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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
594
Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite
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.
Baptist Medical Center
Jacksonville, Florida, United States
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.
Time frame: 90 ± 14 days follow-up
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.
Time frame: 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)
Time frame: 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 Randomized population.
Time frame: 90 ± 14 days follow-up
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Grady Memorial Hospital/Emory University
Atlanta, Georgia, United States
NOT_YET_RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
RECRUITINGLa Sagrada Familia Clinic
José Hernández, Argentina
RECRUITINGHospital Geral de Fortaleza
Fortaleza, Brazil
RECRUITINGHospital de Base
São José do Rio Preto, Brazil
NOT_YET_RECRUITINGHospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba
Vitória, Brazil
RECRUITINGHospices Civils de Lyon
Lyon, France
COMPLETEDCHU Montpellier
Montpellier, France
RECRUITINGBicêtre Hospital
Paris, France
RECRUITING...and 12 more locations