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)
Distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up — 90 ± 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.
Trial sites (24)
Facility
City
Region
Status
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
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.
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