Stroke Trial, Recruiting NCT04562194 Sponsor: Vesalio Condition: Stroke
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Stroke Trial, Recruiting

NCT04562194
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must have already been treated with the NeVa thrombectomy device (a clot-removal tool) before being considered for this trial.
  • You are 18 years of age or older.
  • Your stroke symptoms are assessed as moderately severe or worse on a standard stroke scale (NIHSS score of 6 or higher).
  • Before your stroke, you were largely independent in daily life (confirm with trial site).
  • A blocked blood vessel in a specific part of your brain was confirmed by a specialised imaging scan called DSA.
  • The clot-removal procedure was started within 24 hours of when you were last known to be well.
  • Brain imaging shows that there is still salvageable brain tissue, the damaged area is not too large (no more than 50cc), and your brain scan score meets certain thresholds depending on how soon after symptoms treatment began (confirm with trial site).
  • You, or your legal representative, are able and willing to give consent to take part, either before or within a reasonable time after the procedure.

Who may not be able to join:

  • You have a pre-existing brain, neurological, or psychiatric condition (such as dementia treated with certain medications) that could affect how results are measured.
  • You have recently needed CPR, have a serious heart rhythm problem, signs of a heart attack, or concern about inhaling fluid into your lungs before treatment.
  • Your symptoms suggest you may have had strokes in more than one area of the brain at the same time.
  • You have inflammation of the blood vessels in the brain (cerebral vasculitis).
  • You have a history of a severe allergic reaction to contrast dye used in imaging scans.
  • You have a known allergy to the materials the NeVa device is made from (nitinol or stainless steel).
  • There is a suspicion that your symptoms are caused by a tear in the aorta, an infected clot, or a heart valve infection.
  • You currently have a significant infection throughout your body.
  • Brain imaging shows significant swelling causing a shift in brain structures.
  • You have a brain tumour (except for a small, non-aggressive type called a meningioma).
  • The NeVa device could not be used to make at least one treatment attempt for any reason.
  • Your life expectancy is less than 6 months.
  • The trial doctor believes that an endovascular (through the blood vessels) procedure would not be safe or suitable for you for any other reason.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Vesalio
Registry
ClinicalTrials.gov
Start date
1 July 2020
Est. completion
31 December 2026

Where this trial is recruiting

🇦🇷 Argentina 🇮🇹 Italy 🇦🇪 United Arab Emirates

Primary endpoints

First Pass Success Rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov