Clinical trial NCT04701684: WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)
Official title: WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2021-01-08
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up
timeFrame: 90 ± 14 days follow-up
Secondary outcomes:
measure: Median time measurements (door-to-arterial puncture time)
timeFrame: Peri-procedural time
measure: Median time measurements (door-to-reperfusion time)
timeFrame: Peri-procedural time
measure: Distribution of ordinal modified Rankin Scale (mRS) scores
timeFrame: 90 ± 14 days follow-up
Other outcomes:
measure: Safety: Adverse events (mortality at 90 days)
timeFrame: At 90 days post-procedure
measure: Safety: Adverse events (symptomatic ICH)
timeFrame: At 24 (-12/+24) hours
measure: Safety: Adverse events (asymptomatic ICH)
timeFrame: At 24 (-12/+24) hours
measure: Safety: Adverse events (other)
timeFrame: From start of enrollment until hospital discharge (e.g. up to 5 days)
measure: Safety: Adverse Device Effects
timeFrame: From start of enrollment until hospital discharge (e.g. up to 5 days)
measure: Safety: Number of participants with Device Deficiencies that could have led to Serious Adverse Event
timeFrame: From start of enrollment until hospital discharge (e.g. up to 5 days)
measure: Exploratory: Median time measurements (door-to-randomization time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (door-to-imaging time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (randomization-to-imaging time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (randomization-to-puncture time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (door-to-thrombolytics administration time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (onset-to-door time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (onset-to-arterial puncture time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (onset-to-successful reperfusion (eTICI ≥ 2b) time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (Emergency Medical Services call-to-door time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (Comprehensive Stroke Center notification call-to-door time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (imaging-to-thrombolytics administration time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (imaging-to-arterial puncture time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (Door-to-device deployment (first pass) time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (imaging-to-successful reperfusion (eTICI ≥ 2b) time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (arterial puncture-to-successful reperfusion (eTICI ≥ 2b) time)
timeFrame: Peri-procedural time
measure: Exploratory: Median time measurements (arterial puncture-to-skin closure time)
timeFrame: Peri-procedural time
measure: Exploratory: Degree of disability (other clinical outcome)
timeFrame: At discharge or 5-7 days post-procedure, and at 90 ± 14 days post-procedure
measure: Exploratory: NIHSS (other clinical outcome)
timeFrame: At admission (baseline), discharge or at 5-7 days post-procedure, whichever comes; and at 90 ± 14 days post-procedure
measure: Exploratory: Functional independence (other clinical outcome)
timeFrame: At 90 ± 14 days post-procedure
measure: Exploratory: UW-mRS (other clinical outcome)
timeFrame: At 90 ± 14 days post-procedure
measure: Exploratory: Dichotomized mRS score (other clinical outcome)
timeFrame: At 90 ± 14 days post-procedure
measure: Exploratory: Infarct volume (other clinical outcome)
timeFrame: At 24 (-12/+24) hours post-procedure
measure: Exploratory: Dramatic early favorable response (other clinical outcome)
timeFrame: At 24 (-12/+24) hours
measure: Exploratory: Successful vessel recanalization (other clinical outcome)
timeFrame: At the end of the endovascular procedure
measure: Exploratory: X-ray radiation exposure (other clinical outcome)
timeFrame: On day 1
Locations:
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital/Emory University
state: Georgia
city: The Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: José Hernández
country: Argentina
facility: La Sagrada Familia Clinic
city: Fortaleza
country: Brazil
facility: Hospital Geral de Fortaleza
city: Vitória
country: Brazil
facility: Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Montpellier
country: France
facility: CHU Montpellier
city: Paris
country: France
facility: Bicêtre Hospital
city: Bonn
country: Germany
facility: University Hospital Bonn (UKB Universitätsklinikum Bonn)
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Lübeck
city: Munich
country: Germany
facility: Klinikum rechts der Isar der TU München
city: Den Haag
country: Netherlands
facility: Haaglanden Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Bucharest
country: Romania
facility: University Emergency Hospital Bucharest
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
state: Moncloa - Aravaca
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
city: Girona
country: Spain
facility: Hospital Universitari Doctor Josep Trueta de Girona
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Istanbul
country: Turkey
facility: İstanbul Aydin University medical park florya hospital
Study officials:
affiliation: UPMC Stroke Institute, Pittsburgh
name: Raul G Nogueira
role: PRINCIPAL_INVESTIGATOR
affiliation: Vall d'Hebron University Hospital, Barcelona
name: Marc Ribo
role: PRINCIPAL_INVESTIGATOR
References: