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A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke

This research study is looking at a new medical tool called an Adaptive Tip Catheter (ATC). It's designed to help people who have had a type of stroke called an ischemic stroke, which happens when a blood clot blocks blood flow to the brain. The main goal is to find out if using this new catheter is both safe and works well to remove these clots. Researchers want to see if it can be a good first choice for treatment. By joining, people would be helping doctors understand better ways to treat strokes, potentially leading to better outcomes for future patients.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Neuravi Limited
Enrolment target
74
Start
02 Feb 2026
Estimated completion
31 Jul 2027

What is this study about?

This study is all about improving how doctors treat a common type of stroke called an ischemic stroke. This happens when a blood clot blocks an artery in the brain, stopping blood flow and causing damage. A key treatment involves a procedure where doctors use a thin tube, called a catheter, to go into the blood vessels and remove the clot.

The researchers in this study are testing a new kind of catheter, known as an Adaptive Tip Catheter (ATC). They want to see if this specific catheter is safe to use and if it's good at removing blood clots directly during the stroke treatment. The hope is that this new tool could make the procedure more effective and lead to better recovery for patients.

By taking part in this study, you would be helping medical professionals understand if this new catheter is a good option for treating strokes. This research is important because it could lead to better ways to help people who have had a stroke in the future.

Key takeaways

  • This study is testing a new device for stroke treatment.
  • It focuses on safety and effectiveness for removing blood clots.
  • Participation could help improve future stroke care.
  • You must meet specific health and stroke criteria to join.
  • You can withdraw from the study at any time.
  • The study aims to make stroke treatment better.

Who may be eligible?

To join this study, you would generally need to be between 18 and 90 years old and have recently had an ischemic stroke that doctors believe can be treated by going into your blood vessels. Treatment would need to start within 24 hours of when your stroke symptoms began or when you were last known to be well. Your stroke's severity and certain brain scan results (NIHSS and ASPECTS scores) would also need to meet specific levels.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if doctors think you have less than three months to live. Other reasons include certain bleeding conditions, signs of stroke in multiple parts of your brain, or if the clot is thought to be an old blockage. You also couldn't join if you have signs of recent bleeding in the brain, or if you're already in another medical study that might affect the results of this one.

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 between 18 and 90 years old?
  2. Have you recently had an ischemic stroke in the front part of your brain?
  3. Could your stroke treatment start within 24 hours of when your symptoms began?
  4. Are you *not* pregnant or breastfeeding?
  5. Do you *not* have certain bleeding problems or other serious health issues mentioned?
  6. Are you *not* currently in another medical study that might interfere?
Answer every question to see your result.

What does participation involve?

The information provided does not detail what taking part in this study specifically involves in terms of visits, assessments, medication, follow-up, or total duration. However, it's typical for studies like this to involve standard hospital care for your stroke, with the additional step of using the new Adaptive Tip Catheter as part of your treatment. You would likely have follow-up appointments to check on your recovery and how the treatment worked. Before joining, the study team would explain everything clearly, including how long the study would last for you.

Potential risks and benefits

The potential benefit of taking part is that you would receive care for your stroke using a potentially advanced device that could improve clot removal, possibly leading to a better recovery. However, as with any medical procedure, there are potential risks, which the study would outline in detail. These could include risks associated with stroke treatment itself, such as bleeding or infection, though the study aims to ensure the device is safe. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (15)

  • UZ Antwerpen
    Verified postcode
    Edegem, Belgium· Recruiting
  • Ghent University Hospital
    Verified postcode
    Ghent, Belgium· Recruiting
  • Universitair Ziekenhuis Leuven
    Verified postcode
    Leuven, Belgium· Recruiting
  • CHU Bordeaux
    Verified postcode
    Bordeaux, France· Not yet recruiting
  • CHU Nantes
    Verified postcode
    Nantes, France· Not yet recruiting
  • CHU Pitie Salpetriere
    Verified postcode
    Paris, France· Not yet recruiting
  • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
    Verified postcode
    Toulouse, France· Recruiting
  • CHRU de Tours
    Verified postcode
    Tours, France· Not yet recruiting
  • Universitaetsklinikum Heidelberg
    Verified postcode
    Heidelberg, Germany· Not yet recruiting
  • Universitatsklinikum Schleswig Holstein Kiel
    Verified postcode
    Kiel, Germany· Recruiting
  • Universitaetsmedizin Mainz
    Verified postcode
    Mainz, Germany· Recruiting
  • Stadtisches Klinikum Solingen gemeinnutzige GmbH
    Verified postcode
    Solingen, Germany· Recruiting

Common questions

What is an ischemic stroke?

It's a type of stroke caused by a blood clot that blocks blood flow to part of the brain.

What is the 'Adaptive Tip Catheter'?

It's a new medical device, a thin tube, that doctors are testing to see if it's safe and effective at removing blood clots during a stroke.

Will I get special treatment in this study?

You would receive your usual stroke care, with the specific new catheter being used as part of your treatment to remove the clot.

How long will the study last for me?

The study information doesn't specify an exact timeframe, but the study team will explain the duration during the consent process.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point without it affecting your medical care.

How to find out more

Adriana Popovici

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Pivotal Study Evaluating Safety and Effectiveness of Adapt…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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