RecruitingNAINTERVENTIONAL

FORWARD CAD IDE Study

This research trial, called FORWARD CAD IDE, is investigating a new tool for people who have coronary artery disease (CAD), where the arteries supplying the heart become hardened. The study focuses on a device called the Shockwave Javelin Coronary IVL System, which uses special sound waves (intravascular lithotripsy) to treat tough, calcified blockages in heart arteries. The main goal is to see if this device can safely and effectively prepare these hardened arteries for a stent, making it simpler for doctors to treat the blockage. This approach aims to soften up the calcium in the arteries, making them more flexible for further treatment. The trial will involve many patients across different hospitals.

At a glance

Status

Recruiting

Phase

Sponsor

Shockwave Medical, Inc.

Enrolment target

408

Start

04 Apr 2025

Estimated completion

01 Dec 2027

Coronary Arterial Disease (CAD)

What is this study about?

This study is called the FORWARD CAD IDE Study, and it's looking into a new way to help people with a common heart condition called coronary artery disease. This is where the blood vessels that supply your heart become narrowed and hardened, often due to a build-up of calcium, which can make it difficult for blood to flow properly.

The trial is testing a new device called the Shockwave Javelin Coronary IVL System. Think of it like this: if your artery is like a stiff, calcified pipe, this device uses special sound waves (similar to how kidney stones are broken up) to gently crack and soften the calcium within the artery. The idea is to make the artery walls more flexible, so that when doctors later insert a small mesh tube called a stent to keep the artery open, it's a much easier and safer process. This device is designed to be very precise and help doctors treat blockages that are usually very tough to get through.

In simple terms, this study wants to find out if using these sound waves to prepare a hardened artery before putting in a stent is a safe and effective way to help people with heart disease. Doctors hope it will make the procedure smoother and lead to better results for patients who have these challenging calcified blockages. The study will involve a number of patients to gather enough information about how well the device works and if it's safe.

Key takeaways

This study tests a new device that uses sound waves to treat hardened heart arteries.
It aims to make placing a stent easier in tough, calcified arteries.
It's for people with coronary artery disease who need a planned procedure, not an emergency.
The device is called the Shockwave Javelin Coronary IVL System.
Participation involves receiving the treatment and follow-up checks.
You can stop taking part at any time without affecting your normal care.

Who may be eligible?

To join this study, you need to be at least 18 years old and willing to follow all the study instructions. You should have coronary artery disease, which means you have narrowed heart arteries, and your doctor thinks a procedure to open them (called PCI or angioplasty) is right for you. This procedure shouldn't be an emergency.

Your heart's pumping ability also needs to be reasonably strong, generally above 30%. Also, you should have a good chance of living for at least another year. There are also specific medical checks, like certain blood test results (for a chemical called troponin), that need to be within certain levels. These help ensure you're stable enough to take part.

If you have other blockages in different heart vessels that need treatment, there are also rules about when and how those can be treated in relation to this study. The main goal is to ensure that patients joining the study are suitable for the specific treatment being tested.

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 old or older?
Do you have coronary artery disease that needs a non-emergency procedure?
Is your heart's pumping ability (LVEF) fairly good (over 30%)?
Are you able to attend all study appointments and follow instructions?
Have you been told you have a reasonable life expectancy (more than 1 year)?
Have your doctors indicated your recent blood tests (troponin) are within acceptable limits for a non-emergency procedure?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors and nurses will first make sure you meet all the necessary health requirements. If you do, you'll be one of around 158 people initially included in the main part of the study, and possibly an additional 250 people in a later stage. The main treatment involves using the Shockwave Javelin Coronary IVL System during your procedure to open your blocked heart artery (angioplasty and stenting).

During and after this procedure, doctors will carefully check how well the device works and if there are any side effects. You will have several follow-up appointments and assessments after your procedure to monitor your health and the condition of your heart artery. The exact number of visits, tests, and how long you'll be followed up will be explained in full by the study team, but it will involve a period of monitoring your progress.

Potential risks and benefits

Taking part in this study might offer you the potential benefit of being among the first to receive this new treatment for hardened heart arteries, which could lead to a smoother and more effective procedure for your blockage. However, as with any medical procedure, there are potential risks, such as bleeding, infection, or other complications related to the heart procedure itself. The study doctors will carefully explain all known and potential risks to you. Remember, joining is completely voluntary, and you are free to withdraw from the study at any time without it affecting your usual medical care.

Locations (34)

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

Scripps Health
Verified postcode
La Jolla, United States· Recruiting
University of California, San Francisco
Verified postcode
San Francisco, United States· Recruiting
South Denver Cardiology Associates, P.C
Verified postcode
Littleton, United States· Recruiting
Hartford Hospital
Verified postcode
Hartford, United States· Recruiting
Medstar Washington Hospital Center
Verified postcode
Washington D.C., United States· Recruiting
The Cardiac and Vascular Institute
Verified postcode
Gainesville, United States· Recruiting
Piedmont Heart Institute
Verified postcode
Atlanta, United States· Recruiting
Emory University Hospital
Verified postcode
Atlanta, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
Brigham and Women's Hospital
Verified postcode
Boston, United States· Recruiting
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States· Recruiting
Minneapolis Heart Institute
Verified postcode
Minneapolis, United States· Recruiting

Common questions

What is Coronary Artery Disease (CAD)?

CAD is when the blood vessels that supply your heart become narrowed and hardened, often due to a build-up of fatty deposits and calcium, making it harder for blood to flow.

What does 'Intravascular Lithotripsy' mean?

It's a medical technique that uses special sound waves (like mini-shockwaves) inside your blood vessels to break up or soften hard calcium deposits in your arteries.

What is the Shockwave Javelin Coronary IVL System?

It's a new device being tested that uses those sound waves to make stiff, calcified heart arteries more flexible before a stent is put in, hoping to make the procedure easier.

Will I get an actual stent as part of this study?

Yes, the goal of using this device is to prepare your calcified artery so that a stent can be more easily placed afterwards to keep the artery open.

Is this an emergency treatment?

No, this study is for planned, non-emergency procedures. You should be in a stable condition if you're considered for this trial.

How to find out more

Randee Randoll

rrandoll@its.jnj.com 408-577-7856 Official trial record

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