All studies
Active not recruitingNAINTERVENTIONAL

Permanent Intracranial Stenting for Acute Ischemic Stroke Related to a Refractory Large Vessel Occlusion

When someone has a severe stroke, doctors often try to remove the clot causing it. But sometimes, this doesn't work, which can lead to very poor outcomes. This study is for people who have had such a stroke, caused by a blocked major blood vessel, and where the first attempt to remove the clot was unsuccessful. Researchers are looking into whether putting a small, permanent tube (called a stent) in the brain's blood vessel, combined with the best standard medical care, is more effective than just providing the best medical care on its own. The aim is to see if this stent can improve recovery and reduce the risk of death, without causing too many new problems.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrolment target
346
Start
08 Nov 2023
Estimated completion
01 Aug 2027

What is this study about?

When an urgent stroke happens, it's often because a blood clot is blocking a major blood vessel in the brain. Doctors frequently try to remove this clot using a procedure called mechanical thrombectomy. While this treatment is often successful, sometimes the clot can't be fully removed, or it reappears quickly. This is a very serious situation for patients, as it can lead to severe disability or even death. This study focuses on these difficult cases, aiming to find a better way to help.

Researchers are investigating a treatment called intracranial stenting. This involves placing a tiny, permanent tube (a stent) inside the blocked blood vessel in the brain. This stent is designed to hold the vessel open and help blood flow properly again. This method has been used successfully for similar problems in the heart, but using it in the brain is more complex because the brain is very sensitive and there's a higher risk of bleeding, especially since patients need to take blood-thinning medicines with the stent.

This study compares two approaches for patients with these challenging strokes: one group will receive the permanent stent along with the best medical care, while the other group will receive only the best medical care without the stent. By comparing these groups, doctors hope to understand if the stent can significantly improve a patient's chances of recovery, reduce the risk of death, and whether the benefits outweigh any potential risks, like bleeding in the brain. The goal is to provide the best possible care for people facing the most severe stroke outcomes.

Key takeaways

  • This study is for severe strokes where initial clot removal attempts didn't work.
  • It compares placing a permanent stent in the brain's blood vessel with standard care.
  • The goal is to improve recovery and reduce death from these difficult strokes.
  • Stents in the brain carry a risk of bleeding, due to necessary medication.
  • Participation means receiving either new treatment or standard care, decided by chance.

Who may be eligible?

This study is looking for adults aged 18 or over who have recently had a severe type of stroke. This stroke must be due to a blockage in a major blood vessel in the brain, and doctors must have tried to remove the clot, but it didn't fully clear, or it blocked up again very quickly. Also, the stroke must be in specific areas of the brain.

There are also some important health conditions that would prevent someone from joining the study. For example, if you've had a recent brain bleed or have conditions that mean you can't take certain blood-thinning medications, you wouldn't be able to take part. Also, if you have other serious health problems that might make the treatment difficult or prevent you from getting better, you might not be eligible. Finally, you must have been able to live independently before your stroke.

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.

  1. Are you over 18 years old?
  2. Did you have a stroke due to a major brain blood vessel blockage?
  3. Did doctors try to remove the clot, but it didn't work completely or reclogged quickly?
  4. Were you able to live independently before your stroke?
  5. Do you not have certain pre-existing conditions like recent brain bleeds or severe kidney issues?
  6. Can you take blood-thinning medications?
Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the standard medical care, or standard medical care plus a procedure to place a permanent stent in your brain. This decision would be made randomly, like flipping a coin. You would have various checks and scans to see how you're recovering. While the exact number of hospital visits or follow-up appointments isn't detailed, stroke recovery often involves regular checks and rehabilitation. The study's duration isn't specified, but follow-up for stroke patients typically continues for several months to assess long-term recovery.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new treatment that could potentially improve your recovery from a very severe stroke and lower your risk of death. However, putting a stent in your brain carries risks, including a higher chance of bleeding in the brain due to the necessary blood-thinning medication. Doctors will carefully weigh your individual circumstances. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (13)

  • CHU Amiens
    Verified postcode
    Amiens, France
  • CHU Bordeaux (Pellegrin Hospital)
    Verified postcode
    Bordeaux, France
  • Henri-Mondor Hospital (APHP)
    Verified postcode
    Créteil, France
  • Henri-Mondor Hospital (APHP)
    Verified postcode
    Créteil, France
  • Bicêtre Hospital (AP-HP)
    Verified postcode
    Le Kremlin-Bicêtre, France
  • Bicêtre Hospital (APHP)
    Verified postcode
    Le Kremlin-Bicêtre, France
  • CHU Lille (Roger Salengro Hospital)
    Verified postcode
    Lille, France
  • CHU Montpellier - Gui de Chauliac
    Verified postcode
    Montpellier, France
  • CHRU de Nancy
    Verified postcode
    Nancy, France
  • Lariboisière Hospital (APHP)
    Verified postcode
    Paris, France
  • APHP • Assistance Publique des Hôpitaux de Paris, Pitié-Salpêtrière hospital
    Verified postcode
    Paris, France
  • CHU Poitiers
    Verified postcode
    Poitiers, France

Common questions

What is a 'stent'?

A stent is a tiny, mesh-like tube that doctors can place inside a blood vessel to keep it open and improve blood flow.

What does 'optimal medical care' mean?

This refers to the best standard treatments and care that doctors currently recommend for someone who has had a stroke, based on current medical guidelines.

Why might clot removal fail in a stroke?

Sometimes, the clot might be too stubborn, or the blood vessel might have a build-up of fatty material (atherosclerosis) underneath that makes it difficult to clear or causes it to block again quickly.

Will I know if I get the stent?

Yes, if you are included in the stent group, you will be aware of undergoing the procedure to place the stent.

What is 'mechanical thrombectomy'?

It's a procedure where doctors use special tools inserted into a blood vessel to physically pull out a blood clot that is causing a stroke.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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