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Study of Carbon Dioxide versus Iodine Contrast in Patients with Abdominal Aortic Aneurysm Having Fenestrated Endovascular Repair

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What is this trial about?

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

This study is looking at abdominal aortic aneurysm, which is a bulging or swelling in the main blood vessel that carries blood from the heart down through the abdomen. The study involves patients who are planned to have a procedure called fenestrated endovascular aneurysm repair, which is a way to fix this bulging blood vessel from the inside using special tubes and devices. During this procedure, doctors need to see the blood vessels clearly, and they typically use iodine contrast media, which are special liquids that help make blood vessels visible on imaging scans. The study will use different types of iodine contrast products including iohexol, iomeprol, and iodixanol, which are all injected into the blood vessels to help with imaging.

The purpose of the study is to find out if using less iodine contrast during the procedure by using carbon dioxide gas instead when possible can reduce kidney problems after the surgery compared to the usual approach. Kidney problems can sometimes happen after this type of procedure because the contrast material can affect how the kidneys work. The study will compare two different strategies: one that tries to use carbon dioxide for imaging whenever possible to reduce the amount of iodine contrast needed, and one that uses the standard amount of iodine contrast.

During the study, patients will be randomly assigned to receive one of these two imaging strategies during their planned procedure. The doctors will monitor kidney function by checking blood tests and urine output after the surgery to see if there are any signs of kidney injury. Patients will be followed for up to three years after the procedure with regular check-ups, imaging scans, and questionnaires about their quality of life and recovery. The study will also track other important outcomes such as the success of the surgery, any complications that occur, survival rates, and changes in kidney function over time.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Consent and screening

    Your participation begins when you provide written consent to join this trial.

    If you are a woman of childbearing age, a pregnancy test will be performed. A negative result is required to participate. After joining, you will need to use highly effective birth control methods until the trial ends.

    The trial involves treatment for an abdominal aortic aneurysm, which is a bulge in the main blood vessel that carries blood from the heart to the abdomen and lower body.

  2. Step 2

    Pre-procedure assessment

    Before the procedure, your quality of life will be assessed using a questionnaire called EQ-5D-5L.

    Your cognitive function will be evaluated using a test called MoCa, which assesses memory and thinking abilities.

    Your kidney function will be measured through blood tests that check serum creatinine levels, which indicate how well your kidneys are filtering waste from your blood.

  3. Step 3

    Surgical procedure

    You will undergo a planned procedure called FEVAR, which stands for fenestrated endovascular aneurysm repair. This is a minimally invasive surgery to repair the aneurysm in your aorta.

    During the procedure, imaging will be used to guide the surgery. Depending on the treatment group assigned to you, different contrast agents may be used to visualize your blood vessels.

    The contrast agents that may be used include iohexol, iomeprol, or iodixanol. These are substances injected into your blood vessels to make them visible on imaging scans.

    Some patients may receive carbon dioxide as an alternative contrast agent to reduce exposure to iodine-based contrast.

    During the procedure, the quality of the images, any leaks around the graft, radiation exposure, and absorbed dose will be monitored.

  4. Step 4

    Early post-operative period

    After the procedure, your kidney function will be closely monitored to check for acute kidney injury, which is a sudden decrease in kidney function.

    This will be assessed using the RIFLE classification and KDIGO classification, which are systems that grade kidney injury based on blood test results and urine output.

    Your urine output will be measured regularly during this period.

    Two days after the procedure, your recovery will be assessed using the Swedish Quality of Recovery Scale.

    Any complications or adverse events will be recorded until you are discharged from the hospital.

  5. Step 5

    Discharge and one-month follow-up

    At discharge, your quality of life will be assessed again using the EQ-5D-5L questionnaire.

    One month after the procedure, you will have a follow-up visit that includes a CT scan, which is an imaging test that creates detailed pictures of your blood vessels and the repair.

    Your cognitive function will be evaluated again using the MoCa test.

    Your quality of life will be assessed once more using the EQ-5D-5L questionnaire.

    The success of the surgery will be evaluated based on clinical and imaging results.

  6. Step 6

    One-year follow-up

    One year after the procedure, you will have another follow-up visit.

    A CT scan will be performed to assess the repair and check for any complications.

