Stroke Trial, Recruiting NCT04701684 Sponsor: Philips Clinical & Medical Affairs Global Condition: Stroke
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Stroke Trial, Recruiting

NCT04701684
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:

  • People who are 18 years of age or older, or who meet the legal age for giving consent in their country or state.
  • People who score 10 points or higher on a standard stroke severity scale (called the NIHSS) measured before being enrolled in the trial.
  • People who had little to no disability in their daily life before the stroke (scored 0–2 on a standard disability scale called the modified Rankin Scale).
  • People suspected of having an acute (sudden-onset) ischemic stroke who can arrive at a participating stroke centre within 6 hours of symptoms starting, OR people who had a stroke during sleep, where the last time they were known to be well was within 12 hours, and their symptoms were discovered within 6 hours of arriving at a stroke centre.
  • People for whom consent has been given — either by themselves or by a legally authorised representative, where required by local rules.
  • People being treated at a site where the equipment and specialist team needed for the procedure (including a neurologist, an interventional specialist, an anaesthesiologist, nursing staff, and technicians) are immediately available.

Who may not be able to join:

  • People with a known bleeding disorder, a clotting factor deficiency, or who are on blood-thinning medication with a clotting level (INR) above 3.0.
  • People with a known very low platelet count (below 30,000/μL) before the stroke.
  • People with a very low blood sugar level (below 50 mg/dL or 2.78 mmol/L) at the time of assessment.
  • People receiving clot-dissolving treatment who have severely elevated blood pressure that cannot be brought under control using standard medications.
  • People transferred from another hospital whose brain scan (CT or MR) is less than 90 minutes old and does not need to be repeated, based on the treating doctor's judgement or local practice.
  • People who are in a coma — meaning they are completely unresponsive or responding only with basic reflexes (intubated patients transferred from another facility may still be considered if a neurologist assessed their stroke severity before transport).
  • People experiencing severe, uncontrolled vomiting.
  • People who are extremely agitated.
  • People who had seizures at the time the stroke started, which would prevent a reliable stroke severity score from being obtained.
  • People with a serious, advanced, or terminal illness where life expectancy is less than one year.
  • People whose stroke occurred while they were already in hospital.
  • People with a known life-threatening allergy (more serious than a skin rash) to contrast dye used in imaging.
  • People with inflammation of the blood vessels in the brain (cerebral vasculitis).
  • People with a pre-existing neurological or psychiatric condition that would make it difficult to reliably assess their neurological or functional status — including people who are severely affected by dementia, require full-time care in a nursing home, or are not fully independent in daily activities such as toileting, dressing, eating, and preparing meals.
  • People who are unlikely to be available for a follow-up appointment at 90 days (for example, people with no fixed address or visitors from overseas).
  • People whose overall health is unstable and who require emergency life-support care.
  • People who have any other condition that, in the treating doctor's judgement, could make study participation unsafe or affect the reliability of the results.
  • People who are already participating in another drug or device trial that could interfere with this study.
  • People who are pregnant at the time of admission and are of childbearing age.
  • People who are excluded under the laws of their country (for example, based on age, pregnancy, or breastfeeding status).
  • People who are employed by Philips, or are family members living with a Philips employee.

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 16 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.

Contact this trial

Principal Investigator: Raul G Nogueira, UPMC Stroke Institute, Pittsburgh

Phone: +31 6 55 48 29 31

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Philips Clinical & Medical Affairs Global
Registry
ClinicalTrials.gov
Start date
23 June 2021
Est. completion
1 April 2027

Where this trial is recruiting

🇦🇷 Argentina 🇧🇪 Belgium 🇧🇷 Brazil 🇫🇷 France 🇩🇪 Germany 🇳🇱 Netherlands 🇷🇴 Romania 🇪🇸 Spain Turkey (Türkiye) 🇺🇸 United States

Primary endpoints

Distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up

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: 16 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