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WE-TRUST Study for Ultra-fast Stroke Treatment

The WE-TRUST study is looking at new ways to treat acute ischemic stroke (a stroke caused by a blood clot). This study compares two approaches: the "Direct to Angio Suite (DTAS) Philips' CBCT triage" method, where diagnosis and treatment happen in the same room, versus the "Conventional CT/MR triage" method, where you first get a CT or MRI scan and then move to another room for treatment. The goal is to see if the DTAS method leads to better outcomes for patients with a confirmed large vessel occlusion (a blockage in a major brain artery). You might be able to join if you are 18 or older, have a certain stroke severity score (NIHSS score of 10 or higher), and had good function before your stroke. The study aims to enroll 594 participants, but its current status is unclear.

Study design
This is a multi-center randomized clinical trial, meaning participants are assigned by chance to one of the two treatment groups. The study plans to enroll 594 participants globally.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your functional ability will be assessed about 90 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04701684

WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)

Recruiting
NAAges 18+InterventionalDiagnostic
Philips Clinical & Medical Affairs Global
~594 participants
Updated 2026-09-04 on ClinicalTrials.gov
What's tested:Direct to Angio Suite (DTAS) Philips' CBCT triageConventional CT/MR triage

At a glance

Recruiting sites
16 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up
Measured over 90 ± 14 days follow-up

Conditions

Stroke, Acute

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Acute Ischemic Stroke

NCT04701684

Where you'd take part

This study runs at 24 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baptist Medical Center

    Jacksonville, Floridano site contact published

    Recruiting

  • Bicêtre Hospital

    Paris, Franceno site contact published

    Recruiting

  • CHU Montpellier

    Montpellier, Franceno site contact published

    Recruiting

  • Grady Memorial Hospital/Emory University

    Atlanta, Georgiano site contact published

    Not yet recruiting

  • Hospital Clinico San Carlos

    Madrid, Moncloa - Aravaca, Spainno site contact published

    Recruiting

  • Hospital de Base

    São José do Rio Preto, Brazilno site contact published

    Not yet recruiting

  • Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba

    Vitória, Brazilno site contact published

    Recruiting

  • Hospital Geral de Fortaleza

    Fortaleza, Brazilno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Raul G Nogueira · PRINCIPAL_INVESTIGATOR · UPMC Stroke Institute, Pittsburgh
  • Marc Ribo · PRINCIPAL_INVESTIGATOR · Vall d'Hebron University Hospital, Barcelona

Who to contact

Gerrits
[email protected]
+31 6 55 48 29 31
Email the study team

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Eligibility criteria

Inclusion

Subject is 18 years of age or older, or of legal age to give informed consent per state or national law.
Baseline NIHSS score obtained prior to randomization must be equal or higher than 10 points.
Subjects with no significant pre-stroke functional disability (modified Rankin scale 0 - 2).
Subjects suspected of acute ischemic stroke with an estimated arrival time at a stroke center (clinical investigational site participating in this study) \< 6 hours from symptom onset OR wake-up stroke with time last known well of \< 12 hours and symptoms discovered within 6 hours from arrival time at a stroke center. Symptom onset is defined as point in time the patient was last known well (at baseline).
Informed consent obtained from patient or his or her legally designated representative (if locally required).
Angiography suite immediately available.
Endovascular treatment team immediately available (Neurologist, Neurointerventionalist, Anesthesiologist, Nursing, Technicians as per local standard practice)

Exclusion

Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0
Known baseline platelet count \< 30.000/μL
Baseline blood glucose of \< 50mg/dL (\< 2.78mmol/l)
For patients receiving thrombolysis: severe, sustained hypertension (SBP \> 185 mm Hg or DBP \> 110 mm Hg). Note: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA/ASA guidelines recommended medication (including IV antihypertensive drips), the patient can be enrolled.
Patients from a transfer center (Primary Stroke Center) with a CT/MR that is not required to be redone in the Comprehensive Stroke Center as per discretion of the physician or per local standards (e.g. CT/MR less than 90 minutes old).
Patients in coma (NIHSS item of consciousness \>1) defined as totally unresponsive; responding only with reflexes or being areflexic (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation).
Patients with extreme vomiting
Patients that are extremely agitated
Seizures at stroke onset which would preclude obtaining a baseline NIHSS
Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
Patients acquired stroke while in-hospital
History of life-threatening allergy (more than rash) to contrast medium
Cerebral vasculitis
Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤2. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).
Patients with unstable clinical status who require emergent life support care
Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
Subject participates in a potentially confounding drug or device trial during the course of the study.
Woman of childbearing potential who is known to be pregnant on admission.
Subject is Philips employee or their family members residing with this Philips employee.

What this trial measures

  • Distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up90 ± 14 days follow-up

    The difference in the distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up in the Target population to determine the performance of the DTAS triage imaging workflow involving Stroke CBCT reconstructions by the investigational device or SmartCT R3 in comparison to the conventional CT/MR triage imaging workflow. The 90 day mRS score will be evaluated by a blinded assessor of a pool of blinded assessors (i.e., a specialist with mRS certification) at the local hospital by performing a structured interview of the patient in person using the Rankin Focused Assessment (RFA) structured mRS questionnaire. If the subject is unable to return to the clinic for the day 90 ± 14 visit, a (video) call in which the mRS score is assessed by a blinded assessor is preferable to no assessment.