WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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 | 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.
View NCT04701684 on ClinicalTrials.gov ↗ ← All trials in the USA