All studies
Active not recruitingNAINTERVENTIONAL

Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever

The DISTALS Study is investigating a new treatment for a specific type of stroke, called an ischemic stroke, where a blood clot blocks a small vessel in the brain. The treatment involves a device called the Tigertriever 13, which is designed to physically remove these clots and restore blood flow. Researchers want to find out if this device is safe and works better than current medical treatment for patients who have had this type of stroke within 24 hours. The study will look at how well blood flow is restored and if it helps patients recover. Currently, there isn't a widely accepted device for these smaller, more distant brain clots, so this research is important for potentially offering a new option.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
Rapid Medical
Enrolment target
168
Start
25 Mar 2022
Estimated completion
01 Mar 2026

What is this study about?

This study, called DISTALS, is looking into a new way to treat a type of stroke. When you have an ischemic stroke, it means a blood clot has blocked a blood vessel in your brain, stopping blood and oxygen from getting to parts of your brain. This study is specifically for people whose stroke is caused by a clot in a smaller, more distant blood vessel in the brain, which doctors call a 'distal vessel occlusion' (DVO).

Currently, there isn't a standard device treatment for these smaller clots, and doctors usually rely on medicine. This study is testing a new device called the Tigertriever 13. This device is designed to be carefully inserted into the blood vessel to grab and remove the clot, hopefully restoring blood flow. The main goal is to see if using this device is safe and whether it's more effective at clearing the blockage and helping people recover than just standard medical care alone.

Finding better ways to treat these specific strokes is really important. If the Tigertriever 13 proves to be safe and effective, it could offer a new treatment option for many people who experience this kind of stroke, helping to reduce the long-term impact of stroke and improve recovery.

Key takeaways

  • This study is testing a new device (Tigertriever 13) for a specific type of stroke.
  • It aims to see if the device safely and effectively removes blood clots from small brain vessels.
  • The study compares the new device to standard medical care.
  • It involves adults aged 18-85 who have had a stroke within 24 hours.
  • Participation involves potential benefits of a new treatment, but also includes risks.

Who may be eligible?

To join this study, participants generally need to be between 18 and 85 years old. Before their stroke, they should have been able to carry out their daily activities without much help. The stroke must be disabling, meaning it affects their ability to do things like bathing or walking, and it needs to be caused by a blockage in a specific type of smaller brain blood vessel that measures at least 1.5mm across. The stroke symptoms must have started within the last 24 hours.

There are also some specific findings on brain scans that would be needed, showing a certain amount of brain tissue at risk from the stroke but not too much damage already done. For some people, particular stroke symptoms like speech problems or vision loss might also be considered.

However, some conditions would mean you can't join. For example, if your brain scans show there's bleeding in the brain, or if you've already had a different procedure to clear the same blood vessel. If there are other blockages that are too difficult to reach, or if the initial stroke was part of a blockage in a much larger vessel, you wouldn't be able to take part.

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 85 years old?
  2. Did you generally live independently before your stroke?
  3. Did your stroke symptoms start within the last 24 hours?
  4. Is your stroke affecting your ability to do daily activities?
  5. Have doctors identified a blockage in a smaller blood vessel in your brain?
  6. Are your brain scans clear of any bleeding?
Answer every question to see your result.

What does participation involve?

The study involves evaluating a new treatment called the Tigertriever 13. If you join, you would either receive the Tigertriever 13 treatment or standard medical care. There will be initial brain scans and evaluations when you first come to the hospital. If you receive the Tigertriever 13, a doctor will perform the procedure to try and remove the clot. After this, there will be follow-up appointments and scans over a period of time to monitor your recovery and the effects of the treatment. These check-ups will assess how well you are doing, including your day-to-day abilities and any changes in your stroke symptoms. The total duration of your participation, including all follow-up visits, would be explained to you in detail by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving an experimental treatment with the Tigertriever 13, which could be more effective than current standard care for unblocking vessels and improving recovery from your stroke. However, as with any medical procedure, there are potential risks involved, such as complications during the procedure or side effects from the device. These will be fully explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (20)

  • Lakewood Regional Medical Center
    Verified postcode
    Los Angeles, United States
  • Los Robles
    Verified postcode
    Thousand Oaks, United States
  • WellStar Research Institute
    Verified postcode
    Marietta, United States
  • Advocate Aurora Research Institute,
    Verified postcode
    Chicago, United States
  • Corewell Health (Spectrum)
    Verified postcode
    Grand Rapids, United States
  • Munson Medical Center
    Verified postcode
    Traverse City, United States
  • University of Buffalo
    Verified postcode
    Buffalo, United States
  • NYU Langone Health
    Verified postcode
    New York, United States
  • Mount Sinai
    Verified postcode
    New York, United States
  • Stony Brook University
    Verified postcode
    Stony Brook, United States
  • Mercy Health
    Verified postcode
    Toledo, United States
  • Semmes Murphey Foundation
    Verified postcode
    Memphis, United States

Common questions

What is an ischemic stroke?

An ischemic stroke happens when a blood clot blocks a blood vessel in your brain, stopping blood flow and damaging brain cells.

What is the Tigertriever 13?

The Tigertriever 13 is a small device designed to be carefully inserted into a blocked blood vessel in the brain to remove a clot and restore blood flow.

Who is eligible for this study?

Generally, adults aged 18-85 who have recently had a disabling stroke caused by a clot in a small brain vessel, and meet specific criteria from brain scans.

Will I definitely receive the new device?

No, you might receive the Tigertriever 13 device or standard medical care, depending on which group you are assigned to in the study.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, and this will not affect your medical care.

How to find out more

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

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