RecruitingOBSERVATIONAL

Coronary Bifurcations With Ischaemia and Flow Assessment

The "Coronary Bifurcations With Ischaemia and Flow Assessment" study looks at how we treat blockages in the heart's arteries, specifically when these blockages happen at a branching point. Often, doctors use small metal tubes called stents to open up these narrowings. However, treating blockages at a branch can be tricky. A newer option is a drug-coated balloon, which opens the artery and releases medicine without leaving a metal stent behind. This study compares these two methods to see which is more effective. We'll use special imaging to understand blood flow and check on patients over time to see how well they're doing.

At a glance

Status

Recruiting

Sponsor

University of East Anglia

Enrolment target

Start

10 Oct 2023

Estimated completion

01 Jun 2026

Coronary Bifurcation Lesions

What is this study about?

Your heart needs a constant supply of oxygen-rich blood, delivered by special blood vessels called coronary arteries. Sometimes, these arteries can become narrowed or blocked, which can lead to chest pain (angina) or even a heart attack. When a narrowing happens at a point where an artery splits into two smaller branches, it's called a 'bifurcation lesion'. These types of blockages can be more challenging to treat than others.

Currently, many doctors use tiny mesh tubes called 'stents' to hold open narrowed arteries. However, for blockages at branching points, using stents can sometimes be more complicated. This study is exploring a different approach: using a 'drug-coated balloon'. This special balloon is inflated inside the narrowed artery, releasing medicine that helps keep the artery open. A key difference with this method is that it doesn't leave a permanent metal scaffold inside your body, unlike a stent.

Our research aims to carefully compare these two treatments – drug-coated balloons versus stents – for blockages at branching points. We want to understand which method results in better blood flow and long-term heart health. We will use advanced scanning techniques to create detailed computer models of blood flow before and after treatment. We will also keep in touch with participants over time to monitor their recovery and overall well-being, gathering important information to help improve future care for patients like you.

Key takeaways

Compares two treatments for blocked heart arteries at branching points.
Investigates drug-coated balloons versus traditional stents.
Uses advanced imaging to assess blood flow before and after treatment.
Follows patients over time to track long-term success.
Aims to improve future treatment for specific heart conditions.

Who may be eligible?

To join this study, you must be 18 years or older and have a narrowing in one of your heart arteries where it splits into two smaller branches. This narrowing should be suitable for a standard treatment approach. Your main artery at the site of the narrowing should be at least 2.5mm wide, and the side branch at least 2mm wide. You might be eligible if you experience stable chest pain, 'silent' lack of oxygen to the heart, unstable chest pain, or have had a certain type of heart attack (NSTEMI). It's also essential that you are able to understand the study and willingly agree to take part.

There are some reasons why you might not be able to join. These include if you are in a state of severe heart failure (cardiogenic shock), have very poor heart pumping ability (LVEF less than 30%), or have had a different severe type of heart attack (STEMI) where you wouldn't be able to give your consent. Other reasons include very poor kidney function, severe asthma that prevents the use of certain medications, or some heart rhythm problems. Also, you cannot be pregnant, unable to provide consent, or have a specific type of blockage in the main artery leaving your heart.

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 or older?
Do you have a heart artery blockage at a branching point that doctors can treat?
Do you have stable chest pain, 'silent' reduced blood flow to the heart, or certain types of heart attacks?
Are you able to understand the study and agree to take part?
Are you NOT pregnant and do not have severe heart failure or very poor kidney function?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the doctors will use special imaging tools called optical coherence tomography (OCT) and pressure wires during your procedure. These tools help them get a very detailed look at your artery and measure blood flow before and after your treatment. You will receive either a drug-coated balloon or a standard drug-eluting stent. After your procedure, we will follow up with you over an extended period. This will involve regular check-ups, which may include further imaging or tests, to see how well the treatment is working and how you are feeling. The exact number and timing of visits will be explained in detail by the study team, but the overall duration of your involvement will allow us to track your progress long-term.

Potential risks and benefits

Taking part in this study may offer the benefit of receiving a highly monitored and potentially effective treatment for your heart condition, contributing to medical knowledge that could help future patients. There are always some risks with any medical procedure, and these will be fully explained to you by the medical team. These might include risks associated with the procedure itself or the imaging techniques used. It's very important to remember that participating is completely your choice, and you are free to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Norwich Medical School, University of East Anglia
Verified postcode
Norwich, United Kingdom· Recruiting

Common questions

What is a 'bifurcation lesion'?

It's when a blockage in a heart artery happens right where it splits into two smaller branches.

What's the difference between a stent and a drug-coated balloon?

A stent is a tiny metal mesh tube that stays in your artery, while a drug-coated balloon opens the artery and leaves medicine behind but no metal.

Why is this study important?

It helps us learn which treatment works best for specific types of heart artery blockages, potentially improving future care for patients.

Will I know which treatment I receive?

The study design will be fully explained, and generally in studies like this, patients will know which treatment they are getting, but details differ by study.

What imaging will be used?

Special imaging like Optical Coherence Tomography (OCT) and pressure wires will be used during your procedure to get a detailed view of your artery and blood flow.

How to find out more

Natasha Corballis, MBBS, MRCP (UK), MSc

natasha.corballis@nnuh.nhs.uk 01603286286 Official trial record

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