heart, a condition often called Coronary Artery Disease. These blockages can affect how well your heart works.

What is a 'stent'?

A stent is a tiny mesh tube that a doctor places inside a narrowed heart artery to help hold it open, improving blood flow to your heart.

Is this stent new, or is it already used by doctors?

This stent, Coroflex® ISAR NEO, is already in use. This study is an ongoing check to make sure it continues to be safe and works well for patients in everyday practice.

Do I have to do anything extra if I join the study?

No, if you join, you will receive the stent as part of your normal treatment. The study mainly involves your doctors collecting information from your regular check-ups, with no extra tasks for you.

Can I leave the study if I change my mind?

Yes, absolutely. You can decide to leave the study at any point, and it will not affect the medical care you receive from your doctors.

How to find out more

koldobika García San Román, MD, PhD

koldobikags@hotmail.com 0034696704643 Official trial record

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