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

Prior treatment

• 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 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).
• Subject participates in a potentially confounding drug or device trial during the course of the study.

Other illness

• 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).
• 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
• 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.)
• 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.

Lab values

• 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)

Age

• Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman)

Other

• Clinical exclusion criteria:
• Patients with extreme vomiting
• Patients that are extremely agitated
• Cerebral vasculitis
• 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
• Woman of childbearing potential who is known to be pregnant on admission.
• Subject is Philips employee or their family members residing with this Philips employee.

• 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)