Observatory on the Use of the Shockwave Medical C2 Coronary Lithotripsy System in the General Population in France.
This study is gathering information about a new tool called the Shockwave C2. This device helps treat hardened (calcified) arteries during a common heart procedure called an angioplasty. As more people are developing hardened arteries, often due to conditions like diabetes, it's becoming more important to find effective ways to treat them. Traditional methods for dealing with very hard arteries aren't always used widely and can have some risks. The Shockwave C2 uses pulses, similar to sound waves, to gently break up the hardened areas in the artery before a tiny balloon is used to open it further. Researchers in France are observing how this new device performs and how safe it is for people undergoing these procedures.
At a glance
What is this study about?
Heart disease is a major concern, and sometimes the arteries that supply blood to your heart can become hardened and stiff, a process called calcification. This is becoming more common, partly because of conditions like diabetes, and it can make treatments more difficult. When these arteries get too stiff, it can be tricky to open them up properly during a procedure called an angioplasty, where doctors widen narrowed arteries, often by inserting a small tube called a stent.
Traditional methods for treating these very hard arteries haven't always been widely used, and sometimes they come with their own set of challenges. This study is looking at a new device called the Shockwave C2 Coronary Lithotripsy System. Think of it like using very gentle, precise sound waves to create tiny cracks in the hardened artery wall. This makes the artery more flexible, so it's easier and safer for doctors to then use a small balloon to open it up and potentially place a stent.
The main goal of this particular study is to watch how well the Shockwave C2 device works and how safe it is for patients in France who are having an angioplasty. It's an important step in understanding if this new technology can offer a better way to treat people with calcified arteries, making their heart procedures more successful and potentially reducing complications.
Key takeaways
- The study looks at a new device for hardened heart arteries.
- It aims to improve standard heart procedures (angioplasty).
- The Shockwave C2 uses gentle pulses to prepare arteries.
- It's being observed in patients in France.
- The goal is to understand how safe and effective it is.
Who may be eligible?
To be considered for this study, you must be at least 18 years old and be covered by the French National Health Insurance System. You would be included if your doctor decides that the Shockwave Medical C2 Coronary Lithotripsy System is the right treatment for you during your heart angioplasty procedure.
In some specific cases, you might be included if a previously placed heart stent isn't opening up as it should (this is called stent underexpansion), and it meets certain measurements seen on special heart scans. Finally, you must be willing to take part in the study.
You would not be able to join if you are under 18 years old, or if you are pregnant or breastfeeding. Also, if you do not wish to participate, or if you are unable to give your informed consent due to legal reasons (for example, if you have a guardian), then you would not be eligible.
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 a heart condition needing an angioplasty where the Shockwave C2 device might be used?
- Are you willing to have your medical information used for this study?
- Are you NOT pregnant or breastfeeding?
What does participation involve?
This study is an 'observatory' study, which means doctors will be watching how well the Shockwave C2 device works and how safe it is during a standard heart angioplasty procedure. You won't be asked to take any new medications just for the study. The doctors will follow their usual procedures for your angioplasty. Afterwards, they will collect information from your medical records about how the procedure went and your recovery. This typically involves using information that would already be gathered as part of your normal medical care. The total duration of your participation would depend on the follow-up schedule typically used for patients undergoing angioplasty for calcified lesions, to see how you are doing over time.
Potential risks and benefits
Locations (1)
- Clinique PasteurVerified postcodeToulouse, France· Recruiting
Common questions
What is an angioplasty?
An angioplasty is a common procedure where doctors widen narrowed or blocked blood vessels, often in the heart, usually using a small balloon.
What does 'calcified arteries' mean?
It means your arteries have become hardened and stiff due to a build-up of calcium, making them less flexible.
What is the Shockwave C2 device?
It's a new tool that uses gentle pulses, like sound waves, to break up hardened areas inside your arteries, making them easier to treat.
Is this device new to medicine?
The principle of lithotripsy (using waves to break things) has been around, but this specific device is a newer technology for treating hardened heart arteries.
Will I have extra appointments if I join?
This study aims to collect information from your standard care, so it's unlikely you'll have extra appointments solely for the study. Your doctor will confirm this.
How to find out more
Benjamin HONTON
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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