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RecruitingNAINTERVENTIONAL

The PIONEER-IV Study is Comparing Clinical Outcomes Between Angiography-derived Physiology Guidance to Usual Care in an All-comers PCI Population With Unrestrictive Use of the HT Supreme Sirolimus-eluting Stent

This study, called PIONEER-IV, is for people with coronary artery disease. It compares two methods of guiding the placement of stents (small tubes that keep arteries open) in the heart. One method uses special imaging to measure blood flow in your arteries, while the other uses the usual care doctors provide. All patients in the study will receive a specific type of stent and a particular medication plan afterwards to prevent blood clots. The goal is to see if one guidance method leads to better health results for patients over time, including those who might have a higher risk of bleeding.

At a glance

Status
Recruiting
Phase
NA
Sponsor
National University of Ireland, Galway, Ireland
Enrolment target
2,540
Start
12 Nov 2021
Estimated completion
01 Jan 2029

What is this study about?

The PIONEER-IV study is investigating how to best treat coronary artery disease, a condition where the blood vessels supplying your heart become narrowed or blocked. When this happens, a procedure called PCI (Percutaneous Coronary Intervention) is often performed. This involves inserting a stent, a small mesh tube, to hold the artery open and improve blood flow. This study is specifically looking at different ways doctors decide where to place these stents.

Researchers are comparing two main approaches. One approach uses advanced imaging techniques during the procedure to precisely measure blood flow and pressure within your arteries. This helps doctors see exactly which narrowings are significantly affecting blood flow. The other approach involves the standard methods doctors currently use to guide stent placement. All patients in the study will receive a specific type of stent called an HT Supreme sirolimus-eluting stent. Researchers anticipate enrolling over 2500 patients to ensure they get reliable results.

The main aim of the study is to see if using these advanced imaging techniques to guide the stent procedure leads to better health outcomes for patients compared to current standard practice. This includes looking at how well the stents work and if there are fewer complications. This is an important study because it could help doctors decide on the most effective way to treat coronary artery disease, potentially improving the lives of many people.

Key takeaways

  • Compares two ways to guide heart stent procedures.
  • Aims to improve outcomes for people with coronary artery disease.
  • Involves a specific type of stent and blood-thinning medication plan.
  • Patients are randomly assigned to a treatment group.
  • Participation requires follow-up visits and assessments.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must have coronary artery disease, which means you have narrowed heart arteries. You would also need at least one blockage that's 50% or more narrowed, and that blockage should be in an artery big enough (at least 2.25 mm wide) for a stent. You'll need to understand what the study involves and agree to take part by signing a consent form. You'll also need to be willing to come to all the follow-up appointments.

However, there are some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you are allergic to any of the medicines or materials used in the stents. You also can't participate if you plan to have a major operation within 12 months that would require you to stop taking blood-thinning medication. People with certain severe existing medical conditions that might shorten their life to less than 3 years, or those with a history of bleeding in the brain or active bleeding, are also not eligible.

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.

  1. Do you have coronary artery disease?
  2. Do you have at least one heart artery blockage of 50% or more?
  3. Are you able to take aspirin and ticagrelor?
  4. Are you not pregnant or breastfeeding?
  5. Do you not have a life expectancy of less than 3 years due to a medical condition?
  6. Do you not have a history of bleeding in the brain?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two groups: either the group receiving stent guidance using special imaging, or the group receiving usual care guidance. You won't know which group you're in, but your doctors will. After your stent procedure, you'll take two types of blood-thinning medication (aspirin and ticagrelor) for one month. After that, you'll take only ticagrelor for the next 11 months. At the one-year mark, your doctor will decide if you switch to just aspirin or continue with what they think is best. The study will involve regular check-ups and assessments to monitor your health and the success of the treatment. The exact number and timing of these follow-up visits will be explained to you in detail.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving an imaging-guided stent procedure, which some research suggests could lead to better outcomes. However, there's also the chance you'll receive standard care, which is already a proven treatment. All medical procedures carry risks, and stent placement is no different; potential risks include bleeding, infection, and rare complications related to the procedure or the medications. You will be closely monitored for any side effects. It's important to remember that joining a study is always voluntary, and you have the right to withdraw at any time without affecting your future medical care.

Locations (19)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • ASZ Aalst
    Verified postcode
    Aalst, Belgium· Recruiting
  • OLVZ Aalst
    Verified postcode
    Aalst, Belgium· Recruiting
  • Imelda Ziekenhuis
    Verified postcode
    Bonheiden, Belgium· Recruiting
  • CHU Charleroi
    Verified postcode
    Charleroi, Belgium· Recruiting
  • Jessa Hospital Hasselt
    Verified postcode
    Hasselt, Belgium· Recruiting
  • University Hospital Galway
    Verified postcode
    Galway, Ireland· Recruiting
  • OLVG Amsterdam
    Verified postcode
    Amsterdam, Netherlands· Recruiting
  • Medisch Spectrum Twente, Thoraxcentrum, Endchede
    Verified postcode
    Enschede, Netherlands· Recruiting
  • UMC Groningen
    Verified postcode
    Groningen, Netherlands· Recruiting
  • Medisch Centrum Leeuwarden
    Verified postcode
    Leeuwarden, Netherlands· Recruiting
  • Maasstad Ziekenhuis
    Verified postcode
    Rotterdam, Netherlands· Recruiting
  • Den Haag Ziekenhuis
    Verified postcode
    The Hague, Netherlands· Recruiting

Common questions

What is coronary artery disease?

It's a condition where the blood vessels that supply your heart become narrow or blocked, making it harder for your heart to get enough blood.

What is a stent?

A stent is a tiny mesh tube that doctors place inside a narrowed artery to hold it open and help blood flow more easily.

Will I know which treatment I'm getting?

No, you won't know if you're in the group getting special imaging guidance or the usual care group. This helps make the study results fair.

What are blood thinners?

These are medicines that help prevent blood clots from forming inside your arteries, especially after a stent procedure.

Can I leave the study if I change my mind?

Yes, you have the right to stop participating in the study at any time, and it won't affect your medical care.

How to find out more

Patrick W Serruys, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "The PIONEER-IV Study is Comparing Clinical Outcomes Between …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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