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NeVa Retrospective Comparative SR Study

This study, called NITRO, is comparing two types of devices used in stroke treatment to unblock a blood vessel. When someone has an acute stroke because a large blood vessel in their brain is blocked, doctors might use a procedure called mechanical thrombectomy. This study looks at past patient information to see how well a device called the NeVa Stent Retriever worked compared to other similar devices. The main goal is to find out if the NeVa device is as safe and effective at clearing blood clots and restoring blood flow to the brain as other standard devices. This helps doctors choose the best treatments for patients experiencing this type of stroke.

At a glance

Status
Active not recruiting
Sponsor
Vesalio
Enrolment target
800
Start
15 Jun 2025
Estimated completion
01 Sep 2026

What is this study about?

When someone has a stroke, it's often because a blood clot blocks a vessel in their brain, stopping blood flow. If this happens in a large vessel, doctors sometimes use a special procedure called "mechanical thrombectomy." This involves using a small device to go into the blood vessel and pull out the clot. This study, called NITRO, is looking at how well one specific device, called the NeVa Stent Retriever, works compared to other similar devices commonly used. Think of a stent retriever as a tiny, specialised tool that helps doctors remove the blockage.

The researchers are reviewing existing medical records of patients who have already had this treatment. They want to compare the NeVa device with other standard devices that are approved for use in the UK and elsewhere. By doing this, they aim to understand if the NeVa device is just as good, or even better, at clearing the clot and restarting blood flow to the brain, and importantly, if it is just as safe for patients.

This kind of study, which looks at past information rather than treating new patients, helps doctors gather real-world information about how these devices perform in everyday medical practice. The results could help ensure that patients receive the most effective and safest treatment options available for acute stroke.

Key takeaways

  • This study compares two stroke treatment devices.
  • It uses existing patient medical records from the past.
  • The goal is to see which device clears blood clots and is safer.
  • You won't be asked to do anything new for this study.
  • Information is anonymised to protect your privacy.

Who may be eligible?

This study looks at past treatment information for adults aged 18 and over who had a severe stroke with a blocked large blood vessel in their brain. For patients to be included, their stroke treatment must have started within 8 hours of when they were last known to be well. They also needed to have severe stroke symptoms, but not so severe that a different treatment might be more suitable.

Another important point is that if they received clot-busting medication (IV-tPA), it either didn't work, or they weren't able to have that medication in the first place, or it was given within 3 hours. The study focused on patients who had a type of procedure called mechanical thrombectomy, where a stent retriever was used as the main way to remove the clot.

Patients would not be included if their blood clot was removed mainly by drawing it out with suction (called contact aspiration) alone, or if a device other than a standard stent retriever was used as the first treatment to remove the clot.

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. I was at least 18 years old when I had my stroke.
  2. My stroke was caused by a large blood vessel blockage.
  3. My treatment started within 8 hours of when I was last known to be well.
  4. I had a specific procedure called mechanical thrombectomy using a stent retriever.
  5. I either didn't get clot-busting medicine, or it didn't work.
Answer every question to see your result.

What does participation involve?

This study is different from many others because you won't be asked to do anything new. The researchers are looking at medical records of patients who have already had stroke treatment in the past. This means you do not need to attend extra visits, have additional assessments, take any medication, or have extra follow-up appointments for this particular study. Your medical information will be reviewed by the research team to understand the results of your treatment from your existing records.

Potential risks and benefits

Since this study looks at existing medical records, there are no direct new risks or benefits to you as a patient if your information is included. You will not undergo any new procedures or receive different care. The potential benefit of this study is that its findings could help doctors better choose the most effective and safest treatments for future stroke patients. All patient information is anonymised, meaning your name and personal details are removed to protect your privacy. You have the right to request that your medical records are not used for this type of research at any time, even if they have already been included.

Locations (5)

  • Hospital Espanol de Mendoza
    Verified postcode
    Mendoza, Argentina
  • CHU LIege
    Verified postcode
    Liège, Belgium
  • UK Munster
    Verified postcode
    Münster, Germany
  • Republican Vilnius University Hospital
    Verified postcode
    Vilnius, Lithuania
  • İstanbul Aydrn Üniversitesi
    Verified postcode
    Istanbul, Turkey (Türkiye)

Common questions

What is a 'mechanical thrombectomy'?

It's a medical procedure where doctors use a special device to physically remove a blood clot from a blocked artery in the brain, restoring blood flow.

What is a 'stent retriever'?

A stent retriever is a tiny, mesh-like device used during a thrombectomy. It's guided into the blocked artery, expands to 'trap' the clot, and then the clot is carefully pulled out.

Why is this study 'retrospective'?

Retrospective means the researchers are looking back at information from patients who have already had treatment, rather than enrolling new patients to receive treatment specifically for the study.

Will my personal details be safe?

Yes, by law, all patient information included in the study will be made anonymous. This means your name and other identifying details will be removed to protect your privacy.

Will participating in this study change my medical care?

No, because this study looks at past information, it will not change any care you have received or will receive in the future.

How to find out more

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

Discussion

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