Active not recruitingNAINTERVENTIONAL

Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)

This study, called FRACTURE, is testing a new treatment for people with coronary artery disease where their heart arteries have become stiff and narrowed due to calcium buildup. The treatment uses a special device called the Bolt Intravascular Lithotripsy System. This system delivers sound waves (like mini shockwaves) inside the artery to gently break up the hard calcium deposits. This makes it easier for doctors to then open the artery fully using standard balloon procedures, which can improve blood flow to the heart. The study is open to patients aged 18 and over in various locations, and it aims to understand how safe and effective this new approach is for improving heart health.

At a glance

Status

Active not recruiting

Phase

Sponsor

Bolt Medical

Enrolment target

426

Start

19 Jan 2024

Estimated completion

20 Mar 2028

Coronary Artery Disease Coronary Artery Calcification

What is this study about?

Heart disease, specifically coronary artery disease, happens when the blood vessels that supply your heart become narrowed and hardened. This often happens because of a buildup of a fatty substance called plaque, and sometimes this plaque can become hardened with calcium, making the arteries stiff and difficult to treat. When this happens, it can make it harder for blood to flow to your heart, leading to problems like chest pain.

This study is looking at a new treatment method called 'intravascular lithotripsy' (IVL). You might have heard of lithotripsy used to break up kidney stones – it uses similar technology. In this case, a tiny device is guided into the affected artery in your heart. It then delivers targeted sound waves to gently crack and loosen the hardened calcium inside the artery wall.

The idea is that by breaking up this tough calcium first, it makes it much easier for doctors to then use a small balloon to fully open the artery. This can restore better blood flow to your heart. The FRACTURE study wants to see how well this new treatment works and if it's a safe and effective option for patients with calcium-hardened heart arteries.

Key takeaways

This study explores a new way to treat calcium-hardened heart arteries.
It uses sound waves to break up calcium before opening the artery.
The treatment is called Intravascular Lithotripsy (IVL).
It's for people aged 18+ with specific types of heart artery disease.
There are strict health checks to make sure you're suitable.
Participation involves the procedure and follow-up monitoring.

Who may be eligible?

To join this study, you need to be at least 18 years old and have heart artery disease that your doctor thinks can be helped by a procedure to open the artery. You might have chest pain or other symptoms related to this.

Your doctor will check if you have significant calcium buildup in the affected artery. This might be seen on X-rays of your heart or with special cameras that look inside the artery. You can't have had a recent heart attack (within the last 30 days) or severe heart failure. Conditions like serious kidney problems or needing certain heart support devices would also prevent you from joining.

Quick self-check

Are you 18 years old or older?
Do you have heart artery disease that needs a procedure to open it?
Has your doctor seen significant calcium in your heart artery?
Have you had a heart attack in the last 30 days? (If yes, you likely can't join)
Do you have severe heart failure or serious kidney problems? (If yes, you likely can't join)

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 undergo the intravascular lithotripsy procedure as part of your treatment. This is similar to a standard heart artery procedure. Before the procedure, doctors will perform some checks, like blood tests and possibly a stress test, to confirm you meet the study requirements. During the procedure, the special device will be used to treat the calcium in your heart artery, followed by standard balloon treatment. Researchers will then monitor your progress and recovery, likely involving follow-up visits or calls to check on your heart health, and to understand how well the treatment worked for you. The total duration of your participation will include the procedure itself and a period of follow-up after that.

Potential risks and benefits

Taking part in this study might offer a potential benefit if this new treatment helps to better open your hardened heart artery, potentially improving blood flow and reducing symptoms. However, as with any medical procedure, there are potential risks, including those associated with heart artery procedures like bleeding, infection, or issues related to the devices used. You will be closely monitored, and your doctor will discuss all potential risks with you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (46)

Scripps Health
La Jolla, United States
Cedars-Sinai Heart Institute
Los Angeles, United States
Riverside Community Hospital
Riverside, United States
Southern California Permanente Medical Gp. / Kaiser Permanente
San Diego, United States
Los Robles Hospital & Medical Center
Thousand Oaks, United States
Medical Center of the Rockies
Loveland, United States
Nova Clinical Research Centers/Manatee Memorial Hospital
Bradenton, United States
The Cardiac & Vascular Institute
Gainesville, United States
HCA FL Memorial Hospital
Jacksonville, United States
HCA Florida Largo Hospital
Largo, United States
Northeast Georgia Medical Center
Gainesville, United States
Wellstar Research Institute
Hiram, United States

+34 more sites — see the official record for the full list.

Common questions

What is coronary artery disease?

It's a common heart condition where the arteries supplying blood to your heart become narrowed and hardened, often due to plaque and calcium buildup.

What is calcium buildup in heart arteries?

It's when hard, stony deposits of calcium form in the walls of your heart arteries, making them stiff and difficult to open.

How does 'intravascular lithotripsy' work?

It uses special sound waves delivered inside the artery to gently break up the hardened calcium, making it easier to treat.

Is this a new treatment?

Yes, this study is testing this specific device and method to understand how well it works for treating calcium in heart arteries.

Will I get 'better' if I join?

This study aims to find out if this treatment is effective. We cannot guarantee personal benefit, but your participation helps doctors learn more.