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

Philips Clinical & Medical Affairs Global

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.

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…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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 hour…

Interventions

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

Locations (23)

Baptist Medical Center
Jacksonville, Florida
Grady Memorial Hospital/Emory University
Atlanta, Georgia
Montefiore Medical Center
The Bronx, New York
La Sagrada Familia Clinic
José Hernández
UZ Brussels
Brussels
Hospital Geral de Fortaleza
Fortaleza