Active not recruitingOBSERVATIONAL

Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience From 2009 to 2015

This study, conducted at a single hospital in the UK, examines the long-term results of a heart treatment called drug-coated balloon angioplasty. For people with blocked heart arteries, this procedure uses a special balloon to open the artery and deliver medicine, without leaving a permanent stent. Researchers are looking back at the records of over 1,000 patients who received this treatment between 2009 and 2015. They want to see how effective and safe this treatment was by checking on patients' health, including any major heart issues, for up to 10 years after their procedure. The goal is to better understand how this treatment helps people with heart problems.

At a glance

Status

Active not recruiting

Sponsor

Julie Dawson

Enrolment target

1,000

Start

11 Sep 2017

Estimated completion

31 Jan 2027

Ischaemic Heart Disease

What is this study about?

This study is like looking back through old records to learn about a specific heart treatment called drug-coated balloon angioplasty. Imagine you have tubes (arteries) that carry blood to your heart, and sometimes these tubes can get narrowed or blocked. This is called ischaemic heart disease.

Traditionally, doctors might use a small metal mesh tube called a stent to keep the artery open. But with a drug-coated balloon, doctors use a special balloon that opens the artery and also delivers medicine to help prevent it from narrowing again. Once the medicine is delivered, the balloon is removed, and no permanent stent is left behind. This particular study is looking at patients who received this treatment at one hospital in the UK between 2009 and 2015.

The researchers are checking how these patients fared over many years, some for up to a decade, to see how well the treatment worked for them in real-world situations. They are trying to understand things like how often patients had further heart problems or needed more treatments. By gathering this information, doctors can get a clearer picture of how beneficial this drug-coated balloon treatment is for people with different types of heart artery problems.

Key takeaways

This study is reviewing old patient records from a UK hospital.
It focuses on a heart treatment called drug-coated balloon angioplasty.
Researchers are tracking how patients did over 10 years after their treatment.
The aim is to understand the long-term safety and effectiveness of this treatment.
This information helps doctors make better choices for future heart patients.

Who may be eligible?

This study is looking back at information from patients who have already had a specific heart treatment. Therefore, you wouldn't be 'joining' this study in the traditional sense, as the treatment has already taken place.

The researchers are focusing on people who received a drug-coated balloon angioplasty for heart artery disease at the Norfolk and Norwich University Hospital between January 1, 2009, and December 31, 2015.

Anyone who had this procedure at that hospital during that time, regardless of their age (between 18 and 100 years old) or gender, would have their anonymous information included in this review.

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.

Did you have a heart procedure?
Was it a drug-coated balloon angioplasty?
Did you have it at Norfolk and Norwich University Hospital?
Was it between January 1, 2009, and December 31, 2015?
Were you between 18 and 100 years old at the time?

Answer every question to see your result.

What does participation involve?

This study is reviewing existing patient records from a hospital. This means you wouldn't need to take any medicine, attend extra appointments, or have any special checks beyond your usual medical care. The researchers are simply looking at information that's already been collected about patients who had a specific heart treatment between 2009 and 2015. They will track outcomes for up to 10 years by accessing health records.

Potential risks and benefits

Since this study is only looking at existing, anonymous patient records, there are no direct risks to individuals who had the treatment. Similarly, there are no direct benefits to individuals, as the treatment has already occurred. However, the study's findings will help healthcare professionals better understand the long-term effectiveness of drug-coated balloon angioplasty, which could benefit future patients with similar heart conditions by improving treatment decisions. Because it's a review of past data, patients are not actively participating and thus don't need to withdraw.

Locations (1)

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

Norfolk and Norwich University Hospital
Verified postcode
Norwich, United Kingdom

Common questions

What is ischaemic heart disease?

It's when the blood flow to your heart is reduced, often because of narrowed or blocked arteries, which can lead to chest pain or a heart attack.

What is a drug-coated balloon angioplasty?

It's a heart procedure where a special balloon opens a blocked heart artery and delivers medicine to stop it from narrowing again. Unlike a stent, no permanent device is left inside.

Why is this study important?

It helps doctors understand how well this drug-coated balloon treatment works over many years for people with heart problems, which can help improve future patient care.

Will I need to do anything if my data is included?

No, this study uses existing, anonymous information from past treatments. You won't need to do anything at all.

Is this a new treatment?

The study looks at results from 2009-2015, and while it was considered a 'novel therapy' then, it is now a more established option for certain heart conditions.