Active not recruitingOBSERVATIONAL

Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease

This study is for women who have hardened arteries in their heart. We want to see how a new treatment, called coronary IVL, works for them. When arteries become hard, it can make them narrow, which is called coronary artery disease. This treatment uses gentle sound waves to help unblock these arteries. The study will follow women after they have this treatment along with a stent. We want to understand if this treatment is effective and if it helps women feel better and stay healthy over several years. It's a real-world study, meaning we're observing how the treatment works in everyday medical care across different hospitals in the UK, Europe, and the US.

At a glance

Status

Active not recruiting

Sponsor

Shockwave Medical, Inc.

Enrolment target

399

Start

03 May 2023

Estimated completion

01 Apr 2028

Coronary Artery Disease

What is this study about?

This study is called "Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease." That's a very long name, so let's break it down into simpler terms. Essentially, it's looking at a new way to treat a common heart condition called coronary artery disease.

Coronary artery disease happens when the blood vessels that supply your heart become narrowed or blocked, often due to a build-up of fatty deposits and hardening, called calcification. This can lead to chest pain, breathlessness, and even heart attacks. A common treatment is called a PCI (percutaneous coronary intervention), which involves using a small balloon and a stent (a tiny mesh tube) to open up the artery and keep it open. However, when the artery is very hard and calcified, it can be tricky to treat.

This study is focusing on a new technique called coronary IVL (intravascular lithotripsy). This uses gentle sound waves, similar to those used to break up kidney stones, to soften the hardened calcium in the arteries. This can make it easier to open them up and place a stent effectively. The main aim of this study is to see how well this new IVL treatment works specifically for women who have these calcified arteries and to gather information over several years about their health and how they are doing.

Key takeaways

This study is for women with hardened heart arteries.
It's looking at a new treatment called coronary IVL to help unblock arteries.
You'll receive the IVL treatment and a stent as part of your care.
The study involves follow-up appointments over three years.
It aims to understand how this treatment works in real-world settings.

Who may be eligible?

This study is specifically looking for women aged 18 or over. You might be suitable if you have coronary artery disease where your heart arteries have become hard and narrowed, and your doctor thinks you need a procedure to unblock them using both the new coronary IVL treatment and a stent.

It's important that you are willing and able to come to follow-up appointments after your procedure. You also need to agree to take part in the study and sign a form that says you understand what the study involves.

There are also some reasons why you might not be able to join. For example, if you have another serious illness that might affect your ability to take part or could shorten your life expectancy to less than a year. If you have very severe heart problems during the procedure, or if you can't take the usual blood-thinning medicines, you wouldn't be able to join. Also, if you're already in another study for a new medicine or device, you probably wouldn't be eligible for this one.

Quick self-check

Are you a woman aged 18 or older?
Do you have hardened arteries in your heart that need a procedure?
Has your doctor recommended PCI with coronary IVL and a stent?
Are you able and willing to attend follow-up appointments for approximately three years?
Are you not currently pregnant?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will have your usual procedure to open up your heart arteries, which will include the coronary IVL treatment and a stent. This is standard care, but in this study, your recovery will be carefully monitored.

Before you leave the hospital after your procedure, you'll have a check-up. Then, you'll have follow-up appointments at roughly 30 days, one year, two years, and three years after your procedure. These appointments will help the doctors understand how you are getting on and how well the treatment has worked over time. They will likely involve questions about your health and some routine medical checks. The full duration of your participation, including all follow-up appointments, will be about three years.

Potential risks and benefits

Participating in this study means you will receive a treatment (coronary IVL and a stent) that your doctor believes is best for your heart condition. The potential benefit is that the coronary IVL technique may help to effectively open up your arteries, especially if they are very hardened, and improve your heart health. As with any medical procedure, there are potential risks, such as bleeding, infection, or other complications associated with heart procedures or the devices used. These will be discussed fully with you by your medical team. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (49)

Loma Linda University Health
Loma Linda, United States
Good Samaritan Hospital
Los Angeles, United States
Kaiser Permanente - San Francisco Medical Center
San Francisco, United States
Stanford University
Stanford, United States
South Denver Cardiology Associates, P.C
Littleton, United States
Yale New Haven Hospital
New Haven, United States
Morton Plant Hospital
Clearwater, United States
Tallahassee Research Institute
Tallahassee, United States
Emory Hospital
Atlanta, United States
Piedmont Heart Institute
Atlanta, United States
Northside Hospital
Atlanta, United States
Northwestern University
Evanston, United States

+37 more sites — see the official record for the full list.

Common questions

What is coronary artery disease?

It's a condition where the blood vessels supplying your heart become narrowed or blocked, often due to hardening and build-up inside the arteries.

What is coronary IVL?

It's a treatment that uses gentle sound waves to soften hardened parts within your heart arteries, making it easier to open them up.

Why is this study focused on women?

The study aims to gather specific information on how well this treatment works for women, as there can be differences in how conditions and treatments affect men and women.

Will I get a new medicine in this study?

No, this study is looking at a medical device (the coronary IVL system) and how it's used in conjunction with a stent, not an experimental drug.

How long will I be involved in the study?

You'll be involved for about three years, including your initial procedure and several follow-up appointments.