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Iodixanol in Cerebral Angiography for Patients with Unruptured Intracranial Aneurysms

Verified siteRegistered drugNo placebo
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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 studying intracranial aneurysms, which are weak, bulging areas in the blood vessels inside the brain. The study uses iodixanol, an iodinated contrast medicine given into an artery during cerebral angiography, a type of X-ray test used to look at the blood vessels in the brain. The purpose of the study is to compare different ways of giving this contrast medicine, using lower flow rates and lower volumes, to see whether the images remain clear enough for medical review.

During the study, the contrast medicine is injected through blood vessel access in the neck area, with different injection patterns being compared with the usual method. The examination is done as part of the imaging test, and the pictures are then reviewed. The study also looks at how comfortable the procedure feels, any side effects, and how long the examination takes. No experimental drug other than iodixanol is being tested.

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

    Start of the trial procedure

    After you join the study, you undergo a diagnostic cerebral angiography, which is an imaging test of the blood vessels in the brain.

    The test is done using iodixanol, a contrast medicine that is injected into an artery. The medicine used is Visipaque 270 550 mg/ml.

    The study compares different ways of giving the contrast medicine, using reduced flow rates, reduced volumes, or both, compared with the usual protocol.

  2. Step 2

    Contrast injection during the examination

    The contrast medicine is given through catheterisation, which means placing a thin tube into an artery.

    The injection is done selectively through the internal carotid artery and the vertebral artery, which are blood vessels that supply the brain.

    The dose listed for the study product is 25 ml of solution for injection, given by intra-arterial use.

    The exact injection protocol may vary between the study methods, but the trial compares these approaches with the standard protocol used in the hospital.

  3. Step 3

    Image acquisition during the examination

    Images are taken after each injection.

    Both 2D and 3D images are assessed. 2D means two-dimensional images, and 3D means three-dimensional images.

    The main purpose is to check whether the images are clear enough to be used for the evaluation of unruptured intracranial aneurysms, which are balloon-like areas in brain blood vessels that have not burst.

  4. Step 4

    Comfort check during the procedure

    At the beginning of the procedure, your discomfort is assessed orally by a radiographer or nurse using a simple verbal scale called EVS (Échelle Verbale Simple).

    The EVS uses a score from 0 to 4, where the score reflects how much discomfort you feel.

    Your discomfort is checked again after each injection and image acquisition.

  5. Step 5

    Image review and comparison

    Radiographers review the images and decide whether each image is exploitable or non-exploitable. In this study, exploitable means usable for medical evaluation.

    An interventional neuroradiologist also reviews the images. An interventional neuroradiologist is a doctor who specializes in imaging and procedures for the brain and blood vessels.

    The trial compares the assessments made by radiographers and neuroradiologists, including how consistent these assessments are across reviewers.

  6. Step 6

    End-of-examination assessments

    At the end of the examination, your satisfaction is assessed using a SAPS questionnaire.

    Side effects are recorded, and the highest level of each side effect is noted.

    The study also records the total examination time, including the time for each injection and image acquisition, as well as any repeated attempts needed to obtain usable images.

Who can join the trial?

10 criteria

  • Be an adult at the time of consent, meaning 18 to 80 years old.
  • Be scheduled to have a diagnostic cerebral angiography as part of routine care. This is an imaging test of the brain blood vessels using contrast dye.
  • The angiography must be for either initial evaluation of a suspected or already found intracranial aneurysm on non-invasive imaging, or for follow-up of one or more intracranial aneurysms, whether they have been treated or not.
  • Be conscious and oriented, meaning awake, aware of time and place, and able to cooperate during the procedure.
  • Be able to undergo the procedure under simple local anesthesia, meaning numbing medicine is used only in the area where the procedure is done.
  • Be able to understand the study purpose and provide a dated, signed informed consent form, which is the written agreement to take part in the study.
  • Be able to answer questions asked orally or in writing.
  • Be able to understand French or speak French.
  • If the participant is a woman who can become pregnant, have a negative serum β-HCG test at the inclusion visit. This is a blood test used to check for pregnancy.
  • Be covered by a social security health insurance plan.

Who cannot join the trial?

7 criteria

  • Having an emergency cerebral angiography (an urgent brain blood vessel imaging test).
  • Having other neurovascular conditions in addition to the aneurysm, such as an AVM (arteriovenous malformation, an abnormal tangle of blood vessels) or an AVF (arteriovenous fistula, an abnormal direct connection between an artery and a vein).
  • Having any contraindication to Visipaque®, meaning a reason why this contrast dye cannot be used safely, such as an allergy or another medical risk.
  • Being pregnant or breastfeeding.
  • Having a physical or psychological condition that requires sedation (medicine to make the person sleepy and relaxed) or general anaesthesia (medicine that makes the person completely unconscious) for the procedure.
  • Having communication disorders or cognitive disorders, meaning problems with speaking, understanding, memory, thinking, or decision-making.
  • Being an incapable participant under legal protection measures, such as curatorship, guardianship, judicial protection, future protection mandate, or family authorization.
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Investigated drugs

Visipaque is an iodinated contrast dye used during cerebral angiography. It is injected directly into the arteries to help make the blood vessels in the brain easier to see on X-ray images. In this trial, it is part of the imaging procedure being studied, so doctors can compare how well different injection methods show unruptured brain aneurysms.

What is already known about the treatment

Visipaque 270 (iodixanol) - Iodixanol is given as a liquid injection into an artery, usually during imaging tests such as cerebral angiography, where it helps doctors see blood vessels clearly on X-ray pictures. It is a nonionic, iodine-based contrast medicine that is widely used in medical practice and well described in the medical literature for helping diagnose problems with blood vessels, including unruptured intracranial aneurysms. At the molecular level, it works by containing iodine atoms that absorb X-rays, which makes the blood vessels stand out on the image; it does not treat the aneurysm itself but improves the quality of the scan. It is classified as an iodinated contrast agent used for diagnostic imaging.

Investigated diseases

Intracranial aneurysm - A localized bulging or ballooning of a blood vessel inside the skull caused by a weakened vessel wall. It often develops slowly over time and may remain stable or gradually enlarge. Some aneurysms change in shape or size as the vessel wall weakens further.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524884-18-01Protocol code9882Estimated enrolment244 patientsSponsorLes Hopitaux Universitaires De Strasbourg

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