What this study is
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.
What's being tested
- Direct to Angio Suite (DTAS) Philips' CBCT triage
Intervention · DEVICE
Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite
- Conventional CT/MR triage
Intervention · PROCEDURE
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 details
- Sponsor
- Philips Clinical & Medical Affairs Global
- Conditions
- Stroke, Acute
- Enrolling
- 594 people
- Starts
- 2021-06-23
- Est. completion
- 2027-04-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (24)
20 openBaptist Medical Center
Jacksonville, Florida, United States
- Ricardo Hanel · Contact
RecruitingGrady Memorial Hospital/Emory University
Atlanta, Georgia, United States
- Diogo Haussen · Contact
- Raul Nogueira · Contact
Not yet recruitingMontefiore Medical Center
The Bronx, New York, United States
- Seon Kyu Lee · Contact
Recruiting
21 sites outside the US
La Sagrada Familia Clinic
José Hernández, Argentina
- Pedro Lylyk · Contact
RecruitingUZ Brussels
Brussels, Belgium
- Frans van den Bergh · Contact
- Sylvie de Raedt · Contact
RecruitingHospital Geral de Fortaleza
Fortaleza, Brazil
- Francisco Mont' Alverne · Contact
- Fabricio Oliveira Lima · Contact
RecruitingHospital de Base
São José do Rio Preto, Brazil
- Raquel Hidalgo · Contact
Not yet recruitingHospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba
Vitória, Brazil
- Derval Pimentel · Contact
- Leandro De Assis Barbosa · Contact
RecruitingCHU Montpellier
Montpellier, France
- Vincent Costalat · Contact
- Caroline Arquizan · Contact
RecruitingBicêtre Hospital
Paris, France
- Laurent Spelle · Contact
RecruitingUniversity Hospital Bonn (UKB Universitätsklinikum Bonn)
Bonn, Germany
- Felix Bode · Contact
RecruitingKlinikum Kassel
Kassel, Germany
- Christian Roth · Contact
- Ralf Siekmann · Contact
RecruitingUniversitätsklinikum Schleswig-Holstein Lübeck
Lübeck, Germany
- Peter Schramm · Contact
- Georg Royl · Contact
RecruitingKlinikum rechts der Isar der TU München
Munich, Germany
- Tobias Boeckh-Behrens · Contact
RecruitingUniversity Emergency Hospital Bucharest
Bucharest, Romania
- Razvan Radu · Contact
- Christina Tiu · Contact
RecruitingHospital Clinico San Carlos
Madrid, Moncloa - Aravaca, Spain
- Manuel Moreu · Contact
- Carlos Gomez Escalonilla · Contact
RecruitingVall d'Hebron University Hospital
Barcelona, Spain
- Marc Ribo · Contact
RecruitingHospital Universitari Doctor Josep Trueta de Girona
Girona, Spain
- Mikel Terceño · Contact
- Yolanda Silva · Contact
RecruitingHospital Virgen del Rocio
Seville, Spain
- Alejandro Gonzalez · Contact
- Francisco Moniche · Contact
Recruitingİstinye Üniversitesi Gaziosmanpaşa Hastanesi
Istanbul, Turkey (Türkiye)
- Serdar Geyik · Contact
- Sena Aksoy · Contact
Not yet recruitingHospices Civils de Lyon
Lyon, France
CompletedSt. Antonius Ziekenhuis
Nieuwegein, Netherlands
CompletedHaaglanden Medical Center
The Hague, Netherlands
Withdrawnİstanbul Aydin University medical park florya hospital
Istanbul, Turkey (Türkiye)
Completed
Study team
Sponsor
Philips Clinical & Medical Affairs Global
Study ID XCY607-130512
Principal investigator
Raul G Nogueira
UPMC Stroke Institute, Pittsburgh
Principal investigator
Marc Ribo
Vall d'Hebron University Hospital, Barcelona
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.