Stroke, Acute
Conditions
Brief 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.
Detailed 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-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.
Interventions
DEVICEDirect to Angio Suite (DTAS) Philips' CBCT triage
Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite
PROCEDUREConventional 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.
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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)
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median time measurements (door-to-arterial puncture time) | Peri-procedural 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) | Peri-procedural 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 | 90 ± 14 days follow-up | The distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up in both arms in the Randomized population. |
Countries
Argentina, Belgium, Brazil, France, Germany, Netherlands, Romania, Spain, Turkey (Türkiye), United States
Contacts
CONTACTGerrits
CONTACTEshuis
PRINCIPAL_INVESTIGATORRaul G Nogueira
UPMC Stroke Institute, Pittsburgh
PRINCIPAL_INVESTIGATORMarc Ribo
Vall d'Hebron University Hospital, Barcelona
Outcome results
None listed