🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT04701684
Recruiting Not applicable

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

NCT04701684 · tracked via the Priya Life Science USA tracker
Sponsor
Philips Clinical & Medical Affairs Global
Phase
Not applicable
Started
2021-06-23
Last updated
2026-09-04

Condition(s) studied

Stroke, Acute

Investigational drug(s) / intervention(s)

Direct to Angio Suite (DTAS) Philips' CBCT triageConventional CT/MR triage

Direct to Angio Suite (DTAS) Philips' CBCT triage: Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite

Conventional CT/MR triage: First a CT or MRI exam is acquired for triage. In case of an ischemic stroke the patient is then treated in an interventional suite.

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: Clinical exclusion criteria: * 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 meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman) * Subject is Philips employee or their family members residing with this Philips employee.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Baptist Medical Center Jacksonville Florida Recruiting
Grady Memorial Hospital/Emory University Atlanta Georgia Not Yet Recruiting
Montefiore Medical Center The Bronx New York Recruiting
La Sagrada Familia Clinic José Hernández Argentina Recruiting
UZ Brussels Brussels Belgium Recruiting
Hospital Geral de Fortaleza Fortaleza Brazil Recruiting
Hospital de Base São José do Rio Preto Brazil Not Yet Recruiting
Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba Vitória Brazil Recruiting
Hospices Civils de Lyon Lyon France Completed
CHU Montpellier Montpellier France Recruiting
Bicêtre Hospital Paris France Recruiting
University Hospital Bonn (UKB Universitätsklinikum Bonn) Bonn Germany Recruiting
Klinikum Kassel Kassel Germany Recruiting
Universitätsklinikum Schleswig-Holstein Lübeck Lübeck Germany Recruiting
Klinikum rechts der Isar der TU München Munich Germany Recruiting
St. Antonius Ziekenhuis Nieuwegein Netherlands Completed
Haaglanden Medical Center The Hague Netherlands Withdrawn
University Emergency Hospital Bucharest Bucharest Romania Not Yet Recruiting
Hospital Clinico San Carlos Madrid Moncloa - Aravaca Recruiting
Vall d'Hebron University Hospital Barcelona Spain Recruiting
Hospital Universitari Doctor Josep Trueta de Girona Girona Spain Recruiting
Hospital Virgen del Rocio Seville Spain Recruiting
İstanbul Aydin University medical park florya hospital Istanbul Turkey (Türkiye) Completed
İstinye Üniversitesi Gaziosmanpaşa Hastanesi Istanbul Turkey (Türkiye) Not Yet Recruiting

More Philips Clinical & Medical Affairs Global trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04701684 on ClinicalTrials.gov ↗ ← All trials in the USA