Active not recruitingNAINTERVENTIONAL

Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures

This study, called IVUS-CHIP, is looking at how best to treat complex blockages in the heart's arteries with stents. When doctors put in a stent, they need to see inside the artery to guide it. This trial compares two imaging methods: a tiny ultrasound probe (Intravascular Ultrasound, or IVUS) and standard X-ray imaging (angiography). The main goal is to see if using IVUS guidance leads to fewer future problems like heart attacks, the need for more procedures on the same blockage, or cardiac death, compared to the X-ray guided method. We hope the study will show which method gives patients with complex coronary lesions the best long-term outcomes after their stent procedure.

At a glance

Status

Active not recruiting

Phase

Sponsor

ECRI bv

Enrolment target

2,020

Start

02 Nov 2021

Estimated completion

30 Mar 2026

Complex Coronary Lesions

What is this study about?

When doctors need to put a stent into one of your heart's arteries to open up a blockage, they need a clear way to see what they are doing. This study is comparing two important methods doctors use to guide these procedures, especially for people with trickier, 'complex' blockages.

The first method is called Intravascular Ultrasound, or IVUS for short. This involves threading a very small ultrasound device into the artery. It gives doctors a super-detailed, 3D view from inside the artery. The second method uses standard X-ray imaging, called angiography. This method creates flat 2D pictures of your arteries. Both methods are currently used in hospitals, but we want to understand if one is clearly better for people with complex blockages to help them avoid problems in the future.

This research aims to find out if IVUS guidance helps prevent serious issues like future heart attacks, the need for another procedure on the same blockage, or heart-related death. The study involves many patients across several European countries, and they will be randomly assigned to receive either IVUS-guided or angiography-guided stent procedures. Doctors will then follow their health for at least two years to see which approach leads to better long-term results.

Key takeaways

This study compares two ways to guide stent procedures for complex heart blockages.
It aims to find out if using a special ultrasound (IVUS) inside the artery leads to better long-term results than standard X-ray imaging (angiography).
Participation involves being randomly assigned to one of the two guidance methods during your stent procedure.
Your health will be monitored for at least two years after the procedure.
The goal is to improve treatment for patients with complex heart artery issues worldwide.

Who may be eligible?

You might be able to join this study if you are 18 years or older and need a stent procedure for a complex blockage in your heart arteries. This could include blockages that are very hard, in tricky locations, difficult to treat, or if you need help from a special heart pump during the procedure. You would also need to have symptoms like chest pain (stable or unstable angina) or a recent, less severe heart attack. The specific stents used in the study also need to be suitable for your condition.

To be considered, you must understand all aspects of the study, be able to follow the study's instructions, and agree to participate through informed consent. This means a doctor or nurse will explain everything to you, and you'll have time to ask questions before deciding.

However, you cannot join the study if you've recently had a severe type of heart attack (STEMI) or are in cardiogenic shock (a serious heart condition). You also can't join if you have certain severe heart valve problems, need IVUS for safety reasons before the procedure, have known allergies to the stent materials or certain medications (like blood thinners or X-ray dye), or if you have other serious health problems that mean you're not expected to live for at least another year. Participating in another clinical trial at the same time might also prevent you from joining.

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 need a stent procedure for a complex heart blockage (e.g., very hard, in a tricky spot, or very long)?
Are you able to attend follow-up appointments and understand what's involved?
Do you have stable chest pain, unstable chest pain, or have you had a recent modest heart attack?
Do you NOT have severe allergies to common heart medications or X-ray dyes?
Are you NOT currently part of another clinical trial that isn't finished yet?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups: either your stent procedure will be guided by an ultrasound device (IVUS) or by standard X-ray imaging (angiography). You won't get to choose which group you are in, as this is done by chance to make the study fair.

The stent procedure itself will be like any other, but with either the IVUS or angiography guidance. After your procedure, the study team will follow your health for at least two years. This will involve scheduled check-ups, which might include clinic visits, phone calls, or reviewing your medical records, to monitor your recovery and long-term health. You'll continue to receive your usual medical care and medications as advised by your own doctors throughout this time.

Potential risks and benefits

Participating in this study might offer the potential benefit of closer monitoring thanks to the regular follow-ups. You'd also contribute to medical knowledge that could help future patients. However, there are potential risks, broadly similar to any stent procedure, and those linked to the specific imaging techniques. For example, some people might have reactions to the X-ray dye or medications. While both guiding methods are standard, there's no guarantee that one will be better for you personally. You have the right to withdraw from the study at any time, for any reason, and this will not affect the quality of your future medical care.

Locations (37)

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

OLVZ
Verified postcode
Aalst, Belgium
CHU
Verified postcode
Charleroi, Belgium
ZOL Sint-Jan
Verified postcode
Genk, Belgium
University Hospital Gasthuisberg
Verified postcode
Leuven, Belgium
Clinique Saint-Augustin
Verified postcode
Bordeaux, France
Cardiovascular Institute of Grenoble, GHM
Verified postcode
Grenoble, France
Hopital Privé Jacques Cartier
Verified postcode
Massy, France
Centre Cardiologique du Nord Saint-Denis
Verified postcode
Saint-Denis, France
CHU
Verified postcode
Toulouse, France
Clinique Pasteur
Verified postcode
Toulouse, France
CHRU Tours - HopitalTrousseau
Verified postcode
Tours, France
Segeberger Kliniken
Verified postcode
Bad Segeberg, Germany

Common questions

What is a 'complex coronary lesion'?

This means a blockage in your heart's arteries that is particularly tricky to treat, perhaps because it's very hard, in a difficult spot, or very long. Our study aims to discover the best way to treat these specific types of blockages.

What's the difference between IVUS and angiography?

IVUS uses a tiny ultrasound camera inside your artery for a detailed 3D view. Angiography uses X-rays and a special dye to show your arteries as 2D pictures from the outside. Both help doctors guide stent placement.

Will I know which treatment group I'm in?

Yes, your doctor will know whether your procedure is guided by IVUS or angiography. However, for the study to be fair, you will be randomly placed into one of the two groups, like flipping a coin.

How long will I be involved in the study?

After your stent procedure, you will be followed up for at least two years to track your progress and health outcomes. This involves checking in with the study team at specific times, which may be in person or over the phone.

Can I leave the study if I change my mind?

Yes, you can leave the study at any point and for any reason. Your decision will not affect the quality of your healthcare, and your doctors will continue to look after you.