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.
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).
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.
Parallel
Direct to Angio Suite (DTAS) Philips' CBCT triage
DeviceStroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite
Conventional CT/MR triage
Procedure/SurgeryFirst a CT or MRI exam is acquired for triage. In case of an ischemic stroke the patient is then treated in an interventional suite.
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 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.
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.
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)
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 Randomized population.
Safety: Adverse events (mortality at 90 days)
Mortality and stroke-related mortality
Safety: Adverse events (symptomatic ICH)
All intracranial hemorrhages will be classified by the blinded Core Lab using the Heidelberg Bleeding Classification. Symptomatic ICH will be defined as per a modified SITS-MOST definition \[31\]: Symptomatic intracranial hemorrhage is defined as local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage on the 24 (-12/+24) hours post-treatment imaging scan, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 (-12/+24) hours after randomization, or leading to death.
Safety: Adverse events (asymptomatic ICH)
All intracranial hemorrhages will be classified (blinded) by using the Heidelberg Bleeding Classification. All the intracranial hemorrhages which are not symptomatic, are classified as asymptomatic.
Safety: Adverse events (other)
including information of the seriousness, treatment needed, resolution and relevant judgment concerning the causal relationship with the investigational device, SmartCT R3, comparator (CT/MR), or procedure will be summarized for safety information.
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