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

Last updated: May 27, 2025
Sponsor: Philips Clinical & Medical Affairs Global
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Direct to Angio Suite (DTAS) Philips' CBCT triage

Conventional CT/MR triage

Clinical Study ID

NCT04701684
XCY607-130512
  • Ages > 18
  • All Genders

Study Summary

The WE-TRUST study is a multi-center randomized clinical trial to assess the impact of a Direct to Angio Suite (DTAS) workflow on stroke patient outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is 18 years of age or older, or of legal age to give informed consent perstate or national law.

  • Baseline NIHSS score obtained prior to randomization must be equal or higher than 10points.

  • 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 astroke center (clinical investigational site participating in this study) < 6 hoursfrom symptom onset. Symptom onset is defined as point in time the patient was lastknown well (at baseline).

  • Informed consent obtained from patient or his or her legally designatedrepresentative (if locally required).

  • Angiography suite immediately available.

  • Endovascular treatment team immediately available (Neurologist,Neurointerventionist, Anesthesiologist, Nursing, Technicians as per local standardpractice)

Exclusion

Exclusion Criteria:

Clinical exclusion criteria:

  • Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulanttherapy 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 Hgor DBP > 110 mm Hg). Note: If the blood pressure can be successfully reduced andmaintained 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 notrequired to be redone in the Comprehensive Stroke Center as per discretion of thephysician or per local standards (e.g. CT/MR less then 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 transfercould be randomized only in case an NIHSS is obtained by a neurologist priortransportation).

  • 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 thanone 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 confoundthe neurological or functional evaluations, mRS score at baseline must be ≤2. Thisexcludes patients who are severely demented, require constant assistance in anursing home type setting or who live at home but are not fully independent inactivities of daily living (toileting, dressing, eating, cooking and preparingmeals, etc.)

  • Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitorfrom 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 thepatient if study therapy is initiated or affect the participation of the patient inthe study.

  • Subject participates in a potentially confounding drug or device trial during thecourse of the study.

  • Woman of childbearing potential who is known to be pregnant on admission.

  • Subject meets an exclusion criteria according to national law (e.g. age, pregnantwoman, breast feeding woman)

  • Subject is Philips employee or their family members residing with this Philipsemployee.

Study Design

Total Participants: 564
Treatment Group(s): 2
Primary Treatment: Direct to Angio Suite (DTAS) Philips' CBCT triage
Phase:
Study Start date:
June 23, 2021
Estimated Completion Date:
December 01, 2025

Study Description

Outcomes for stroke patients are closely tied to how fast they receive treatment. Currently, when a possible stroke patient arrives at the emergency department, typically first a CT or MRI exam is acquired for stroke triage. In case of an ischemic stroke the patient is then treated in an interventional suite.

In the DTAS workflow stroke patients are diagnosed and treated in the interventional suite without interruption. The Cone-Beam CT (CBCT) capabilities of the interventional X-ray system are utilized to perform triage, directly followed by stroke treatment.

The primary objective of the WE-TRUST study is to demonstrate that the DTAS triage workflow involving CBCT results in superior patient outcome in ischemic stroke patients with confirmed Large Vessel Occlusion as compared to the conventional CT/MR triage workflow.

The WE-TRUST study will be running in 16 sites to enroll 500+ patients globally.

Connect with a study center

  • La Sagrada Familia Clinic

    José Hernández,
    Argentina

    Active - Recruiting

  • Hospital Geral de Fortaleza

    Fortaleza,
    Brazil

    Active - Recruiting

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

    Vitória,
    Brazil

    Active - Recruiting

  • Hospices Civils de Lyon

    Lyon,
    France

    Completed

  • CHU Montpellier

    Montpellier,
    France

    Site Not Available

  • Bicêtre Hospital

    Paris,
    France

    Active - Recruiting

  • University Hospital Bonn (UKB Universitätsklinikum Bonn)

    Bonn, 53127
    Germany

    Active - Recruiting

  • Klinikum Kassel

    Kassel,
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein Lübeck

    Lübeck, 23562
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar der TU München

    Munich,
    Germany

    Active - Recruiting

  • Haaglanden Medical Center

    Den Haag,
    Netherlands

    Site Not Available

  • St. Antonius Ziekenhuis

    Nieuwegein,
    Netherlands

    Completed

  • University Emergency Hospital Bucharest

    Bucharest,
    Romania

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, Moncloa - Aravaca 28040
    Spain

    Active - Recruiting

  • Hospital Universitari de Bellvitge

    Barcelona,
    Spain

    Site Not Available

  • Vall d'Hebron University Hospital

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitari Doctor Josep Trueta de Girona

    Girona,
    Spain

    Site Not Available

  • Hospital Virgen del Rocio

    Sevilla,
    Spain

    Active - Recruiting

  • İstanbul Aydin University medical park florya hospital

    Istanbul,
    Turkey

    Completed

  • Baptist Medical Center

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Grady Memorial Hospital/Emory University

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • University of Massachusetts

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx, New York 10467
    United States

    Site Not Available

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