RecruitingNAINTERVENTIONAL

Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

This study, called OSCAR, is exploring better ways to treat arteries in your heart that have become narrowed again after having a stent fitted, especially when the stent isn't fully expanded. This problem, known as in-stent restenosis, affects a significant number of people after heart procedures. Current treatments often don't fully solve the issue, leading to further problems. The study compares a new technique called intravascular lithotripsy (IVL), which uses sound waves to break up blockages, with traditional balloon treatments. Doctors want to find out if IVL is a safer and more effective way to ensure stents are fully open, helping to prevent future heart issues and improve patient well-being.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Clermont-Ferrand

Enrolment target

Start

22 Oct 2025

Estimated completion

01 Sep 2031

Coronary Angioplasty Restenosis Lithotripsy Restenosis of Coronary Artery Stent Angioplasty, Transluminal, Percutaneous Coronary Percutaneous Coronary Intervention (PCI)OCT Angiography Optical Coherence Tomography (OCT)Intravascular Lithotripsy; Rotational Atherectomy; OFDI Intravascular Lithotripsy Coronary Artery Disease Coronary Artery Disease (CAD)Coronary Stent Restenosis

What is this study about?

When you have a procedure to open up a blocked artery in your heart (like an angioplasty with a stent), sometimes the artery can narrow again. This is called 'in-stent restenosis'. It can happen for different reasons, but often it's because the stent wasn't fully opened, or 'under-expanded', in the first place, especially if the artery walls are hard and calcified.

Doctors currently use special balloons to try and widen these stents, but these aren't always completely successful. This can lead to ongoing symptoms like chest pain (angina) or even more serious heart problems. There's a growing interest in a new technique called intravascular lithotripsy, or IVL. This method uses tiny sound waves to gently break up hard calcium deposits in the artery walls, which could help the stent expand more fully.

The OSCAR study aims to compare IVL with the standard balloon treatments. By doing this, doctors hope to understand if IVL is a more effective and safer way to treat these stubborn blockages, ensuring that stents are properly opened. This could lead to better long-term results for patients and reduce the chances of needing further procedures. It's about finding the best way to help your heart arteries stay open.

Key takeaways

The study compares a new technique (IVL) with standard balloon treatments.
It focuses on heart arteries that have narrowed again after a stent.
The goal is to find safer and more effective ways to open up these arteries.
Participation involves a procedure and regular check-ups.
It could lead to better future treatments for heart conditions.

Who may be eligible?

This study is looking for people who have had a heart stent put in previously, and now that stent is narrowed again by at least 50%. Doctors need to suspect that the stent isn't fully expanded, possibly because of hardened calcium in the artery wall. The artery that needs treating should be a certain size, not too small or too large, and your blood flow through it needs to be good.

Alongside this, you'll need to be well enough to take part. This means your heart should be reasonably strong, and you shouldn't have severe kidney problems. You also can't be pregnant or breastfeeding. You must be able to take two specific anti-clotting medications for at least six months after the procedure.

There are also some reasons you wouldn't be able to join. For example, if you have very severe heart failure, a very weak heart (LVEF less than 20%), or existing blood clots in the artery being treated. You also can't be part of another trial for a new drug or device, unless the rules of that trial allow it.

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.

Have you had a heart stent that is now narrowed again by at least 50%?
Do doctors suspect your stent isn't fully expanded?
Are you able to take two specific anti-clotting medications for at least 6 months?
Are you generally in good health without severe heart or kidney problems?
Are you over 18 and not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll undergo the standard procedure to treat your narrowed artery, but doctors will use either the IVL device or a special balloon, chosen randomly. They will then follow your health closely over time to see how well the treatment worked.

This involves regular check-ups and possibly some imaging tests, like OCT Angiography, to look at your artery from the inside. The study aims to follow participants for a period, with visits to check on your recovery and any symptoms you might have. You'll need to take specific medications for a certain time after your procedure. The total duration of your participation will depend on the study's follow-up schedule.

Potential risks and benefits

Taking part in this study could offer you access to a new treatment (IVL) that might be more effective for your specific condition than standard methods, potentially leading to a better outcome for your heart health. However, like all medical procedures, both the new and standard treatments carry potential risks such as bleeding, infection, or complications related to the heart procedure itself. You will be closely monitored, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (2)

Clermont Ferrand Hospital
Verified postcode
Clermont-Ferrand, France· Recruiting
CHU de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Not yet recruiting

Common questions

What is 'in-stent restenosis'?

It's when an artery in your heart narrows again after a stent has been put in to keep it open.

What is IVL?

IVL, or intravascular lithotripsy, uses sound waves to break up hard deposits inside your arteries, helping them to open better.

Why is this study important?

It's trying to find a better and safer way to treat these narrowed arteries, especially when previous treatments haven't worked well.

Will I know which treatment I get?

The treatment you receive will be chosen randomly, so neither you nor your doctor can decide. This helps ensure the study results are fair.

How long will I be followed up?

The study involves regular check-ups and monitoring after your procedure, with the exact duration depending on the study's plan.

How to find out more

Lise Laclautre, Pharm.D

promo_interne_drci@chu-clermontferrand.fr +33473754963 Official trial record

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