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

Study Overview
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Brief Summary
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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.

Detailed Description
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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-TRUST study is to demonstrate that the DTAS triage workflow involving CBCT results in superior patient outcome in ischemic stroke patients with confirmed Large Vessel Occlusion as compared to the conventional CT/MR triage workflow. The WE-TRUST study will be running in 16 sites to enroll 500+ patients globally.

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

Conditions
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Stroke, Acute

Intervention / Treatment
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* Device: Direct to Angio Suite (DTAS) Philips' CBCT triage
* Procedure: Conventional CT/MR triage


Participation Criteria
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Eligibility Criteria
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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. 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, Neurointerventionist, 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 then 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct tot Angiography Suite (DTAS) triage workflow<br> | Device: Direct to Angio Suite (DTAS) Philips' CBCT triage<br>* Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite<br>|
| Active Comparator: Conventional CT/MR triage workflow<br> | Procedure: Conventional CT/MR triage<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of ordinal modified Rankin Scale (mRS) scores at 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 ITT population to determine the performance of the DTAS triage imaging workflow involving Stroke CBCT reconstructions by the investigational device 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 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. | 90 ± 14 days follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time measurements (door-to-arterial puncture time) | Door-to-arterial puncture time: Time patient arrives at the Comprehensive Stroke Center door to the time the skin of the patient is touched to perform first arterial puncture. | Peri-procedural time | 
| Median time measurements (door-to-reperfusion time) | Door-to-reperfusion time: Time patient arrives at the Comprehensive Stroke Center door to the time of successful vessel recanalization (eTICI ≥ 2b) | Peri-procedural time | 
| Distribution of ordinal modified Rankin Scale (mRS) scores | The distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up in both arms in the ITD population to determine the difference of the DTAS triage imaging workflow involving Stroke CBCT reconstructions by the investigational device in comparison to the conventional CT/MR triage imaging workflow in all randomized suspected stroke patients | 90 ± 14 days follow-up |