Active not recruitingNAINTERVENTIONAL

Precise Procedural and PCI Plan (P4)

This study, called P4, is looking at two different ways to help doctors perform a procedure called PCI, which opens up blocked heart arteries. One way uses detailed 3D pictures from a special CT scan taken before the procedure. The other way uses a tiny camera (IVUS) that goes inside the artery during the procedure. We want to find out if using CT scans before PCI is just as good, or even better, than the current method using the internal camera. This could help doctors plan treatments more effectively, improve patient care, and make the procedure smoother. We'll be comparing how patients get on after their PCI using either method over several years.

At a glance

Status

Active not recruiting

Phase

Sponsor

CoreAalst BV

Enrolment target

1,090

Start

01 Apr 2022

Estimated completion

01 Oct 2026

Coronary Artery Disease

What is this study about?

When people have blockages in the arteries supplying their heart, a common treatment is a procedure called PCI (Percutaneous Coronary Intervention). This usually involves inserting a small tube with a balloon to open the artery, often followed by placing a small mesh tube called a stent to keep it open. To do this procedure well, doctors need very clear pictures of the blockage.

Traditionally, doctors might use a tiny camera called IVUS that goes inside the artery during the procedure to get this detailed view. However, new techniques using advanced CT scans taken before the procedure (called CT-guided PCI) can also provide very detailed 3D maps of the heart arteries. These maps could help doctors plan the entire procedure more accurately even before it starts, potentially making the treatment more precise and efficient.

This P4 study aims to compare these two approaches: CT-guided PCI and IVUS-guided PCI. We want to see if using the pre-procedure CT scans to guide the PCI is just as effective and safe as the current method. Findings from this study could help improve how doctors plan and perform these important heart procedures, potentially leading to better results for patients.

Key takeaways

Compares two ways to guide heart stent procedures: CT scans vs. internal camera.
Aims to find out if CT-guided planning is as good as the current method.
Looks at adults needing treatment for blocked heart arteries.
Involves a random assignment to one of the two guidance methods.
Includes follow-up appointments for up to five years.
Could help improve future heart procedures for many patients.

Who may be eligible?

This study is for adults generally aged between 18 and 79 who have blockages in their heart arteries causing problems like chest pain (angina) or who have had a mild heart attack. You would be considered if your doctor thinks you need a procedure to open these blocked arteries.

There are certain reasons why you wouldn't be able to join. For example, if you're too young or too old, have had a very serious type of heart attack recently, have severe kidney problems, or certain issues with your heart rhythm. Also, if you've already had a PCI or bypass surgery, or if the blockage is in a main heart artery, you wouldn't be able to participate. We also need to be sure you can take certain medications after the procedure for a specific time.

To be included, the blocked arteries suitable for treatment should be of a certain size, and you shouldn't have too many target blockages. You also need to be able to provide written permission (consent) to take part.

Quick self-check

Are you between 18 and 79 years old?
Do you have a blockage in your heart arteries that your doctor thinks needs a stent?
Do you have stable chest pain, or have you had a mild heart attack?
Have you *not* had a very serious type of heart attack very recently?
Do you *not* have severe kidney disease or certain heart rhythm problems?
Are you able to take specific anti-clotting medications for several months after the procedure?

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

What does participation involve?

If you decide to join this study and your doctor agrees you meet the main criteria, you would first provide your written consent. Once that's done, if it's confirmed you have a significant blockage, you would be randomly assigned to one of two groups: one where your PCI procedure is guided by detailed CT scans taken before the procedure, or one where it's guided by a tiny camera inside your artery during the procedure (IVUS).

Both types of procedures would follow a specific plan for the study. After your PCI, a special measurement called FFR will be taken to check blood flow. You'll stay in the hospital as needed and then have follow-up appointments. These will usually happen around 30 days, 12 months, and then yearly for up to five years after your procedure. These appointments will allow doctors to check your health and how well the treatment is working over time.

Potential risks and benefits

Participating in this study might offer you the potential benefit of receiving an innovative approach to your heart artery procedure, which could lead to more precise treatment. However, as with any medical procedure, there are potential risks associated with PCI, including bleeding, infection, and rare but serious complications. Being in a study also means you might have extra appointments for follow-up. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (23)

Cedars-Sinai Medical Center
Los Angeles, United States
Minneapolis Heart Institute Foundation
Minneapolis, United States
St. Francis Hospital & Heart Center
Roslyn, United States
UZ Brussels
Jette, Belgium
OLV Hospital
Aalst, Belgium
Hartcentrum ZNA Antwerp
Antwerp, Belgium
Gentofte hospital
Gentofte Municipality, Denmark
Aarhus Universitetshospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Centre Hospitalier Universitaire de Lille
Lille, France
Medical Imaging Centre, Semmelweis University
Budapest, Hungary
Azienda Ospedaliero Universitaria di Ferrara
Cona, Italy

+11 more sites — see the official record for the full list.

Common questions

What is PCI?

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

What is a CT scan?

A CT scan uses X-rays and computer processing to create detailed cross-sectional images of your body, providing much more detail than a standard X-ray.

What is IVUS?

IVUS stands for Intravascular Ultrasound. It's a medical imaging technique where a tiny ultrasound probe is inserted into an artery to create detailed pictures from inside the blood vessel.

Will I know which group I'm in?

No, you will be randomly assigned to one of the two groups, and often neither you nor your doctors will know which treatment you are receiving until after the assignment.

How long will I be part of the study?

If you join, you will be followed up for a period of up to five years after your procedure.