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REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)

This study, called RECHRUT, is for people who have had a stroke because a large blood vessel in their brain was blocked. Doctors often try to remove the clot, but sometimes this doesn't fully clear the blockage. This study is testing a special, small metal tube called a CREDO® heal stent. This stent is designed to be left permanently in the blood vessel to help keep it open. The aim is to see if using this stent is a safe and effective way to reopen these blood vessels after a clot removal procedure hasn't been completely successful. This could help improve recovery for people who have had this type of stroke.

At a glance

Status
Recruiting
Sponsor
Acandis GmbH
Enrolment target
153
Start
25 Jan 2023
Estimated completion
01 Jan 2027

What is this study about?

When someone has a stroke caused by a blockage in a large blood vessel in their brain, doctors often try a procedure called a thrombectomy. This involves using special tools to remove the blood clot and restore blood flow. However, sometimes after this procedure, the blood vessel isn't completely open, or there might be an underlying narrowing that causes it to block again. This study is looking at what happens when a special device called a CREDO® heal stent is used in these situations. This stent is a small, permanent tube designed to keep the blood vessel open.

The main goal of this study is to check how well this CREDO® heal stent works and if it's safe to use. Researchers want to know if it can successfully reopen the blocked vessel and help people recover better after a stroke when other clot removal methods haven't fully worked. They will be using the CREDO® heal stent along with another device called a NeuroSpeed PTA Balloon Catheter, which helps to carefully expand the blood vessel before the stent is put in place.

By taking part in this study, you would be helping doctors and researchers understand if this specific stenting approach can be a good option for people who have had a stroke and whose blood vessels remain blocked or narrowed after initial treatment. The information gathered will contribute to improving future care for stroke patients.

Key takeaways

  • This study tests a special stent (CREDO® heal) for stroke patients.
  • It's for people whose main stroke treatment didn't fully clear a brain blood vessel blockage.
  • The stent aims to keep the blood vessel open permanently.
  • The goal is to see if this stent is safe and helps improve recovery.
  • Participation would mean receiving this specific stent as part of your stroke care.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. You would have had a stroke caused by a blockage in a large blood vessel in your brain within the last 24 hours. Crucially, the initial procedure to remove the clot must not have fully succeeded in opening the blood vessel, and the doctors must believe that the CREDO® heal stent could help. Also, before your stroke, you should have been able to carry out most of your daily activities without much help.

There are also some reasons why you might not be able to join. For example, if you have a known severe narrowing of your blood vessels that has caused repeated problems despite medication, or if you can't take certain blood-thinning medications that are vital for people with stents. You also can't be taking part in another clinical trial at the same time.

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 18 years old or older?
  2. Have you recently had a stroke in a large brain blood vessel?
  3. Did the initial clot removal treatment not fully clear the blockage?
  4. Before your stroke, were you able to manage your daily life mostly independently?
  5. Do you not have other serious health issues that would prevent you from having the stent or taking related medications?
Answer every question to see your result.

What does participation involve?

The information provided doesn't detail the exact number of visits, specific tests, or the total length of involvement for participants. However, if you're eligible, you would receive the CREDO® heal stent as part of your stroke treatment. You would likely have follow-up appointments and scans as part of your standard care, which the study would monitor. Any specific medications related to the stent, such as anti-clotting drugs, would be explained to you in detail. The study aims to follow you to see how well the stent works over time and how your recovery progresses.

Potential risks and benefits

It's important to weigh any potential benefits against possible risks. The potential benefit is that the CREDO® heal stent could successfully reopen a blocked blood vessel in your brain when other treatments haven't worked, potentially improving your stroke recovery. However, like any medical procedure, there are risks involved. These can include complications related to the procedure itself, such as bleeding, or risks associated with the stent being placed, like the need for blood-thinning medication. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (17)

  • Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau
    Verified postcode
    Aschaffenburg, Germany· Recruiting
  • Klinik für Diagnostische Radiologie und Neuroradiologie; Universitätsklinikum Augsburg
    Verified postcode
    Augsburg, Germany· Recruiting
  • Klinik für Diagnostische und Interventionelle Neuroradiologie; Universitätsklinikum Bonn
    Verified postcode
    Bonn, Germany· Recruiting
  • Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Bremerhaven-Reinkenheide
    Verified postcode
    Bremerhaven, Germany· Recruiting
  • Institut und Poliklinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum Dresden
    Verified postcode
    Dresden, Germany· Recruiting
  • Klinik für Radiologie und Neuroradiologie, Sana Klinikum
    Verified postcode
    Duisburg, Germany· Recruiting
  • Diagnostische und interventionelle Radiologie, Helios Klinikum Erfurt
    Verified postcode
    Erfurt, Germany· Recruiting
  • Diagnostische und Interventionelle Neuroradiologie, Universitätsmedizin Halle
    Verified postcode
    Halle, Germany· Recruiting
  • Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin, Asklepios Klinikum Altona
    Verified postcode
    Hamburg, Germany· Recruiting
  • Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf
    Verified postcode
    Hamburg, Germany· Recruiting
  • Radiologie / Neuroradiologie, Askleopis Klinik St. Georg
    Verified postcode
    Hamburg, Germany· Recruiting
  • Klinik für Neuroradiologie, Westpfalz-Klinikum
    Verified postcode
    Kaiserslautern, Germany· Recruiting

Common questions

What is a 'stent'?

A stent is a small, mesh-like tube that doctors can place inside a blood vessel to help keep it open. In this study, it's used in the brain.

What does 'unsuccessful thrombectomy' mean?

It means that the first procedure to remove a blood clot from your brain vessel didn't completely clear the blockage, or the vessel quickly became narrowed again.

Who is running this study?

The study is called RECHRUT (REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy).

Will I get special medicine if I join?

If you receive the stent, you will likely need to take special medications to prevent blood clots. These will be explained to you by your doctor.

Can I leave the study if I change my mind?

Yes, you can decide to leave the study at any time without it affecting your medical treatment.

How to find out more

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 "REscue Stenting With CREDO® Heal for Recanalisation After Un…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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