RecruitingOBSERVATIONAL

Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

This study, called CHANGE, is investigating a new robotic system named R-One, which is used during a common heart procedure called Percutaneous Coronary Intervention (PCI). PCI helps open up blocked or narrowed heart arteries, a condition known as coronary artery disease. The R-One system helps doctors guide wires and stents more precisely during this procedure. This study will involve 500 patients across Europe and South Africa and aims to see how effective and safe this robotic system is in real hospital settings. It's designed to confirm the benefits of using this technology for patients undergoing PCI for their heart condition.

At a glance

Status

Recruiting

Sponsor

Robocath

Enrolment target

500

Start

20 Jun 2023

Estimated completion

01 Jun 2026

Coronary Disease

What is this study about?

Heart disease, specifically coronary artery disease, happens when the blood vessels that supply your heart become narrowed or blocked. This can lead to chest pain or other serious problems. A common and important treatment for this is called Percutaneous Coronary Intervention (PCI), often known as an angioplasty. During a PCI, a doctor inserts a thin tube into a blood vessel, usually in your wrist or groin, and guides it to your heart. They then use small balloons to open up blocked arteries and often place small mesh tubes, called stents, to keep them open.

This study is looking at a new tool called the R-One system. Think of it as a robotic assistant designed to help doctors perform PCI procedures. It allows the doctor to remotely control and move the wires and stents with more precision, while also providing some protection from X-rays. The R-One system isn't meant to replace the doctor; it simply helps them do their job more precisely and safely.

The main goal of the CHANGE study is to see how well this robotic system works and how safe it is when used in everyday hospital practice. Researchers want to make sure it's helpful for patients with coronary artery disease who need a PCI and that it performs as expected over time.

Key takeaways

The study uses a robotic system, R-One, during heart procedures (PCI).
It aims to check the safety and how well the R-One system works.
The robot is controlled by the doctor, not autonomous.
500 patients with coronary artery disease will participate.
Participation involves receiving your standard PCI with robotic assistance.
You can leave the study at any time without affecting your care.

Who may be eligible?

To join this study, you need to be at least 18 years old and have coronary artery disease where your doctor thinks a PCI procedure would be helpful for you. Importantly, your medical team must also believe that using the robotic-assisted PCI system is a suitable approach for your specific heart condition and anatomy.

There are also some reasons why you might not be able to join. For example, if you have certain very severe heart conditions like a STEMI (a serious type of heart attack) or cardiogenic shock (when your heart suddenly can't pump enough blood). Also, if your doctor thinks your heart anatomy isn't suitable for the robotic system, or if you can't or don't want to give your permission to be part of the study, you wouldn't be able to participate.

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 of age or older?
Do you have coronary artery disease?
Has your doctor recommended a PCI procedure for you?
Does your doctor think the robotic-assisted PCI is suitable for your specific condition?
Are you able to give your informed consent to join the study?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll undergo a standard PCI procedure for your coronary artery disease, but it will be performed using the R-One robotic system. You will have regular medical check-ups and assessments as part of your usual care, with the study team collecting information about how you're doing. The specific number of visits and their timing will follow the normal care pathway for someone having a PCI. There won't be any extra medications given as part of this study, as it's observing the robotic system's use during a standard procedure. The researchers will follow up on your health over time to understand the long-term effects. The total duration of your participation will depend on the study's follow-up plan, but it will likely extend beyond your initial procedure to observe the system's performance and your recovery.

Potential risks and benefits

Participating in this study might offer the benefit of receiving your PCI procedure using a cutting-edge robotic system, which aims to enhance precision. However, it's important to remember that, like any medical procedure, there are potential risks associated with PCI itself, which your doctor will discuss with you. The study is particularly looking at the safety of the robotic system, which is already approved for use. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

Het Ziekenhuisnetwerk Antwerpen vzw
Verified postcode
Antwerp, Belgium· Recruiting
Brest university hospital
Verified postcode
Brest, France· Recruiting
Rouen university hospital
Verified postcode
Rouen, France· Recruiting
Centre Cardiologique du Nord
Verified postcode
Saint-Denis, France· Recruiting
Rheinland Klinikum Neuss GmbH
Verified postcode
Neuss, Germany· Recruiting
San Donato Policlinco Kardia
Verified postcode
San Donato Milanese, Italy· Not yet recruiting
Polskie Towarzystwo Kardiologiczne
Verified postcode
Warsaw, Poland· Not yet recruiting
Netcare Christiaan Barnard Memorial Hospital
Verified postcode
Cape Town, South Africa· Not yet recruiting

Common questions

What is PCI?

PCI stands for Percutaneous Coronary Intervention. It's a common procedure used to open blocked heart arteries and improve blood flow to your heart.

What does the R-One robotic system do?

The R-One system is a robotic assistant that helps the doctor precisely guide the tools (like wires and stents) during your PCI procedure.

Is the robot working by itself?

No, the robot is not on its own. It's fully controlled by the doctor, who uses it as a tool to perform the procedure.

Will I have more appointments if I join?

The study aims to observe the robot's use within your standard PCI care, so generally, it shouldn't add many extra appointments beyond what's typical for your condition.

What is coronary artery disease?

This is a condition where the arteries supplying blood to your heart become narrowed or blocked, which can cause chest pain and other problems.

How to find out more

Hamouda Abassi, PhD

hamouda.abassi@robocath.com +33 2 32 10 67 42 Official trial record

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