Active not recruitingNAINTERVENTIONAL

PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior CABG

This study, called PROCTOR, is for people who have had heart bypass surgery and now have a problem with one of their bypass grafts or original arteries. When a bypass graft isn't working well, doctors need to decide whether to treat the graft itself or fix the original artery that was bypassed. The study aims to compare these two approaches: fixing the original artery or fixing the faulty bypass graft. This is a multi-centre study across Europe, including the UK, involving about 584 patients. Researchers want to see which method leads to better health outcomes over one and five years. The goal is to find the best treatment strategy for patients with coronary artery disease after bypass surgery.

At a glance

Status

Active not recruiting

Phase

Sponsor

Amsterdam UMC, location VUmc

Enrolment target

221

Start

22 Jan 2019

Estimated completion

30 Jun 2028

Coronary Artery Disease

What is this study about?

If you've had heart bypass surgery (CABG) in the past, it means some of your heart arteries were blocked, and doctors used a blood vessel from another part of your body (a graft) to go around the blockage and restore blood flow. Over time, sometimes these bypass grafts can become less effective, or problems can develop in the original heart arteries.

When this happens, doctors often consider another procedure called Percutaneous Coronary Intervention (PCI), also known as angioplasty and stenting. This study is designed to help doctors understand the best way to use PCI in people who have had bypass surgery and now have a new problem. Should they try to fix the original heart artery that was bypassed, or should they try to fix the bypass graft itself if it's not working properly? This is an important question because knowing the best approach can lead to better health for patients.

This research, called the PROCTOR study, will compare these two treatment options. Patients will be randomly assigned to one of two groups: one group will have PCI on their original heart artery, and the other group will have PCI on their faulty bypass graft. By carefully comparing the results from both groups over several years, the researchers hope to find out which method provides the most lasting relief and prevents future heart problems.

Key takeaways

This study compares two ways to fix heart blockages after bypass surgery.
It uses a common procedure called PCI (angioplasty and stenting).
You would be randomly assigned to treat either the original artery or the bypass graft.
The study involves follow-up phone calls for five years and one extra heart scan.
It aims to find the best treatment approach for better long-term heart health.
Participation is optional, and you can stop at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have had heart bypass surgery and now have a specific type of blockage. Specifically, there needs to be a significant narrowing in one of your bypass grafts, and your medical team must agree that treating this blockage is necessary based on your symptoms or other tests.

Both the original blocked artery and the bypass graft problem must be suitable for treatment with a standard procedure using a special device called a stent. You also need to be well enough generally, without severe kidney disease, a recent large heart attack, or other serious health issues that might make the procedure too risky or affect the study results. Your doctor will carefully check all these points with you.

There are also some reasons why you wouldn't be able to join, such as if you are pregnant, have a very short expected lifespan, or have other medical conditions that make the PCI procedure unsafe for you. If your bypass surgery was very recent (less than a year ago), you also wouldn't be eligible for this particular study.

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.

Have you had heart bypass surgery in the past?
Do you have a significant narrowing in one of your bypass grafts?
Has your doctor said you need treatment for a heart blockage?
Is your original heart artery and the bypass graft blockage suitable for stenting?
Are you 18 years old or older?
Are you generally healthy, without severe kidney problems or a recent, major heart attack?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the main PROCTOR study, you will be randomly assigned to one of two groups: either you will have a special procedure (PCI) to fix your original heart artery, or you will have PCI to fix your bypass graft. This procedure is common for treating blocked arteries. After your procedure, nurses will check in with you by phone one year and five years later to see how you are doing. After three years, you'll be asked to come in for another heart imaging test (angiography) to see how your arteries look.

There's also an optional part of the study called the CCTA substudy. If you choose to join this and are selected, you'll have an extra CT scan of your heart before your PCI procedure. This involves lying still in a scanner. Another part of the study is a registry for patients who don't fit the main study criteria or prefer not to be randomised. If you join the registry, you'll have phone check-ups after one, three, and five years, but no extra tests.

Potential risks and benefits

Taking part in this study could potentially help guide future treatment decisions for people with heart problems after bypass surgery, and you would receive treatment for your condition. However, there are also risks associated with any medical procedure like PCI, including bleeding, infection, and rare but serious complications. You might also find the additional tests and follow-up appointments inconvenient. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (21)

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

University Hospital
Verified postcode
Antwerp, Belgium
Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim
Verified postcode
Antwerp, Belgium
Ziekenhuis Oost-Limburg
Verified postcode
Genk, Belgium
UZ Leuven
Verified postcode
Leuven, Belgium
Universitäts Herzzentrum
Verified postcode
Bad Krozingen, Germany
Universitair Medische Centra
Verified postcode
Amsterdam, Netherlands
Academic Medical Center
Verified postcode
Amsterdam, Netherlands
Amphia Ziekenhuis
Verified postcode
Breda, Netherlands
Catharina Ziekenhuis
Verified postcode
Eindhoven, Netherlands
Medisch Centrum Leeuwarden
Verified postcode
Leeuwarden, Netherlands
Sint Antonius Ziekenhuis
Verified postcode
Nieuwegein, Netherlands
Radboud Universitair Medisch Centrum (Radboud UMC)
Verified postcode
Nijmegen, Netherlands

Common questions

What is 'PCI'?

PCI stands for Percutaneous Coronary Intervention. It's a procedure where doctors use a tiny balloon and usually a small mesh tube called a stent to open up blocked or narrowed heart arteries.

What is a 'bypass graft'?

After bypass surgery, a bypass graft is a healthy blood vessel, taken from another part of your body, that is used to create a new path around a blocked section of your heart artery, restoring blood flow.

Will I get to choose which treatment I receive?

No, if you join the main study, a computer will randomly assign you to one of the two treatment groups (fixing the original artery or fixing the bypass graft), similar to flipping a coin.

How long will I be involved in the study?

You'll be part of the study for five years, with phone calls at one and five years, and an extra heart scan at three years.

What if my health changes during the study?

Your medical team will continue to monitor your health. If your condition changes and requires different treatment, you will receive the necessary care, and you can leave the study at any time.