    Your kidney function will be evaluated by measuring eGFR, which stands for estimated glomerular filtration rate. This is a calculation based on blood tests that shows how well your kidneys are working.

    The presence of chronic kidney disease, which is long-term kidney damage, will be assessed using the National Kidney Foundation classification.

    Your quality of life will be measured using the EQ-5D-5L questionnaire.

    Any adverse events, need for additional procedures, and survival status will be recorded.

  7. Step 7

    Two-year follow-up

    Two years after the procedure, you will have another follow-up visit.

    A CT scan will be performed to monitor the repair.

    Your kidney function will be assessed again by measuring eGFR.

    Any changes in your chronic kidney disease stage will be recorded.

    Your quality of life will be measured using the EQ-5D-5L questionnaire.

    Any adverse events, need for additional procedures, and survival status will be documented.

  8. Step 8

    Three-year follow-up

    Three years after the procedure, you will have a final follow-up visit.

    A CT scan will be performed to assess the long-term success of the repair.

    Your kidney function will be evaluated once more by measuring eGFR.

    Any progression of chronic kidney disease will be assessed.

    Your quality of life will be measured using the EQ-5D-5L questionnaire.

    Any adverse events, need for additional procedures, survival status, and cause of death if applicable will be recorded.

    This marks the completion of your participation in the trial.

Who can join the trial?

4 criteria

  • You must provide written consent to take part in the trial.
  • You must have a planned non-emergency procedure called FEVAR, which is a treatment for a bulge in the main artery in your abdomen (a condition called an abdominal aortic aneurysm). This procedure must be scheduled within six months and will use a specially made tube-like device made of stainless steel and polyester fabric.
  • You must be at least 18 years old.
  • If you are a woman who is able to become pregnant, you must have a negative pregnancy test before joining the trial and must use highly effective methods to prevent pregnancy throughout the trial.

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified for this clinical trial in the available information.
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Investigated drugs

  • Carbon dioxide

    is a gas that can be used to help doctors see blood vessels during surgery. In this trial, it is being tested as an alternative way to visualize arteries during the repair procedure, with the goal of reducing the amount of iodine contrast dye that patients are exposed to.

  • Iodine contrast medium

    is a special dye that is injected into blood vessels to make them visible on X-ray images during surgery. This is the standard method currently used to help doctors see the blood vessels clearly while performing the repair procedure.

What is already known about the treatment

  • Carbon Dioxide

    Carbon dioxide is a gas that can be used as a contrast agent during imaging procedures to help doctors see blood vessels on X-ray screens. In this clinical trial, it is being tested as an alternative to traditional iodine-based contrast dyes during a complex surgical procedure to repair abdominal aortic aneurysms (bulges in the main artery of the abdomen). The goal is to determine whether using carbon dioxide instead of iodine contrast can reduce the risk of kidney injury that sometimes occurs after this type of surgery. Carbon dioxide works by temporarily displacing blood in the arteries, creating a visual contrast that allows surgeons to see the blood vessel structure during the procedure.

  • Iodine Contrast Medium

    Iodine contrast medium is a liquid dye containing iodine that is injected into blood vessels to make them visible on X-ray and imaging scans during medical procedures. It is the standard contrast agent used in vascular surgeries, including the repair of abdominal aortic aneurysms, because it provides clear images of blood vessels and helps guide surgical instruments. However, iodine contrast can sometimes cause kidney damage, especially in patients who receive large amounts during complex procedures. This clinical trial is comparing the standard use of iodine contrast with a strategy that minimizes its use by substituting carbon dioxide gas when possible.

Investigated diseases

Abdominal Aortic Aneurysm – An abdominal aortic aneurysm is an abnormal bulging or widening of the main blood vessel that carries blood from the heart through the abdomen. The aorta's wall weakens over time, causing it to expand like a balloon in the abdominal area. This condition typically develops slowly over many years without causing noticeable symptoms in most people. As the aneurysm grows larger, some individuals may experience a pulsating feeling near the navel, deep constant pain in the abdomen or on the side of the abdomen, or back pain. The enlargement can continue to progress gradually if left unaddressed. Risk factors include aging, smoking, high blood pressure, and a family history of the condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-521795-58-00Estimated enrolment293 patientsSponsorRegion Skane

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