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Study on Preventing Kidney Problems in Peripheral Arterial Disease Patients Using Carbon Dioxide and Iopamidol, Iomeprol, and Iopromide During Vascular Procedures

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Peripheral Arterial Disease (PAD), which affects blood flow in the arteries outside of the heart and brain, often in the legs. The study is exploring a new approach to reduce the risk of kidney problems that can occur after certain medical procedures. This approach involves using a special gas called Carbon Dioxide (CO2) instead of traditional iodinated contrast during procedures to open up blocked arteries in the legs. The goal is to see if this method can help prevent serious kidney issues, known as Major Adverse Kidney Events (MAKE), in patients who are at a higher risk of kidney damage from these procedures.

The trial will include several different types of contrast solutions, such as Solutrast, Imeron, Ultravist, VISIPAQUE, ACCUPAQUE, and Optiray, which are used to improve the visibility of blood vessels during imaging tests. These solutions contain substances like iopamidol, iomeprol, iopromide, iodixanol, iohexol, and ioversol. The study will compare the effects of using these traditional contrast solutions with the new CO2 method to determine which is more effective in preventing kidney problems.

Participants in the study will undergo a procedure called infrainguinal peripheral vascular intervention (PVI), which is a treatment for blocked arteries in the legs. The study will monitor the participants for up to 90 days after the procedure to assess the occurrence of kidney-related issues. The aim is to find out if the CO2 method can reduce the risk of kidney damage compared to the use of traditional contrast solutions. This research is important for improving the safety of medical procedures for patients with PAD who are at risk of kidney problems.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose, procedures, and potential risks and benefits. You will be required to provide written informed consent, confirming your understanding and willingness to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes evaluating your medical history, current health status, and specific criteria such as your risk of kidney injury and the condition of your peripheral arteries.

  3. Step 3

    Pre-procedure preparation

    Before the procedure, you will undergo routine tests to assess your kidney function and overall health. These tests help ensure that you are in a suitable condition to proceed with the intervention.

  4. Step 4

    Procedure day

    On the day of the procedure, you will receive an injection of a contrast medium, which is a special dye used to improve the visibility of blood vessels during imaging. The contrast medium may include substances such as iopamidol, iomeprol, or iodixanol, administered through an intravenous (IV) injection or infusion.

    The procedure involves using automated carbon dioxide (CO2) injection to minimize the amount of contrast medium needed. This approach aims to reduce the risk of kidney injury.

  5. Step 5

    Post-procedure monitoring

    After the procedure, you will be monitored for any immediate reactions or complications. Your kidney function will be closely observed to detect any signs of acute kidney injury.

  6. Step 6

    Follow-up visits

    You will have scheduled follow-up visits to assess your recovery and kidney health. These visits will occur up to 90 days after the procedure to monitor for any major adverse kidney events.

    During these visits, additional tests may be conducted to evaluate your kidney function and ensure that no significant decline has occurred.

Who can join the trial?

6 criteria

  • Have symptomatic peripheral arterial disease (PAD), which means you have symptoms due to poor blood flow in your legs. This can be either sudden symptoms or long-term symptoms.
  • Plan to have a procedure called a peripheral vascular intervention (PVI) on the arteries below your groin area, specifically in the thigh or lower leg.
  • Have an increased risk of kidney injury from the contrast dye used in medical imaging. This is determined by a risk score of 5 or more points and a kidney function test result (eGFR) of less than 60.
  • Both treatment strategies using imaging seem possible according to the doctor's judgment.
  • Be 18 years or older.
  • Provide written informed consent, which means you agree to participate after understanding the study details.

Who cannot join the trial?

10 criteria

  • Patients with a history of **severe allergic reactions** to contrast media. Contrast media are substances used in medical imaging to help highlight structures in the body.
  • Patients with **severe kidney disease**. This means the kidneys are not working well enough to filter waste from the blood.
  • Patients who have had a **kidney transplant**. This is when a person receives a new kidney from a donor.
  • Patients with **severe heart failure**. This is a condition where the heart cannot pump blood effectively.
  • Patients who are **pregnant** or **breastfeeding**.
  • Patients who are currently participating in another clinical trial.
  • Patients with **uncontrolled high blood pressure**. This means blood pressure that is not managed well with medication or lifestyle changes.
  • Patients with **severe liver disease**. This is when the liver is not functioning properly.
  • Patients with **active infection**. This means having an ongoing infection that is not yet treated or resolved.
  • Patients with **blood clotting disorders**. These are conditions that affect the blood's ability to clot properly.
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Investigated drugs

Carbon Dioxide (CO2) Injection is a method used in medical procedures to help doctors see blood vessels more clearly. In this trial, it is used as an alternative to traditional contrast dyes that contain iodine. The goal is to reduce the risk of kidney problems that can occur when iodine-based dyes are used, especially in patients who already have a higher risk of kidney issues. By using CO2, doctors hope to perform the necessary procedures while keeping the kidneys safe.

What is already known about the treatment

Carbon Dioxide (CO2) Injection – This medication is administered as an injection and is used during certain types of vascular procedures. It is currently being studied in clinical trials to see if it can help reduce the risk of kidney problems in patients undergoing procedures to treat Peripheral Arterial Disease (PAD). The main therapeutic use being investigated is its potential to prevent kidney damage that can occur from using traditional contrast dyes. At the molecular level, CO2 acts as a contrast agent by creating a clear image of blood vessels without the need for iodinated contrast, which can be harmful to the kidneys. It is classified as a contrast medium in pharmacology.

Investigated diseases

Peripheral Arterial Disease (PAD) – Peripheral Arterial Disease is a condition where the arteries that supply blood to the limbs, usually the legs, become narrowed or blocked. This narrowing is typically due to atherosclerosis, which is the buildup of fatty deposits on the artery walls. As the disease progresses, it can lead to reduced blood flow, causing symptoms such as leg pain, cramping, or fatigue, especially during physical activities like walking. Over time, the reduced blood flow can result in more severe symptoms, including pain at rest, non-healing wounds, or ulcers on the feet or toes. In advanced stages, PAD can lead to critical limb ischemia, where the blood flow is so restricted that it threatens the viability of the limb. The progression of PAD can vary, with some individuals experiencing slow progression and others facing rapid worsening of symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512876-37-00Protocol codePeriPREVENTEstimated enrolment1 960 patientsSponsorUniversitaet Leipzig

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