Active not recruitingNAINTERVENTIONAL

Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

This research study, called ALL-RISE, is looking at how doctors decide the best treatment for blocked heart arteries. Specifically, it's comparing two methods: FFRangio and the standard pressure wire technique. Both help doctors understand how much a blockage is affecting blood flow. The main goal is to see if FFRangio-guided treatment is as effective as the traditional pressure wire method in preventing serious heart problems for patients undergoing a procedure called Percutaneous Coronary Intervention (PCI). PCI is a common treatment to open up narrowed or blocked arteries in the heart. The study will follow patients for one year to track their progress.

At a glance

Status

Active not recruiting

Phase

Sponsor

CathWorks Ltd.

Enrolment target

1,924

Start

21 Jun 2023

Estimated completion

01 May 2026

Percutaneous Coronary Intervention

What is this study about?

Imagine your heart arteries are like pipes carrying blood to your heart. Sometimes, these pipes can get narrowed or blocked, which doctors call coronary artery disease. When this happens, your heart might not get enough blood, and you might experience chest pain or other symptoms. Doctors sometimes recommend a procedure called Percutaneous Coronary Intervention (PCI), also known as an angioplasty and stenting, to open up these blocked arteries and improve blood flow.

Before doing a PCI, doctors need to figure out exactly which blockages are causing problems and how severe they are. This study is comparing two different ways doctors can gather this important information. One way uses a very thin wire (a 'pressure wire') that's guided into your artery to measure blood pressure and flow directly. The other way, called FFRangio, uses special X-ray images (angiograms) to estimate the blood flow information without needing a physical wire in the same way. Both methods help doctors decide if a blockage needs treating and how best to do it.

The ALL-RISE study wants to see if using FFRangio to guide treatment decisions is just as good, or 'non-inferior,' to the traditional pressure wire method. This means they are checking if patients who have their treatment planned with FFRangio have similar good results and avoid serious heart problems over one year, compared to those whose treatment is planned with the pressure wire. It's important to find the best and safest ways to treat heart conditions.

Key takeaways

Compares two ways to plan heart artery treatment: FFRangio vs. traditional pressure wire.
Aims to see if FFRangio is as effective in preventing serious heart problems.
Involves adults (18+) with narrowed heart arteries needing PCI.
Patients will be followed for one year after their procedure.
Your participation helps improve heart care for future patients.

Who may be eligible?

This study is looking for adults aged 18 or older who have heart artery disease where one or more arteries are narrowed by 50% to 90%. Your doctor must think that both the pressure wire and FFRangio methods could be used to check your heart. You wouldn't be able to join if you've had a very recent heart attack (within 3 days), or if you've had certain types of heart bypass surgery where the repaired vessels are still working, or if your heart muscle is very weak (LVEF 30% or less).

You also can't take part if you are pregnant or breastfeeding, or if your doctor believes you have less than a year to live. If you're already in another research study that might affect the results of this one, you also wouldn't be eligible. There are also specific reasons related to the details of your heart scan (angiogram) that might mean you can't join, such as very poor blood flow in your heart vessels or if the main heart artery (left main) is severely narrowed.

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 narrowed heart arteries (50-90% blockage) that your doctor thinks need assessment?
Have you had a recent heart attack (within 3 days)? (If yes, you may not be able to join)
Are you pregnant or breastfeeding? (If yes, you may not be able to join)
Does your doctor think you might have less than a year to live? (If yes, you may not be able to join)

Answer every question to see your result.

What does participation involve?

If you join this study, you might have some extra tests or procedures related to deciding your heart treatment. Your doctors will use either the FFRangio method or the traditional pressure wire method to guide decisions about your Percutaneous Coronary Intervention (PCI) — a procedure to open blocked arteries. After your PCI, the study team will follow your health for one year. This will involve regular check-ups, which might be in person or by phone, to see how you are doing and to track any major heart events. The total duration of your active participation will be about one year.

Potential risks and benefits

Like any medical procedure, there are potential risks with procedures to assess and treat heart arteries, including bleeding, infection, or very rarely, more serious heart problems. The study aims to determine if FFRangio guidance is as safe and effective as standard care, so you would receive one of two established methods for guiding your treatment. There are no direct benefits to you from participating in the study itself beyond the treatment you would receive as standard care, but your participation can help improve future care for others with similar heart conditions. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (59)

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

University of California San Diego Health
Verified postcode
La Jolla, United States
VA- Long Beach Healthcare
Verified postcode
Long Beach, United States
Keck Medicine of USC
Verified postcode
Los Angeles, United States
UCLA Medical Center
Verified postcode
Los Angeles, United States
Stanford University
Verified postcode
Palo Alto, United States
VA - Palo Alto Healthcare
Verified postcode
Palo Alto, United States
Kaiser Permanente San Francisco
Verified postcode
San Francisco, United States
St. Joesph's Medical Center
Verified postcode
Stockton, United States
HCA Florida JFK Hospital
Verified postcode
Atlantis, United States
Cardiac & Vascular Institute
Verified postcode
Gainesville, United States
University of Miami
Verified postcode
Miami, United States
HCA Florida Northside Hospital
Verified postcode
St. Petersburg, United States

Common questions

What is PCI?

PCI (Percutaneous Coronary Intervention) is a procedure to open narrowed or blocked heart arteries, often using a small balloon and a stent (a tiny mesh tube) to keep the artery open.

What's the difference between FFRangio and pressure wire?

Both help doctors decide if a blockage needs treatment. A pressure wire uses a direct measurement inside your artery, while FFRangio uses special X-ray images (angiograms) to estimate the blood flow information.

Will I know which treatment group I'm in?

Because this is a 'randomized' study, you will be assigned to either the FFRangio or pressure wire group by chance, like flipping a coin. You might not know which group you are in until after your treatment decisions are made.

How long will I be followed in the study?

You will be followed for one year after your procedure to monitor your health and any heart-related events.

What does 'non-inferior' mean?

'Non-inferior' means the study wants to show that FFRangio is at least as good as, and not worse than, the standard pressure wire method for guiding treatment.