A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)
This study, called PeriPREVENT, is testing a new approach for people undergoing a common procedure to improve blood flow in their leg arteries. Normally, an X-ray dye (called contrast media) is used to help doctors see the arteries, but this dye can sometimes cause kidney problems, especially for those already at risk. This research aims to see if using an automated carbon dioxide (CO2) gas injection system instead of, or in combination with, the dye can prevent serious kidney issues in the 90 days following the procedure. It's a large study, comparing this new method against the standard approach, to find a safer way for patients who need these leg artery interventions.
At a glance
What is this study about?
Imagine you have problems with blood flow in your legs, often called ‘peripheral vascular disease’. To help improve this, doctors might perform a procedure called a peripheral vascular intervention (PVI). During this procedure, doctors often use a special liquid dye, called an iodinated contrast medium, to help them see your blood vessels clearly on X-ray images. While this dye is very helpful, it can sometimes affect the kidneys, especially in people who are already at a moderate risk for kidney issues.
This study is trying to find a safer way to do these leg artery procedures. It's looking at whether using carbon dioxide (CO2) gas, injected automatically, can replace some or all of the usual X-ray dye. The main goal is to protect your kidneys by reducing the amount of dye used. Researchers want to see if this new approach can prevent serious kidney problems for up to 90 days after your procedure.
This is a 'Phase 3' trial, meaning it's a major step in testing this new method. Half the patients in the study will receive the standard procedure with the usual X-ray dye, while the other half will have their procedure using this new CO2 gas injection method, with the dye only used if absolutely necessary. All participants will be followed up for a year to see how they are doing.
Key takeaways
- This study evaluates if using CO2 gas can be a safer way to do leg artery procedures for people at risk of kidney problems.
- It compares a new CO2-based method to the standard method using X-ray dye.
- The main goal is to protect your kidneys from damage that can sometimes occur with the X-ray dye.
- Participation involves either the new CO2 method or the standard method, decided by chance.
- You will be closely monitored for 12 months, especially for kidney health.
- This is a large, important study aiming to improve patient safety during common leg artery procedures.
Who may be eligible?
This study is looking for adults aged 18 or older who have symptoms of poor circulation in their legs and are scheduled for a procedure on the arteries below their groin. You might be suitable if you have symptoms ranging from pain when walking to more severe issues where blood flow is very low.
You would also need to have a moderate risk of experiencing kidney problems from the standard X-ray dye, as determined by your doctors and a specific risk score. Importantly, your kidneys should not be in very advanced stages of disease or rapidly getting worse. Doctors need to agree that both the standard procedure and the CO2-assisted procedure would be possible for you.
However, some people won't be able to join. This includes if you are very anxious, need full general anaesthesia, have a short life expectancy (less than a year), or are completely unable to walk. You also can't participate if you have known severe kidney problems, have recently had other procedures involving X-ray dye that affected your kidneys, or are taking certain strong medications that can harm the kidneys. Other reasons include severe lung disease, certain heart defects, specific thyroid problems, severe heart failure, or known severe allergies to the X-ray dye.
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 and have leg circulation problems needing a procedure?
- Are your kidney functions stable, but you have a moderate risk of kidney issues from X-ray dye?
- Are you able to walk, and not confined to bed or very agitated?
- Do you have good overall health, without severe heart, lung, or thyroid conditions?
- Have you had recent procedures with X-ray dye that caused significant kidney changes?
- Are you allergic to X-ray dye or taking specific strong kidney-damaging medications?
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to one of two groups, like flipping a coin. One group will have their leg artery procedure using the standard X-ray dye. The other group will have their procedure using an automated CO2 gas injection system to see the arteries, with the X-ray dye only used if the CO2 doesn't provide clear enough images or if you find the CO2 uncomfortable.
After your procedure, the study team will keep in touch to check on your health, particularly your kidney function. You will have regular checks and tests. The main part of the study looks at your health for up to 90 days after the procedure, but you will continue to be followed up by the study team for a total of 12 months. There are no extra medications to take as part of this study.
Potential risks and benefits
Locations (11)
- Tirol Kliniken InnsbruckVerified postcodeInnsbruck, Austria· Recruiting
- Universitätsklinik für Innere Medizin IIVerified postcodeVienna, Austria· Recruiting
- Kreiskrankenhaus AlsfeldVerified postcodeAlsfeld, Germany· Recruiting
- Universitäts-Herzzentrum Freiburg-Bad KrozingenVerified postcodeBad Krozingen, Germany· Recruiting
- Universitätsklinikum BonnVerified postcodeBonn, Germany· Not yet recruiting
- Klinikum Chemnitz gGmbHVerified postcodeChemnitz, Germany· Not yet recruiting
- DIAKO Krankenhaus gGmbH FlensburgVerified postcodeFlensburg, Germany· Not yet recruiting
- MVZ CCB Frankfurt und Main-Taunus GbRCity onlyFrankfurt a.M., Germany· Recruiting
- Universitätsklinikum LeipzigVerified postcodeLeipzig, Germany· Recruiting
- Klinikum rechts der Isar der Technischen Universität MünchenVerified postcodeMünchen, Germany· Recruiting
- GRN - Klinik WeinheimVerified postcodeWeinheim, Germany· Recruiting
Common questions
What is 'peripheral vascular disease'?
It's a common condition where narrowed arteries reduce blood flow to your limbs, most often your legs.
What is 'iodinated contrast media'?
It's a special liquid dye used during X-rays or scans to make blood vessels and organs show up more clearly.
Why is CO2 being used instead of the dye?
CO2 gas can also help doctors see blood vessels, and it doesn't have the same potential to harm kidneys as the X-ray dye, making it a potentially safer option for some patients.
What are 'Major Adverse Kidney Events'?
These are serious problems that can happen to your kidneys, such as a drop in kidney function, after a medical procedure.
How long will I be involved in the study?
You'll be followed up for 12 months after your leg artery procedure, with closer checks for the first 90 days.
How to find out more
Sabine Steiner, Prof Dr
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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